Quality Assurance Manager
About the company:
Our client is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceuticals Drug Products (DP) and packaging capabilities.
They employ over 2000 employees around the world. Their services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Their network in Europe and the US offers flexible and specialized solutions across a range of technology platforms. They strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
They are seeking a Quality Assurance Manager, their job will be:
- Developing and implementing a Quality System based on Business process approach
- Providing collaboration and participation in projects as Quality Representative for equipment / systems validation / qualification.
- Contributing to continuous improvement initiatives (including Operational Excellence)
- Managing people in the Quality Compliance Unit
Additionally the role has the following main duties and responsibilities:
- Provide quality guidance for the development of the validation approach
- Actively contribute to continuous improvement initiatives (including Operational Excellence)
- Act as point of contact in case of customer/supplier/subcontractor/Authorities audit
- Perform inspections/internal audits and provide quality oversight for the inspection/ audit program
- Write Procedures and Policies in accordance with the cGMP and Corden Pharma Policies
- Ensure the review/approval of documentation is timely performed to achieve compliance to procedures and regulatory requirements
- Provide QA support (deviation, CC, CAPA,..)
- Back-up of the Quality Affairs Director for compliance related topics and management of qualification, for cause, or routine audits, visits, inspections customer/supplier/subcontractor/health authorities communications
Qualifications and skills:
- Master degree in Sciences
- 8 years in a QA position
- Knowledge of cGMP in a regulated environment (ICH guidelines)
- Knowledge of quality systems in cGMP environment (21 CFR part 11)
- Excellent accuracy and attention to detail
- Excellent interpersonal skills (Team spirit, Open for the constructive discussion,…)
- Working knowledge of MS office packages (Word, Excel, Power Point) and
- TrackWise® System is in asset
- Strong problems solving skills, issue resolution and root cause analysis
- Knowledge in Lean Tools is an asset
- Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
- Language: French, English
What they offer:
Our client offers a permanent contract, a competitive salary package and varied and motivating responsibilities.
On this occasion LiCa Scientific is acting as an employment agency.