Panacea Biotec Microbiology Job Opening – MSc Biotech Apply Online
Senior Scientific Officer – Sterility Assurance (QA)
Baddi, Himachal Pradesh, India
About the job
JOB SUMMARY:
Senior Scientific Officer – Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behavior during aseptic operations and Media Fill studies. The candidate will review and ensure that the smoke studies have been executed as per the routine aseptic operations. The role involves identifying and communicating improvement scopes to the respective department and HOD at the Vaccine Formulations Plant in Baddi.
RESPONSIBILITIES:
- 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 and Environmental Monitoring
- Ensure Aseptic Core Monitoring and responsible for monitoring aseptic practices and disqualification
- Review media fills, smoke studies, and critical batch operations
- Implement contamination control strategies and management plans for continuous sterility improvements
- Participate in and provide oversight during Aseptic Process Simulation Studies
- Design training modules related to sterility assurance and aseptic practices
- Conduct training on Aseptic Techniques/behaviors with emphasis on aseptic techniques during manufacturing operations, clean-room behavior, etc.
- Support all key investigations related to Sterility Assurance of manufactured products 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
- Oversee the Risk Assessment & Mitigation plan regarding sterility assurance, men and material movement, etc., in production and microbiology sections
- 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, and Media Fill studies
- Experience in handling QMS elements such as deviation, change control, CAPA, incident management, etc.
- Must be able to effectively communicate with large groups and work collaboratively
- Master’s degree in Microbiology, Biotechnology, or a related field
- Minimum 5 years of experience in sterility assurance/microbiology within sterile/vaccine/injectable manufacturing or biotechnology manufacturing environments
Link to Original Notification to apply: Apply Here
Keywords: Panacea Biotec, Senior Scientific Officer, Sterility Assurance, QA, Baddi, Himachal Pradesh, India, Vaccine Formulations, Microbiology, Aseptic Practices, GMP. Panacea Biotec Microbiology Job Opening – MSc Biotech Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
