Role & responsibilities

- Execute equipment qualification activities including DQ, IQ, OQ, and PQ.

- Prepare, review, and maintain qualification and validation protocols and reports.

- Perform qualification of manufacturing equipment, instruments, and utility systems.

- Coordinate qualification activities with Engineering, Production, QC, and external vendors.

- Conduct HVAC, Water System, Compressed Air, and Cleanroom qualification studies.

- Execute process validation, cleaning validation, and hold time studies.

- Prepare and review Validation Master Plans (VMPs).

- Analyze qualification and validation data and prepare summary reports.

- Ensure compliance with cGMP, regulatory requirements, and company procedures.

- Participate in risk assessments related to qualification and validation activities.

- Review and assess validation impact during change control implementation.

- Investigate deviations related to validation activities and support CAPA closure.

- Prepare and revise SOPs related to qualification and validation systems.

- Maintain validation lifecycle documentation and ensure data integrity compliance.





- Plan and execute periodic review and requalification activities.

- Monitor annual validation schedules and ensure timely completion.

- Support internal, customer, and regulatory audits and inspections.

- Coordinate sampling activities for cleaning and process validation studies.

- Ensure proper documentation, archival, and retrieval of validation records.

- Collaborate with cross-functional teams to ensure validated state of facilities, utilities, equipment, and processes.

- Track validation-related KPIs and ensure compliance with established timelines.

- Stay updated with current regulatory expectations and industry best practices related to validation and qualification.

Preferred candidate profile

- 5-10 years of experience in Equipment Qualification/Validation or similar field.

- B.Pharma degree from a recognized institution.

- Robust understanding of pharmaceutical industry regulations and guidelines (e.g., GMP).

- Proficiency in performing various types of validations (IQ/OQ/PQ) using different methods (e.g., wet lab)

📌 Validation Executive (Paonta Sahib)
🏢 Mankind Pharma
📍 Paonta Sahib