Quality Assurance Manager (CMO)

at  PAION Pharma GmbH

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.

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.

YOUR 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:

• Contribute in the improvement of QMS of Contract Manufacturing Organization (CMO) for assigned products.
• Responsible for handling deviation, CAPA, laboratory investigation, Customer complaints and GDP incidents.
• Perform 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.
• 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 and provide trending of results to support Certification of batches, of designated products. Review of raw data and finished product testing documents.