Assistant Manager Quality Assurance

Position: Assistant Manager Quality Assurance

Reporting to: Head of Quality Assurance

Division: Established Pharmaceutical Division - Operation

Location: Karachi -Pakistan

Job Summary

Support the Head of QA in conducting in-process and inspection checks for production operations and facilities (e.g., buildings, environmental conditions, equipment) in accordance with Abbott Policies, AQ, EQDs, SOPs, GMP, and the Drug Act. Perform Area GEMBA walks to ensure inspection readiness, compliance checks, and review logbooks and other documents for data integrity. Additionally, sample bulk, intermediate, and finished products.

Major Responsibilities

• Line clearance and in process checks of manufacturing and finishing operations, GEMBA Inspection of Warehouse, Utilities
• Maintain and improve of existing quality processes to ensure continuously appropriate/compliant operations in production and storage areas
• Daily Planning, Training and Management of QA Inspectors
• To ensure calibration / verification of In-process related equipment’s / instruments
• To participate in Validation and Qualification activities related to Process, Equipment and Facilities, whenever required
• To assist Head of QA in data collection and preparation of Quality metrics and Quarterly trend reports
• Audit of batch documents and disposition of finished products
• To actively participate in handling of exception reports, internal quality investigations and customer complaints related to his / her area for root cause identification and CAPA implementation
• Handling of Drug inspector’s samples
• Work as Training coordinator of QA Inspection
• Work closely with other departments to facilitate actions and maintain compliance to the current systems for change controls, CAPA, ERs, complaints, internal GxP audit observation follow ups / CAPA effectiveness
  
  

Education/Knowledge & Experience

• Science Graduate/Master; preferably Pharm D
• 4-5 years’ experience in the same capacity
• Knowledge of QA documentation, Validation, Stability, technical problem resolution
• Proficient in MS Office
• Analytical Skills