Validation and QMS Specialist

18 hours ago

Ahmedabad, Gujarat, India fe05d514-8c15-4270-ab77-3b33ea19a52e Full time ₹ 15,00,000 - ₹ 30,00,000 per year

Key Responsibility:

Validation Activities:

  1. Media Fill Studies:

  2. Plan, execute, and review media fill trials to ensure aseptic process integrity.

  3. Analyze results and recommend corrective actions when necessary.

  4. Area Qualification:

  5. Oversee qualification of classified manufacturing areas (Grade A-D).

  6. Perform routine re-qualifications and environmental monitoring to ensure regulatory compliance.

  7. Equipment Qualification:

  8. Develop and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of manufacturing equipment.

  9. Review and approve qualification documents.

  10. Utility Qualification:

  11. Validate critical utilities such as HVAC, water systems (WFI), and compressed air systems.

  12. Ensure utilities meet cGMP standards and regulatory guidelines.

  13. Cleaning Validation:

  14. Establish and validate cleaning procedures for equipment and manufacturing areas.

  15. Review cleaning validation protocols and reports to ensure compliance with regulatory requirements.

  16. Process Validation:

  17. Perform process validation studies, including preparation of protocols, execution, and reporting.

  18. Assess process robustness and capability to ensure consistency in product quality.

Quality Management System (QMS):

  1. Change Control:

  2. Review and approve change control proposals.

  3. Assess the impact of changes on validation and regulatory compliance.

  4. Deviation Management:

  5. Investigate deviations, identify root causes, and implement corrective actions.

  6. Document and trend deviations to monitor quality improvements.

  7. CAPA (Corrective and Preventive Action):

  8. Develop and implement CAPAs for identified issues.

  9. Track and verify CAPA effectiveness within the specified timeline.

  10. Out-of-Specification (OOS) and Investigations:

  11. Manage OOS, OOT and conduct thorough investigations, and prepare investigation reports.

  12. Implement corrective actions to prevent recurrence.

  13. Regulatory Compliance:

  14. Ensure adherence to cGMP, US FDA and other regulatory requirements.

  15. Participate in internal and external audits and inspections.

Mandatory Requirements:

  • Valid B1/B2 Visa for the USA.
  • Willingness to travel for work, including international travel to the USA and other regions as required.
  • Have to work as per US timings when working remotely.

Key Skills and Competencies:

  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.
  • Proficiency in QMS tools and software.

Education and Qualifications:

  • Bachelors/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

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