Senior Scientific Officer

3 weeks ago

Dera Bassi, India Panacea Biotec Full time

Position Title : Senior Scientific Officer/Scientific Officer-Quality Control -Microbiology

Educational Qualification : M.Sc. - Microbiology/Biotechnology

Experience : 3 to 7 years


Job Summary:

Senior Scientific Officer/Scientific Officer, Quality Control-Microbiology shall be responsible for ensuring the quality and efficacy of vaccine formulations at Vaccine Drug Substance Plant, Lalru (Punjab). This position will be responsible for overseeing the operation Microbiological Testing, Perform routine environmental monitoring, Analyze EM data to identify trends, Conduct sterility tests on raw materials, Receive ARM (Analytical Reference Material), Proficiency in ELISA and Western Blotting techniques, Expertise in Bacterial Endotoxin Testing, Familiarity with QMS (Quality Management System) processes etc.

Responsibilities:

Microbiological Testing:

  • Perform routine environmental monitoring (EM) of production areas, including air sampling, surface monitoring, and personnel monitoring.
  • Analyze EM data to identify trends and assess cleanliness levels.
  • Conduct sterility tests on raw materials, intermediates, and final vaccine products to ensure they are free of microbial contamination.
  • Receive ARM (Analytical Reference Material) and other production samples and maintain their respective logs.
  • Monitor and record relative humidity (RH), temperature, and differential pressure in the microbiology lab.
  • Perform activities related to Analytical method validations and ensure accurate record maintenance.
  • Execute qualifications and validations of laboratory equipment.

Compliance and Documentation:

  • Follow SOPs and protocols for all microbiological tests and ensure they are updated as per regulatory guidelines.
  • Prepare and review product specifications and standard test procedures.
  • Maintain accurate, thorough, and compliant documentation of test results and observations.
  • File and document deviations, incidents, and OOS (Out of Specification), OOL (Out of Limit), or OOT (Out of Trend) events.
  • Prepare and review laboratory records, test reports, and Certificates of Analysis (COAs).
  • Review logs related to media preparation, environmental monitoring, critical utilities testing, in-process testing, and other microbiology lab activities.
  • Issue Batch Releasing Certificates for environmental and critical utilities systems for batches manufactured.

Inventory and Equipment Maintenance:

  • Manage lab inventory and ensure availability of necessary materials.
  • Ensure the cleanliness and smooth functioning of all laboratory equipment.

Competencies Required:

Technical Skills:

  • Proficiency in ELISA and Western Blotting techniques.
  • Expertise in Bacterial Endotoxin Testing.
  • Familiarity with QMS (Quality Management System) processes.

Equipment Handling:

  • Skilled in operating laboratory instruments, including:
  • Spectrophotometers
  • Auto pipettes
  • pH meters
  • Incubators

Process and Analytical Knowledge:

  • Sound understanding of microbiological processes and testing procedures.
  • Ability to handle deviations, incidents, and non-conformance reporting effectively.

Attention to Detail:

  • Strong analytical and documentation skills for maintaining logs, records, and compliance reports.

Teamwork and Communication:

Ability to collaborate with cross-functional teams and report findings clearly and accurately.

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