Overview
Deputy Manager – Quality Assurance (Validation) Jobs in Karachi Division, Sindh, Pakistan at Hamdard Pakistan
Title: Deputy Manager – Quality Assurance (Validation)
Company: Hamdard Pakistan
Location: Karachi Division, Sindh, Pakistan
Hamdard Pakistan is hiring a Deputy Manager – Quality Assurance (Validation)
Location: Karachi
Key Responsibilities
Develop, implement, and maintain the Validation Master Plan (VMP).
Lead process validation, cleaning validation, equipment qualification, utility qualification, and computerized system validation activities.
Review and approve IQ, OQ, and PQ protocols and reports.
Coordinate validation activities with Production, Quality Control, Engineering, Supply Chain, and other relevant departments.
Execute process validation studies for solid, liquid, and semi-solid dosage forms.
Monitor Continued Process Verification (CPV) and analyze validation trends.
Ensure analytical method validation and verification are conducted as per applicable ICH guidelines.
Review Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) to ensure process consistency.
Ensure qualification and requalification of manufacturing equipment and utilities in compliance with approved User Requirement Specifications (URS).
Oversee computerized system validation and ensure data integrity compliance.
Review audit trails and electronic records for GMP computerized systems.
Support regulatory inspections, internal audits, and customer audits.
Investigate validation-related deviations and implement CAPAs.
Maintain validation documentation in compliance with GMP requirements.
Qualification & Experience
Pharm-D, M.Pharm, Pharmaceutical Sciences, Chemistry, Engineering, or related discipline.
- 5–8 years of relevant pharmaceutical industry experience, including validation and qualification activities.
