Clean Room Compliance Expert

Beschreibung

Clean Room Compliance Expert

The leading pharmaceutical company is seeking a Clean Room compliance expert to support their manufacturing site in Germany.

Job Role Description:
The clean room team want to review the SOPs and associated documentation to align best practice with global SOPs and GMP/FDA requirements. They need the support of an experienced individual, who can advise them on setting up a robust strategy.

• Review current SOP and carry out a gap analysis for clean rooms A-D.
• Carry out change management to align SOPs for clean rooms to global standards including FDA and GMP.
• Review SOPs and qualification/validation strategy for the department to follow ongoing.
• Share knowledge and expertise with other members of the team and train up individuals in the new processes.

Required:
• Extensive experience in the pharmaceutical or medical device industry.
• Outstanding knowledge of clean room compliance requirements for classes A-D.
• Excellent communication skills
• Fluent German language required.

Excellent opportunity to bring your skills and experience gained through your career in the pharmaceutical industry to help support and advise a client in best practice approach.