At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring an Interim Microbiology Manager.
Position Type:
Required
- Minimum 10 years of experience in pharmaceutical microbiology, including at least 5 years in a leadership or laboratory management role.
- Strong experience managing a GMP microbiology laboratory.
- Previous experience in sterile or aseptic drug product manufacturing.
- Hands-on knowledge of environmental monitoring, bioburden, endotoxin, and sterility testing.
- Experience managing laboratory analysts, workloads, testing priorities, and operational timelines.
- Strong knowledge of EU GMP Annex 1, contamination control, aseptic processing, and microbiological controls.
- Experience with deviations, OOS investigations, CAPAs, change controls, and inspection readiness.
- Ability to work independently at manager level and start with minimal onboarding.
- Fluent English and strong communication and leadership skills.
Responsibilities:
- Manage daily microbiology laboratory operations and laboratory personnel.
- Oversee environmental monitoring activities.
- Ensure timely execution and review of bioburden, endotoxin, and sterility testing.
- Manage laboratory priorities, workload, staffing, and testing timelines.
- Review and support deviations, OOS results, investigations, CAPAs, and change controls.
- Ensure compliance with GMP, Good Documentation Practices, data integrity requirements, and internal procedures.
- Support inspection readiness and collaborate with Quality, Manufacturing, Validation, and Engineering teams.
- Identify operational and compliance gaps and implement appropriate corrective actions.
- Ensure analysts are properly trained and qualified to perform assigned activities.
Get in Touch:
We want to hear from you! If you think you’d be a good match, submit your resume and reach out to Priyanshu at (201) 478-6913 to learn more.
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