- We are looking for a QA Engineer expert dedicated to Qualification&Validation Activities covered by ISO13485 and 21CFR820 requirements.
- You will provide expert advice, support and management for technical operational QA and general QA matters for specific vendors on behalf of one of our clients.
- Design & Development management :
Provide expert advice, support and management for technical operational QA and general QA matters for specific vendors, on behalf of the company, in design/development of products and combination products ensuring application of GMP requirements. Specifically focus on the following:
- Oversee Design input-output Validation/Verification activities
- Review and approve protocols and reports for Verification & Validation studies, Technology transfers, and Stability studies
- Ensure risk assessments are performed at appropriate stages of development and for decision making on issues arising
- Oversee inspection plans
- Provide expert support to internal partners to assure systems are in place to manage novel new drug introducer technologies
- Facilitate investigations, and resolution of issues relating to deviation and change management
- Deviation review and approval during Verification, Change Control, Validation and Technology Transfer
- Verification, validation and technology transfer
- Lead/review critical investigations
- Tracking CAPA events and closure
- Overseeing/tracking Design Change Control
- Ensuring application of GMP requirements
- Company's documentation review and approval
- Review and approve submissions and responses
- Review and Approve relevant sections of the device Technical Documentation File as required
- Release of Clinical Trial Medical Devices
- Ensure Design History File is in place
- Accommodate design & technology transfer and ensure systems alignment between vendor and the company
- Performing focused assessments/audits
- Review and Approve Quality Agreements
- Project support :
- Provide expert advice and support on operational and general QA activities to teams working on key projects for the further development of products portfolio
- Act as the Operational QA link between selected external vendors within the Device Development portfolio.
- As required (and in collaboration with the Head of CM&C Development QA) provide Operational QA support to Critical Vendors outside of the Device Development vendor portfolio.
- Assist with regulatory and customer inspections at Vendors. Specifically focus on:
- Inspection preparation
- Support during inspection
- Support post inspection observation closure.
- Work closely with staff in the Corporate QA teams (especially CM&C Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for selected critical vendors are provided in an effective and efficient way.
- Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
- Support additional projects as requested
- Provide on-site presence ‘in plant’ or on site at vendor
- Support Management Review Process
- General GMP :
- Maintain Quality System elements associated with the GMP activities in a compliant manner.
- Drive/Support projects related to quality system improvement.
- Maintain key performance indicators (metrics) for key operational QA activities and services associated with the Device and combination products activities.
- Maintain GMP compliance and inspection/audit readiness at all times. Support Head of Commercial QA in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments.
- Support Device related inspections
- Minimum of 7 years working in the pharmaceutical/biologics/medical device industry in a quality management position.
- Operational GMP experience would be a distinct advantage.
- Practical understanding of ISO13485 and 21CFR820 requirements
- Experience interacting with regulatory bodies and third party organizations with respect to QA systems and regulatory inspection preparedness.
- Medical Device auditing expertise and operational manufacturing/QC experience.
- Must have a US and EU knowledge of pharmaceutical and medical device regulations together with quality principles and techniques.
- Must have Pharmaceutical and Medical Device auditing capabilities and skills.
- Set challenging objectives for self and drive for results using the resources available in an efficient and effective way.
- Take accountability for decisions and actions taken.
- Be proactive, confident and enthusiastic during the interaction with colleagues during team work and take the initiative to promote and share/implement best practices.
- Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental and external meetings. Ensure free flow of information throughout the sphere of work.
- Root cause and risk management/assessment skills will be a distinct advantage
Management & Leadership skills (ability to lead, motivate, inspire, resolve conflict, etc):
- Must be able to coordinate and lead a team to achieve a desired objective or outcome especially when working in a cross-cultural team environment.
- Also needs to be able to share technical competencies through coaching/training team members when appropriate.
- Must be able to effectively interact with internal and external personnel on many aspects of project and product related matters.
- Be confident in providing constructive feedback (and accepting feedback) from work colleagues. Deal proactively with sub performance of self and others.
Others skills appreciated:
- ASQ Certification (CQA, CQE or CQM/OE,) in the US would be an advantage
- Eligibility as a Qualified Person in EU would be an advantage
- English fluent, French is an asset
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.