Our client is a highly successful consumer technologies innovator with operations on a global scale. Sustained record growth over the past decade has led to increased market share and exposure to new markets.

To support this growth a new opportunity has been created for a Supplier Development Manager (Asia) to join our client’s China based operations to support procurement and improve management of their Asian supplier base.

This is an excellent opportunity for a highly capable and accomplished Supply Chain/Supplier Development Manager to join our client’s Shenzhen operations in a pivotal leadership role.

Responsibilities:

• Management of procurement operations based in China, including general administration and legal responsibilities as required.
• Management and leadership of the Shenzhen supplier quality development team.
• Lead the development of a high quality, stable supply base within Asia to support global supply operations.
• Provide guidance and support to regional staff regarding issues associated with dealing across cultural boundaries.
• Maintain positive relationships at all levels with suppliers, keeping them updated with activities and opportunities.
• Implement statistical tools across the supplier base to drive a culture of continuous improvement.
• Work with suppliers and align them with corporate and regulatory manufacturing/quality requirements.
• Develop and deliver a targeted cost reduction program without compromising quality and delivery of components/product.
• Act as on-site representatives for any short or long-term quality issues – this may require extended overseas visits.
• Lead searches for new suppliers as required by global manufacturing operations.
• Organise contractual and confidentiality arrangements with suppliers where required.
• Work with procurement teams to provide onsite support for price negotiations. This includes direct responsibility for face to face negotiations and developing options within defined boundaries.
• Ensure that activities are carried out by the Supplier Development Group are in compliance with established quality control policies/work instructions.

Requirements:

• B.Eng./Bachelor of Business with extensive experience (15+ years) in a purchasing/engineering or QA role dealing with suppliers and technical/commercial issues.
• Experience in Automotive, Aerospace, Rail, Medical Device or other regulated industry.
• Fluent in Chinese (Mandarin required, Cantonese optional), and English languages
• Considerable recent experience working for a Western business organisation including travel outside of Asia in a supplier development, quality assurance or business development role.
• Computer experience – preparing spreadsheet analysis where required; preparing commercial letters; proficient in using formulas and/or macros.

Remuneration:

Salary: ¥ Excellent plus benefits

For more information, or to apply, contact Diarmuid on +612 8096 0060 / dsexton@adroitpeople.com.au

Alternatively, you can register your CV directly to our database:

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Our client is a leading pharmaceutical multinational with operations globally. Sustained record growth over the past decade has led to increased market share and exposure to new markets.

To support this growth a new opportunity has been created for a Quality Assurance Manager to join our client’s Canberra based operations in ensuring the highest commitment to quality systems, regulatory compliance and product quality.

Responsibilities:

• Design, develop and maintain quality assurance management plans across all areas of business
• Develop standards, methods or procedures to determine product quality or release readiness
• Facilitate in process risk assessments ( e.g. validation protocols and other reports)
• Implement ongoing quality improvement processes across all areas
• Identify deviances from standards, and suggest modifications to ensure compliance
• Develop and monitor quality budgets and spending
• Mange quality engineering, lab lead lab tech and other technical quality functions to support manufacturing and development programs
• Guide effective changes to regulatory guidelines and standards
• Maintain quality systems through internal and external quality audits
• Manage actions plans from audits to ensure all non-compliances are addressed within given timeframe
• Identify and maintain GMP contracts with suppliers and customers
• Ensure all TGA product registrations, licences and certificates are current
• Responsible for driving change initiatives and continuous improvement

Requirements:

• Bachelor of Science or equivalent with a minimum of 5 years practical experience in the pharmaceutical industry ideally in clinical research, QA / QC/  technical/ manufacturing
• Knowledge and experience with FDA, Medsafe , ISO 9001 and 13485
• Sound working knowledge of Australian Gxps (i.e. GWP, GMP, GDP, GCP) related to Medicines in Schedules 2,3,4 and 8 and medical devices
• Excellent verbal and written communication skills
• Knowledge of risk management, design control, process validation, inspection and auditing
• ASQ Quality Engineer, Quality Manager and/ or Six Sigma Black Belt certification desirable
• Involvement and/or understanding of state DPCP requirements, samples distribution and clinical trials beneficial
• Strong analytical and problem solving skills
• Advanced knowledge in Microsoft Suite

Remuneration:

Salary: $ Excellent plus benefits & bonuses

For more information, or to apply, call Diarmuid on +612 8096 0060 / email your application below.

Alternatively, you can register your CV directly to our database:

The post Quality Assurance Manager | Canberra appeared first on Adroit People.

Our client is a leading pharmaceutical multinational with operations on a global scale. Due to continued growth our client is now seeking an experienced GMP Auditor for its Shanghai operations. In this role you will responsible for planning and conducting quality audits (GMP) for approved and prospective suppliers within China.

