Do you want to work in a big pharmaceutical company? Do you have at least 4 years experience in QA? You should then read the following lines!
Our client, based in the Basel area, is looking for a CH - Manager 2, Quality Assurance for a 1 year contract.
This position will provide QA technical support for External Manufacturers in a region. Assist in the development of corrective action plans and monitor implementation.
Assist in the development, writing and implementation of quality procedures. Provide QA support for technology transfer and improvement of existing manufacturing processes.
Contribute to the overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products.
Conduct investigations, perform customary audits, collect data, analyze trends, and prepare reports as required.
Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time.
Monitor trends, identify issues, recommend and implement appropriate actions.
Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
Coordinate and provide concurrences on deviations, change controls and CAPAs.
Participate and Lead audits of External Manufacturers.
Assists with regulatory inspections and provides follow up on regulatory commitments.
Develop, implement, and review of SOPs for interactions with External Manufacturers.
Investigate customer product quality complaints.
Apply cGMP regulations and other international requirements to all aspects of the position.
Coordinate change control documentation and approval process.
Provide Quality oversight and participate on technology transfer teams.
Interface with other functions (Operations, Planning, Technical Operations, etc) in the support of External Supply
ADDITIONAL RESPONSIBILITIES / DUTIES :
Providing support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing.
Remaining current with HA and local regulations, guidelines, and quality practices associated with the pharmaceutical
SKILLS and PROFILE
10 years of experience in the manufacturing of Pharmaceuticals products and at least 5 years in QA are mandatory requirements.
University degree (Minimum BA / BS in a scientific discipline)
Familiar with EU GMP
Ideally familiar with Trackwise
Computer literatem, well versed in Microsoft Office tools with the ability to communicate effectively electronically
Continued development of knowledge and expertise as needed in order to perform job duties
Fluent in English (spoken and written - all documentation in English). French would be useful
Do not waste any minutes, apply now! We are looking forward to receiving your application.
Please note that only candidates with a valid work permit or who are EU / EFTA citizens will be considered.