Compliance Specialist (m/w/d)

Compliance Specialist | Penzberg, Germany | Hybrid

We're hiring on behalf of a prominent player in the pharmaceutical industry, recognized for its commitment to innovation and high-quality standards. This organization fosters a collaborative environment where individual contributions are valued and professional growth is actively encouraged.

The Role

• Support group leader and other management in Quality & Compliance matters.
• Conduct internal batch record reviews in coordination with product-responsible group leaders.
• Perform risk-based assessments of produced batches, coordinating root cause analysis and action tracking for deviations.
• Maintain the internal release system (SAP-based) for digital archiving of all produced batches.
• Develop SOPs, directive documents, and deviation reports in collaboration with relevant stakeholders.
• Coordinate, process, and update internal manufacturing instructions.
• Ensure correct filing and archiving of records and documents according to current regulations.
• Manage and update change requests for equipment, coordinating necessary actions.
• Review hygiene measures and track actions related to monitoring limit exceedances.

What You'll Need

• Completed science degree, preferably a Master's in Chemistry.
• Ideally, professional experience in the pharmaceutical or chemical industry.
• Understanding of production, quality control, and business practices within regulated industries.
• Knowledge of relevant DIN ISO standards (13485, 9001) and regulations such as GMP, IVDD, FDA QSReg.
• Experience in process analysis, qualification, and validation.
• Fluent German and good written and spoken English skills.

What's On Offer

• Competitive salary package including Christmas and holiday bonuses.
• Company pension scheme contribution after the probationary period.
• Up to 30 days of annual leave.
• Continuous professional development through e-learning opportunities.
• Support in defining career goals.

Apply via Haystack today!