Officer

Key Responsibilities:

• Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities.
• Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination.
• Perform process validation (PV) activities for new and existing products.
• Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting.
• Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements.
• Ensure calibration and qualification records are up to date and compliant.
• Maintain documentation in compliance with data integrity and ALCOA+ principles.
• Support audits and regulatory inspections by providing validation documentation and clarifications.
• Track and monitor validation schedules and ensure timely completion.
• Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12).

Qualifications:

• B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field.
• 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup.
• Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements.

Key Skills:

• Sound knowledge of validation principles, risk assessment, and lifecycle approach.
• Proficiency in drafting validation protocols and technical documentation.
• Experience with computerized system validation (CSV) is an advantage.
• Good analytical, problem-solving, and organizational skills.
• Effective communication and ability to work in a team.