Head - Validation - Pharmaceutical Firm

Designation: Validation Head

Qualification: B. Pharm/ M, Pharm/ M.Sc

Responsibilities:

- He or she should be experienced in Equipment Qualification, HVAC, Utility qualification for Sterile drug products.

- Should have good experience in media fills and spoke studies.

- He or she should have faced the USFDA for sterile injection facility.

- Oversight on execution of validation activity is carrying out as per the annual validation and revalidation planner as per Validation Master Plan.

- Responsible for the harmonization of the equipment/ utilities validation procedures to across the Eugia manufacturing sites as per its design and intended use.

- Responsible for preparing required corporate procedures for equipment and utility qualification.

- Responsible for reviewing the site qualification document, like URS, DQ, IQ, OQ, PQ and

Requalification of direct impact system.

- Good management, communication, and conflict management skills.

- Well versed with regulatory requirement and qualification requirement.

- Well versed with Sterility assurance and contamination control strategy.