Quality Assurance Manager (CMO)

Your tasks

We are looking for a Quality Assurance Manager (CMO) for our team in Aachen.

Main tasks:

• Ensure that assigned contract manufacturers of PAION Pharma GmbH, wherever located, comply with EU-GMPs, international guidelines and internal quality standards.
• Support in analytical method transfer projects to new laboratories. Qualifications and validations of analytical methods.
• Support in process technology transfer to new production sites.
• Ensure that the batch documentation is properly controlled for compliance with EU-GMPs and the Marketing Authorization.
• Ensure continuous improvement of assigned quality systems as system owner.
• Cost and safety awareness.

Functional Responsibilities:

• Manage the quality of contract manufactures for assigned products as responsible person, and contribute in the improvement of QMS by providing guidance, advice and training.
• Lead regular GLP and GMP audits at the contractor sites following the yearly audit plan. Prepare audit reports with CAPAs and perform follow up aiming at continual improvement in quality of the audited contractor site
• Responsible for handling deviation, CAPA, laboratory investigation, Customer complaints and GDP incidents.
• Accountable to improve quality management system by performing internal audit, risk assessment and root cause analysis.
• Support QC teams in transfer of technology projects, such as analytical method transfer as well as transfers of production to new sites, as required. Review and approve QC testing methods. Prepare and review Validation and method transfer protocols and reports.
• Evaluate and coordinate product changes according to the PAION Change Control procedures to ensure product / procedural compliance with registration, applicable regulations and business expectations.
• Manage supplier evaluation system, as required as system owner.
• Review annual product reviews (APR) from the manufacturing/packaging/QC-testing contractor sites and edit final PQRs according to PAION procedures.
• Perform review of batch records, i.e. manufacturing and QC documents, to ensure compliance with EU, national and PAION quality standards and requirements and compliance with the Marketing Authorization. Provide QC trend-chart monitoring of analytical results and recommend Certification of release to the designated QP at PAION.

Your profile

• MSc degree in life science, preferably pharmacy, biology or chemistry
• 5 years or more experience in the pharma industry GLP, GMP and GDP environment
• Basic knowledge in Regulatory Affairs
• Fluent in German and English for business proficiency.
• Team Player
• Willingness to travel (EU and Asia)

Why us?

• 30 days vacation
• Short communication channels, open doors and helpful, committed colleagues
• Flexible working hours with partial home office for a good work-life-balance
• State-of-the-art IT equipment with Dell equipment and Apple iPhones
• New office facilities with employee showers for athletes and underground parking spaces in Aachen in a very good location directly on the A44 freeway

PAION contact details

Do you want to work in an international and dynamic environment and would like to play an active role?
We look forward to receiving your application preferably by email, at recruiting@paion.com.
If you have any questions, send an email at HR@paion.com.
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About us

PAION Pharma GmbH, headquartered in Aachen, Germany, is a specialty pharmaceutical company in the field of anaesthesia and critical care specialising in innovative active pharmaceutical ingredients for use in outpatients and hospitals.
PAION Pharma GmbH is part of the Humanwelll Healthcare Group.
www.paionpharma.com