Compliance Specialist Operations

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Compliance Specialist / Teamlead Operations (m/w) CM&T F2P2

This role is responsible for implementing and ensuring compliance with new regulatory requirements supporting other production team leaders in GMPcompliant manufacturing leading a team that produces clinical products (compounding filling visual inspection and device assembly) and supporting projects within CM&T production.

Responsibilities (summary)

• Support and implement measures to ensure compliance with Annex 1 requirements.

• Lead and schedule a production team in a twoshift operation with responsibility for target achievement and overall performance.

• Ensure ontime delivery of clinical and commercial batches in coordination with global and local planning.

• Ensure EHS GMP and regulatory compliance including audit readiness.

• Manage and execute NPI and operational projects; support qualification and validation activities.

• Contribute to MES/PASX adjustments MBR/ESP management and document maintenance.

• Coach and develop team members and promote continuous improvement (Lean).

• Provide role coverage during absences deputising for other team leads or department management.

Your profile

• Completed vocational training in the pharmaceutical field or a BSc in Pharmaceutical Biochemical Chemical sciences or equivalent.

• Minimum of 2 years experience in a GMP environment.

• Production leadership experience in a twoshift operation; project management experience is an advantage.

• Strong problemsolving skills effective crossfunctional collaboration and clear communication.

• Excellent German and English skills both written and spoken.
  
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