Senior Scientific Officer

3 weeks ago

Dera Bassi, India Panacea Biotec Full time

Position Title : Senior Scientific Officer/Scientific Officer-Quality Assurance -Validation

Educational Qualification : M.Sc. - Microbiology/Biotechnology, B.Tech- Biotechnology,

Experience : 3 to 7 years


Job Summary:

Senior Scientific Officer- Validation (QA) shall be responsible for ensuring the quality and efficacy of vaccine Drug Substance Plant, Lalru (Punjab). This position will be responsible for overseeing the Qualification/ validation of various Equipment/ System i.e. HVAC Filling line, Autoclave, Tunnel, Fermenters, DHS, refrigerators, Process tanks etc.


1. Preparation and Review of SOPs/Protocols

  • Develop and review Standard Operating Procedures (SOPs) and validation protocols related to equipment, systems, and facilities.
  • Conduct training sessions for relevant personnel on validation processes and compliance standards.

2. Validation of Systems and Equipment

  • Execute and review validation activities for:
  • HVAC systems : Air handling units, cleanroom validations.
  • Water systems : Purified water, WFI (Water for Injection), and distribution systems.
  • Equipment: Autoclaves, DHS (Dry Heat Sterilizer), refrigerators, cold rooms, deep-freezers, fermenters, process tanks, garment washing machines , and more.

3. Process and Cleaning Validation

  • Plan, execute, monitor, and review:
  • Process Validation : Ensuring consistent and reproducible manufacturing outcomes.
  • Cleaning Validation : Establishing and verifying cleaning procedures to prevent cross-contamination.

4. Equipment Qualification (URS, DQ, IQ, OQ, PQ)

  • Manage User Requirement Specifications (URS) , Design Qualification (DQ) , Installation Qualification (IQ) , Operational Qualification (OQ) , and Performance Qualification (PQ) .
  • Review qualification protocols and results to ensure compliance with GMP requirements.

5. Validation Planner and Coordination

  • Prepare and review a Validation Master Plan (VMP) and validation planner.
  • Coordinate with cross-functional teams (CFTs) for smooth execution of validation activities.

6. Revalidation and Calibration

  • Periodically review validation and revalidation data for equipment and systems.
  • Monitor calibration plans and review calibration certificates to ensure adherence to standards.

7. Risk Assessment and Methodologies

  • Apply risk assessment concepts and methodologies (e.g., FMEA, HACCP) to validation processes and ensure a risk-based approach to compliance.

8. Documentation and Compliance

  • Ensure proper documentation and review for all validation and qualification activities as per GLP (Good Laboratory Practices) and GDP (Good Documentation Practices) standards.


Competencies Required

  • Aseptic Behavior: Demonstrate and enforce proper aseptic techniques and practices in validation and operations.
  • Cross-Functional Coordination: Collaborate effectively with cross-functional teams (e.g., QA, Production, Maintenance, and R&D) to ensure timely execution and closure of validation activities.
  • Data Integrity: Strong understanding and adherence to Data Integrity Principles, ensuring accuracy, completeness, and traceability of validation data.
  • Timely Execution: Proactively follow up and ensure timely closure of validation activities, deviation investigations, and change controls.
  • Compliance Adherence
  • Ensure strict adherence to:
  • GLP (Good Laboratory Practices)
  • GDP (Good Documentation Practices)
  • Plant compliance standards and regulatory requirements.
  • Detail-oriented with strong analytical and problem-solving skills.
  • Strong communication and coordination abilities to manage cross-departmental collaborations.
  • Ability to manage multiple validation projects and prioritize tasks effectively.
  • In-depth knowledge of pharmaceutical regulatory guidelines.

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