This is an outstanding opportunity to work with a global leader in a critical stage of growth and will suit an accomplished professional seeking to further their career in a dynamic and rewarding environment.

Responsibilities:

• Plan, conduct and execute supplier audits in accordance with GMP regulations, operating procedures and quality policies.
• Develop policies and procedures for audit programs to ensure suppliers maintain regulatory requirements.
• Manage post-audit activities and recommend corrective and preventative actions regarding compliance concerns, reviews and implementation management.
• Communicate audit results to management and commercial teams.
• Work with suppliers to develop processes and regulatory guidelines to improve quality and consistency in supplier performance in accordance with regulatory and corporate requirements.
• Manage and coordinate the activities of the audit team
• Assist in the training of new quality auditing staff
• Ensure written procedures are followed
• Draft and issue periodic reports to site management as requested
• Effectively cooperate with departments across the company to analyse and resolve technical issues in accordance to quality standards
• Support regulatory inspections when required

Requirements:

• Bachelor’s degree in Science or equivalent with 5 + years’ experience in a GMP audit role within the Biotech/Pharmaceutical Industry is essential
• Good understanding of GMP auditing technical concepts.
• Knowledge of FDA and EMEA international quality systems and regulations required
• Knowledge of pharmaceutical and biotechnology  processes and auditing standards
• Excellent communications and interpersonal skills
• Good organisational and problem-solving skills
• Flexibility to travel regularly
• Fluent in both the English and Chinese

Remuneration: $ Excellent DOE plus benefits

For more information, or to apply, call Diarmuid on +86 21 6157 4981 / email your application below.

Alternatively, you can register your CV directly to our database:

The post GMP Auditor | Shanghai appeared first on Adroit People.

Our client is a leading medical devices multinational with operations globally. Due to continued growth an opportunity has arisen for an experienced NPI Engineer to help drive process efficiencies supporting day to day production through the design, development and introduction of robust process solutions.

This is an excellent opportunity for an accomplished and highly capable NPI Engineer to play a key role in the growth and development of our clients’ Asia presence.

Responsibilities:

• Identify, develop and implement process solutions to support the introduction and ongoing support for new products into full scale manufacturing.
• Provide support to yield, quality and throughput issues as well as provide solutions to identified manufacturing problems with particular reference to scale-up and day-to-day running of processes.
• Identify and source suppliers for parts and equipment, including third party experts to develop specific process elements.
• Select and evaluate equipment, develop jigs & fixtures to support NPI processes, and create supporting documentation – including V&V documentation.
• Review product, process and equipment designs to ensure they meet NPI requirements with regard to execution time, maintainability, OH&S, reliability and are adequately documented.
• Innovate and develop experiments and challenge processes giving due consideration to variation inputs.
• Work with R&D groups to ensure work instructions result in the manufacture of products compliant with corporate and regulatory quality standards.
• Establish projects to maximise production efficiencies on new and existing manufacturing processes with particular regard to Lean Manufacturing.

Requirements:

• B.Eng. Mechanical/Mechatronic or relevant Engineering discipline, plus 5 years’ experience in a similar process design role within a highly regulated industry – electronics, defence, medical technologies, semi-conductors.
• Proven track record in process design and development from concept stage – ESSENTIAL.
• Process validation experience, and exposure to project management principles
• Demonstrated experience in the successful development and/or deployment of Lean Manufacturing/Six Sigma programs within similar environments would be highly advantageous.
• Strong knowledge of ISO quality systems – ISO9001, ISO14000, ISO13485 (ideally).
• Superior written and verbal communication skills.

Remuneration: $ Excellent DOE plus benefits

For more information or to apply call Diarmuid on +612 80960060 / email dsexton@adroitpeople.com.au

Alternatively, you can register your CV directly to our database:

The post NPI Engineer | Singapore appeared first on Adroit People.

Our client is a leading pharmaceutical multinational with operations globally. Due to continued growth within the Asia market our client is currently seeking an experienced Market Access Specialist to join its Taiwan affiliate. In this role you will be responsible for supporting the delivering of key marketing initiatives.

This is an excellent opportunity for the right candidate to contribute their knowledge, experience and skills, contributing to our client’s Asia presence and growth.

Responsibilities:

• Support sales team through sales support tools and samples
• Liaise with regulatory bodies for the implementation of new clinical trial methods
• Investigate market activities and operations
• Resolve sales force, customer and distributor queries
• Build, maintain and develop new customer relationships
• Coordinate with the Europe and US offices regarding new project development to ensure successful implementation
• Build knowledge of the pharmaceutical industry and quality control requirements

Requirements:

• Bachelor degree in science or equivalent with 2-5 years’ experience in a similar Market Access or Health Economics role within the pharmaceutical industry is essential
• Ability to travel frequently as required is essential
• Excellent communication and interpersonal skills
• Ability to work within a team environment and independently
• Strong organisational skills
• Advanced Microsoft suite experience
• Fluent in both English and Mandarin preferred

Remuneration:

$ Excellent DOE plus benefits

For more information, or to apply, call Diarmuid on +86 21 6157 4981 / email your application below.

