Panacea Biotec | MANAGER-STERILITY ASSURANCE
2 weeks ago
Oversight of compliance with respect to Sterility Assurance to ensure alignment to the Site, Global and Regulatory requirements, including but not limited to: Aseptic Practices, Environmental Monitor.
Ensure Aseptic Core Monitoring and responsible for monitoring of aseptic practices and disqualification.
Review of media fills, smoke studies, and critical batch operations.
To implement Contamination control strategies and management plan for continuous Sterility improvements.
Participation and overview during Aseptic process Simulation Studies.
Design training modules related to sterility assurance and aseptic practices.
Impart trainings on Aseptic Techniques/behaviors with emphasis on aseptic techniques during manufacturing operations, clean-room behavior etc.
Support in all key Investigations related to Sterility Assurance of manufactured Product and adverse environmental trends.
Provide microbiological and sterility expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations and specifications.
Oversees in performing the Risk Assessment & Mitigation plan with respect to sterility assurance, men and material movement etc. in production and microbiology section.
Conduct risk assessments and implement risk mitigation strategies to minimize the risk of microbial contamination.
Develop, implement, and maintain comprehensive sterility assurance programs aligned with regulatory requirements (e.g., GMP, FDA, WHO).
SPECIFIC JOB KNOWLEDGE, SKILLS AND ABILITIES
Strong understanding of vaccine formulation processes, regulatory requirements, aseptic practices & Media Fill studies.
Must have experience to handle the QMS element i.e. deviation, change control, CAPA, incident etc.
Must be able to effectively communicate with large groups and work collaboratively.
Master's degree in Microbiology, Biotechnology, or a related field.
Minimum 10 years of experience in sterility assurance/Microbiology within Sterile/Vaccine/Injectable manufacturing or biotechnology manufacturing environment.
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