Panacea Biotec Microbiology Position Available – MSc Biotech Apply Now!
Senior Scientific Officer
Location: 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, and for reviewing and ensuring that smoke studies have been executed as per routine aseptic operations. The candidate will be responsible for identifying and communicating the improvement scope to the respective department and HOD at Vaccine Formulations Plant Baddi.
RESPONSIBILITIES:
- Oversight of compliance with respect to Sterility Assurance to ensure alignment with Site, Global, and Regulatory requirements, including but not limited to Aseptic Practices and Environmental Monitoring.
- Ensure Aseptic Core Monitoring and take responsibility 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 and provide oversight during Aseptic Process Simulation Studies.
- Design training modules related to sterility assurance and aseptic practices.
- Conduct training on aseptic techniques and behaviors with an emphasis on clean-room behavior during manufacturing operations.
- Support key investigations related to sterility assurance of manufactured products and adverse environmental trends.
- Provide microbiological and sterility expertise for cGMP documents, including SOPs, batch records, media fill/APS protocols and reports, validations, and specifications.
- Oversee risk assessment and mitigation plans with respect to sterility assurance, including personnel and material movement in production and microbiology sections.
- Conduct risk assessments and implement risk mitigation strategies to minimize microbial contamination risks.
- 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 handling QMS elements such as deviation, change control, CAPA, and incidents.
- Must be able to effectively communicate with large groups and work collaboratively.
QUALIFICATIONS:
- Master’s degree in Microbiology, Biotechnology, or a related field.
- Minimum 5 years of experience in sterility assurance or microbiology within a sterile, vaccine, injectable, or biotechnology manufacturing environment.
Apply here: Link to Original Notification
Keywords: Senior Scientific Officer, Sterility Assurance, Panacea Biotec, Baddi, Himachal Pradesh, India, Microbiology, Biotechnology. Panacea Biotec Microbiology Position Available – MSc Biotech Apply Now! 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