Alternatively, you can register your CV directly to our database:

The post Market Access Specialist | Taiwan appeared first on Adroit People.

Our client is a leading medical devices multinational with operations globally. Building on growth in Asia, our client is looking to establish its China operations and appoint a Head of Sales based in Shanghai. This is a critical leadership role responsible for the establishment and building of the China operations and distributor networks within the region.

This is an excellent opportunity for an accomplished and highly capable Sales/Commercial Manager to play a key role in the growth and development of our client’s Asia presence.

Responsibilities

• Gather market and customer information on trends to support sales campaigns
• Assess and develop distributor network and sales channels for current and pipeline products.
• Work closely with operation teams to ensure successful delivery of client services – product development and OEM supply
• Ensure quality control of all sales output pertaining to customer acquisition and service delivery within distributor channels
• Establish and monitor performance reporting systems
• Engage and propose the development of new marketing propositions
• Manage, engage and influence VP level accounts/clients
• Drive sales for finished products, designs and component services
• Implement and drive best practice for sales management and reporting tool

Requirements:

• Bachelor degree in business or MBA is advantageous with a minimum of 8-15 years’ experience in commercial sales within the medical technologies industry
• Proven track record of driving sales teams and exceeding revenue targets
• Exposure or experience in the medical devices, outsourcing or clinical sales
• Effective negotiation and problem solving skills
• Ability to work in a complex environment
• Excellent communication and analytical skills
• Advanced knowledge and experience in Microsoft suite
• Highly self-motivated, ambitious and goal orientated
• Ability to work independently and within a team environment
• Experience in implementing and driving world class best practice sales management and reporting tools
• Fluent in both English and Chinese preferred

Remuneration:

Salary: ¥Excellent Package + Benefits + Bonus + More…

For more information or to apply call Diarmuid on +612 80960060 / email dsexton@adroitpeople.com.au

Alternatively, you can register your CV directly to our database:

The post Head of Sales | Medical Devices | Shanghai appeared first on Adroit People.

Our client is a leading provider of services to the life sciences industry and operates across the EU and Asia.  Due to continued growth and dominance in their markets, a new opportunity exists for a Senior Bio Process Engineer in China. As a Senior Bio Process Engineer you will play a key role in the design and delivery of full turnkey solutions.

This is an excellent opportunity for the right candidate to contribute their knowledge, experience and skills in a large global organisation with an enviable client list.

Responsibilities:

• Technical procurement support for process equipment
• Lead mechanical design process from concept through to documentation phases of all projects
• Process design and execution of chemical, API, primary, secondary pharmaceutical and biotech facility projects
• Liaise with clients and key stakeholders in preparing and executing tenders and prices for projects
• Oversee construction sequence and process equipment installations
• Review and approve construction method statements
• Troubleshoot technical issues
• Design, optimize and specify new process equipment
• Qualify process equipment according to regulatory standards
• Select process equipment and determine critical process parameters relevant for design of production process or scale-up

Requirements:

• Relevant tertiary qualification with at least 10 years’ experience in front end process design in pharmaceutical or biotechnology environments
• Demonstrated experience in coordinating project activities
• Strong interpersonal skills
• Excellent problem solving and troubleshooting skills
• Advanced Microsoft Suite experience
• Proven organisational skills
• Excellent oral and written communication skills
• Fluent in Chinese (Mandarin required, Cantonese optional), and English languages
• Preferable recent experience working for a Western business organisation including travel outside of Asia in project scheduling and project engineering.

Remuneration:

Salary: $ Excellent and benefits.

For more information, or to apply, contact Diarmuid on +612 8096 0060 / email your application below.

Alternatively, you can register your CV directly to our database:

The post Senior Bio Process Engineer | Shanghai appeared first on Adroit People.

Our client is a highly successful consumer technologies innovator with operations on a global scale. Sustained record growth over the past decade has led to increased market share and exposure to new markets.

To support this growth a new opportunity has been created for a Quality Manager to join our client’s Singapore based operations in ensuring the highest commitment to quality systems, regulatory compliance and product quality.

Responsibilities:

• Design, develop and maintain quality assurance management plans across all areas of the business
• Effectively interact with developmental teams to maintain product supply and help in the introduction of new products
• Ensure compliance with national and international standards and legislations
• Develop and manage quality assurance metrics for performance improvement of all teams
• Develop standards, methods or procedures to determine product quality or release readiness
• Evaluate and enhance quality assurance standards, technologies and approaches
• Facilities in process risk assessments (e.g. validation protocols and other reports)
• Establish specifications and procedures
• Implement ongoing quality improvement processes across all areas
• Identify deviance from standards, and suggest modifications to ensure compliance
• Develop and monitor quality budgets and spending
• Interface with regulatory agencies and manage regulatory audits as required ( FDA, ISO, PMDA, International)
• Manage Quality Engineers, lab lead, lab tech and other technical quality functions to support manufacturing and development programs.

