Deputy Manager – Quality Assurance (Validation)

Hamdard Pakistan is seeking a dedicated Deputy Manager in Quality Assurance focusing on Validation. This pivotal role requires overseeing the full lifecycle of validation activities to ensure that pharmaceutical manufacturing processes, equipment, and analytical methods meet stringent regulatory standards and internal quality benchmarks. The selected candidate will lead a focused team of four professionals, coordinating cross-functional efforts to uphold compliance with Good Manufacturing Practices (GMP), ICH guidelines, and other regulatory requirements. With a minimum of six years of relevant experience, the Deputy Manager will be responsible for developing, implementing, and maintaining the Validation Master Plan, alongside managing validation protocols and reports for various dosage forms within the companys production environment. This leadership position demands strong expertise in validation processes, including Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, and Continued Process Verification. The individual will work collaboratively with departments such as Production, Quality Control, Engineering, and Supply Chain to ensure seamless validation operations. Additional duties include overseeing computerized system validation, monitoring process performance, facilitating regulatory inspections, and driving corrective and preventive actions. The Deputy Manager will provide technical guidance and training to team members, fostering a culture of quality and continuous improvement within the validation function.
Responsibilities
 

• Develop, implement, and maintain the Validation Master Plan to guide validation activities across the company.
• Ensure comprehensive lifecycle validation including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Continued Process Verification (CPV).
• Coordinate validation projects with Production, Quality Control, Engineering, Supply Chain, and other departments to ensure regulatory compliance and process robustness.
• Review, approve, and supervise the execution of validation protocols and reports for solid, semi-solid, and liquid dosage forms.
• Design and execute process validation studies to confirm manufacturing processes consistently produce products meeting quality standards.
• Monitor ongoing process performance through continued process verification and conduct trend analysis to identify areas for improvement.
• Develop, review, and approve cleaning validation protocols, reports, and risk assessments ensuring effective sanitation practices.
• Validate and verify analytical methods in accordance with ICH guidelines and regulatory requirements to maintain data accuracy and reliability.
• Evaluate Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) to assure process consistency and product quality.
• Lead qualification and requalification of manufacturing equipment, utilities, and support systems as per User Requirement Specifications (URS).
• Manage computerized system validation activities, ensuring compliance with data integrity and audit trail requirements within GMP-regulated environments.
• Review electronic records and audit trails for computerized systems to guarantee data accuracy and traceability.
• Support and participate in regulatory inspections, customer audits, and internal audits related to validation to maintain compliance readiness.
• Investigate validation deviations and non-conformances; develop and implement corrective and preventive actions (CAPA) effectively.
• Maintain comprehensive and compliant documentation for all validation activities adhering to GMP and data integrity standards.
• Provide technical leadership, guidance, and training to validation and quality personnel to enhance team capabilities and ensure adherence to quality standards.