Compliance Manager (Steriles)

Tasks overview: To manage and execute assigned change projects (including technical changes, transfers, divestment, pruning and due diligence activities) from initiation to execution, in order to ensure timely supply to the markets in compliance with regulatory and cGMP requirements as well as internal quality standards. Review and approve GMP documents associated with those change projects. This role requires adherence to specific cGMP requirements and execution according to the valid SOP’s. As Site Change Manager, you will manage Change Projects:

• Lead the on-site and inter-functional evaluation and implementation phases of change requests, considering the most effective implementation strategy, priorities, cGMP’s, regulatory requirements, company policies and cost effectiveness.
• Establish and lead on site project teams in order to ensure project management according to the agreed strategy and timelines, including ensuring efficient, timely and clear communication to all involved partners (on-site and off-site incl. to global product lifecycle leader and DRA REG CMC) as required.
• Communicate project progress and deviations as appropriate and elaborate risk mitigation plans as appropriate.
• Ensure timely delivery of complete and consistent source data to DRA REG CMC. Co-ordinate and provide timely review (on-site) of CMC documentation.
• Ensure that projects are realized / implemented without stock-outs.
• Ensure that write-off costs are kept to a minimum.
• Support process experts in evaluation, planning and execution for main and sub processes(e.g. CAR, capacity planning, resources, etc.).
• Review and approve Process Validation Protocols & Reports (Revalidation, Verification, Product Transfers), including associated Risk Assessments and Deviations.
• Review and approve Equipment, Facility and Utilities Qualification Protocols & Reports, including associated Risk Assessments and Deviations.
• Review and approve Cleaning Validation Protocols & Reports, including associated Risk Assessments and Deviations.
• Approve Excipient and Packaging Testing Monographs.
• Compile APRs/PQRs in accordance with GMP requirements, and to ensure that follow-up activities are defined, carried out and reported

What we are looking for:

• Professional experience in quality control/quality assurance or in the manufacturing of pharmaceutical drug products and Steriles/Biotechnology. Profound knowledge in cGMPs.
• University degree preferably in pharmacy or pharmaceutical technology, or chemistry, engineering or equivalent.
• Fluent German, accompanied by good English.

If you want to be part of a dynamic, fast-paced global environment, please do not hesitate to apply today!

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