Description
The leading pharmaceutical company is seeking a Clean Utilities compliance expert to support their manufacturing units in Germany.Job Role Description:
The clean utilities 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 utilities.
• Carry out change management to align SOPs for clean utilities including steam, compressed air, nitrogen, WFi and clean water.
• Set 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 utilities including steam, compressed air, nitrogen, WFi and clean water.
• Change management experience in a complex manufacturing environment.
• Ability to write and execute SOP training for other department members.
• Excellent communicator with ability to be authoritative.
.• Fluent English language and German language desired.
This is an 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.