Senior Scientific Officer- Sterility Assurance

2 weeks ago

baddi, India Panacea Biotec Full time

JOB SUMMARY:


Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and communicate the identified improvement scope to respective department and HOD at Vaccine Formulations Plant 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, 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 5 years of experience in sterility assurance/Microbiology within Sterile/Vaccine/Injectable manufacturing or biotechnology manufacturing environment.

  • Senior Scientific Officer

    3 weeks ago

    Baddi, Himachal Pradesh, India Panacea Biotec Full time

    Job SummaryWe are seeking a highly skilled Senior Scientific Officer to join our team at Panacea Biotec. The successful candidate will be responsible for ensuring the highest standards of sterility assurance and aseptic practices in our vaccine formulation processes.Key ResponsibilitiesVerify and ensure compliance with sterility assurance and aseptic...

  • Senior Scientific Officer- Sterility Assurance

    1 week ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY:Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior Scientific Officer- Sterility Assurance

    6 days ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY:Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior scientific officer- sterility assurance

    6 days ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY: Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior scientific officer- sterility assurance

    3 weeks ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY: Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior Scientific Officer- Sterility Assurance

    3 weeks ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY: Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior Scientific Officer- Sterility Assurance

    4 weeks ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY:Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior Scientific Officer- Sterility Assurance

    3 weeks ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY: Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior Scientific Officer- Sterility Assurance

    3 weeks ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY: Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior Scientific Officer- Sterility Assurance

    2 days ago

    baddi, India Panacea Biotec Full time

    JOB SUMMARY: Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior Scientific Officer- Sterility Assurance

    4 weeks ago

    baddi, India Panacea Biotec Full time

    JOB SUMMARY:Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior Scientific Officer- Sterility Assurance

    4 weeks ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY:Senior Scientifc Officer- Sterility Assurance (QA) shall be responsible for verifying and ensuring appropriate aseptic practices & behaviour during aseptic operations & Media Fill studies, and to review and ensure that the smoke studies have been executed as per the routine aseptic operations. Candidate shall be responsible for identify and...

  • Senior Scientific Officer

    3 weeks ago

    Baddi, Himachal Pradesh, India Panacea Biotec Full time

    Job SummaryWe are seeking a highly skilled Senior Scientific Officer to join our team at Panacea Biotec. As a Senior Scientific Officer - Validation, you will be responsible for ensuring the quality and efficacy of our vaccine formulations.Key ResponsibilitiesDevelop and execute validation plans to ensure compliance with regulatory requirements and company...

  • Senior Scientific Officer

    3 weeks ago

    Baddi, Himachal Pradesh, India Panacea Biotec Full time

    Job Summary:As a Senior Scientific Officer - Validation, you will play a critical role in ensuring the quality and efficacy of vaccine formulations at our Baddi facility. This position will oversee the qualification/validation of various equipment/systems, including HVAC, filling lines, autoclaves, and utility systems.Key Responsibilities:Oversee the...

  • Senior Scientific Officer

    1 week ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY:Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine formulations (Vaccine Drug Product Plant,Baddi). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System like HVACFilling line, Autoclave, Tunnel, Utilitiy systems,...

  • Senior scientific officer

    6 days ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY: Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine formulations (Vaccine Drug Product Plant, Baddi). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System like HVACFilling line, Autoclave, Tunnel, Utilitiy systems, etc....

  • Senior Scientific Officer

    3 weeks ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY: Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine formulations (Vaccine Drug Product Plant,Baddi). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System like HVACFilling line, Autoclave, Tunnel, Utilitiy systems, etc. ...

  • Senior Scientific Officer

    6 days ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY:Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine formulations (Vaccine Drug Product Plant,Baddi). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System like HVACFilling line, Autoclave, Tunnel, Utilitiy systems,...

  • Senior Scientific Officer

    4 weeks ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY:Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine formulations (Vaccine Drug Product Plant,Baddi). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System like HVACFilling line, Autoclave, Tunnel, Utilitiy systems,...

  • Senior Scientific Officer

    4 weeks ago

    Baddi, India Panacea Biotec Full time

    JOB SUMMARY:Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine formulations (Vaccine Drug Product Plant,Baddi). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System like HVACFilling line, Autoclave, Tunnel, Utilitiy systems,...