Beschreibung
Aseptic Process Subject Matter ExpertStart: ASAP
Duration: 6-12 months
Location: Central Germany
A leading pharmaceutical company is seeking a number of experts with Aseptic Process/Sterile manufacturing experience to support their ongoing systematic review of their manufacturing units in Germany.
Job Role Description:
The subject matter experts will review the SOPs and associated documentation to align best practice with global SOPs and GMP/FDA requirements - according to their specific expertise. They require the support of experienced individuals who can advise them on setting up a robust strategy.
Main areas of focus:
HVAC - Environmental Monitoring
Sterile Filtration - Process Review
Clean Rooms A/B
Gowning Procedures
Qualification/Validation of existing equipment - Isolators, Reactors, Autoclaves, Heat Exchangers etc.
Tasks:
Review current SOP and carry out a gap analysis.
Carry out change management to align SOPs for the SME's specific focus area.
Write SOPs and qualification/validation strategy for the department.
Share knowledge and expertise with other members of the team and train up individuals in the new processes.
Carry out GAP analysis and risk assessments.
Lead internal investigations as to whether procedures are being followed by staff.
Required:
Extensive experience in the pharmaceutical or medical device industry.
Outstanding knowledge of Aseptic Processes/Manufacturing.
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.
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.