Quality Assurance Manager - Validation

About the role

Hamdard Pakistan is seeking a dedicated Quality Assurance Manager specializing in Validation to join its Karachi team. The role involves developing and executing validation plans to ensure compliance with industry standards and regulatory requirements while leading a small validation team.

Key responsibilities

• Develop, implement, and maintain comprehensive validation plans aligned with company policies and regulatory guidelines.
• Lead and manage a team of two validation professionals, providing training, guidance, and performance evaluations.
• Coordinate and conduct validation activities such as process validation, equipment qualification, and cleaning validation.
• Review and approve validation protocols, summaries, and reports to ensure accuracy and compliance.
• Collaborate with cross‑functional departments to identify validation needs and address compliance issues.
• Monitor and analyze validation data to identify trends and implement corrective actions.
• Ensure all validation documentation is prepared, reviewed, archived according to regulatory standards and support internal and external audits.

Required profile

• Pharm D degree.
• Minimum three years of relevant validation experience in the pharmaceutical industry.
• Proven ability to lead a small team and drive continuous improvement.

Required skills

• Process validation.
• Equipment qualification.
• Cleaning validation.
• Preparation and review of validation protocols and reports.
• Data analysis for validation trends.
• Knowledge of current Good Manufacturing Practices (cGMP) and regulatory requirements.