Requirements:

• Bachelor of Science or Engineering  with a minimum of 10 years practical experience in the pharmaceutical  or medical technologies industry ideally in clinical research, QA/ QC/ technical/ manufacturing
• Knowledge and experience with FDA, Medsafe , ISO 9001 and 13485
• Sound working knowledge of Australian Gxps (i.e. GWP, GMP, GDP, GCP) related to Medicines in Schedules 2,3,4 and 8 and medical devices
• Excellent verbal and written communication skills
• Knowledge of risk management, design control, process validation, inspection and auditing
• ASQ Quality Engineer, Quality Manager and/ or Six Sigma Black Belt certification desirable
• Involvement and/or understanding of state DPCP requirements, samples distribution and clinical trials beneficial
• Strong analytical and problem solving skills

Remuneration:

Salary: $ Excellent plus benefits & bonuses

For more information, or to apply, call Diarmuid on +612 8096 0060 / email your application below.

Alternatively, you can register your CV directly to our database:

The post Quality Manager | Singapore appeared first on Adroit People.

Due to continued growth and internal progression an opportunity has arisen for an experienced Senior QA Engineer to join the manufacturing group and help drive continuous improvement projects that guide the resolution of cross functional issues and create a new focus for the wider organisation in the transition to a culture of continuous improvement.

This is an outstanding opportunity to work with a global leader in medical technology development at a critical stage of their growth and will suit accomplished professionals seeking to further their career in a dynamic and rewarding work environment.

Responsibilities:

• Participate in and lead business process improvement projects that require a high level of technical/process analysis skills, and strong understanding of systems interrelationships (inc. cause and effect) for product development and manufacturing processes.
• Ensure that all CAPAs and investigations and reports meet the requirements of the business quality system and external authorities (ISO, CE, FDA etc).
• Identify, implement and lead CI initiatives and programs that deliver positive impacts to manufacturing efficiencies, QA and compliance.
• Assist CI Champions to manage their achievements and use the Continuous Improvement philosophy to bring about positive change.

Requirements:

• Bachelor of Science or Engineering with 3-5 years experience in a problem solving/analysis role as evidenced by a combination of formal education/training and experience.
• Proven track record in identifying and implementing CI programs that deliver effective results
• Demonstrable project management skills and track record in the completion of multiple projects within scope, timeline and budget.
• Demonstrated experience in resolving CAPA issues beyond line quality assurance, addressing systemic issues in the product development and manufacturing process.
• Superior verbal and written communication skills with the ability to present ideas to all levels of the organization that ensure the successful take up and execution of CI initiatives.

Remuneration:

$ Excellent DOE plus benefits

For more information, or to apply, call Diarmuid on 02-80960060 / email your application below.

Alternatively, you can register your CV directly to our database:

The post Senior QA Engineer appeared first on Adroit People.

Due to continued growth and internal progression an opportunity has arisen for an experienced Supplier QA Manager to join our client’s global supplier team.  In this role you will develop and support supplier performances.

This is an outstanding opportunity to work with a global leader in medical technology development in a critical stage of their growth and will suit accomplished professionals seeking to further their career in a dynamic and rewarding work environment.

Responsibilities:

• Participate and facilitate risk assessments and reduction strategies of suppliers
• Liaise with suppliers to mitigate risk and opportunities
• Coordinate and assist in supplier training in continuous improvement with application of six sigma lean tools and methodologies
• Maintain technical awareness and skills regarding continuous improvement initiatives.
• Conduct supplier audits and non-conformance resolutions
• Promote supplier improvement and develop supplier management plans and processes
• Established quality control policies whilst ensuring all regulatory requirements are adhered to
• Maintain supplier relationships and coordinate global supplier alliances
• Regularly manage supplier manuals

Requirements:

• Bachelor of Engineering or equivalent with a minimum of 8 years practical experience in supplier quality engineering within the medical devices, manufacturing or pharmaceutical industries
• Demonstrated experience in coordinating project activities
• Strong organisational skills and great attention to detail with the ability to work towards deadlines in a timely and efficient manner
• Excellent communication and interpersonal skills
• Ability to work independently and within a team environment
• Advanced Microsoft Suite skills
• Excellent problem solving skills

Remuneration:

Salary: $ Excellent and benefits.

For more information, or to apply, contact Diarmuid on +612 8096 0060 / email your application below.

Alternatively, you can register your CV directly to our database:

The post Supplier QA Engineer | 7 Month Contract appeared first on Adroit People.