Assistant Manager QA Inspection

Position: Assistant Manager QA Inspection

Reporting to: Head of Quality Assurance

Division: Established Pharmaceutical Division - Operation

Location: Karachi -Pakistan

Job Summary

Assist Head of QA in all in process and inspection checks of production operations and facilities (e.g., required building / Environmental / equipment etc.) Per Abbott Policies, AQ, EQDs, SOPs, GMP and Drug Act. Area GEMBA’s for inspection readiness, check logbooks and other documents with reference to Data integrity, sampling of bulk, intermediate and finished products.

Major Responsibilities

• Assistant Manager must ensure to Manage that the activities in his Section of responsibilities do not result Delay or non-availability of products
• Line clearance and in process checks of manufacturing and finishing operations, GEMBA Inspection of Warehouse, Utilities, and facilities as per Abbott Policies / Procedures, GMP and Guidelines
• Sampling of intermediate, bulk, finished and stability products
• Maintain and improve of existing quality processes to ensure continuously appropriate/compliant operations in production and storage areas
• Responsible for SOP write up / Revision / Implementation as per AQ, EQDs, SOPs, Drug Act, cGMP etc
• Daily Planning, Training and Management of QA Inspectors
• Ensure that all necessary documentation is completed accurately, in a timely manner, and in compliance with data integrity and regulatory requirements
• Ensure calibration / verification of In-process related equipment’s / instruments
• Participate in Validation and Qualification activities related to Process, Equipment and Facilities, whenever required
• 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 and Audit follow-up for corrective action implementation in his area of activity
• 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
• Train newly inducted QAIs in production areas on QA related processes / procedures
• Ensure that workplace is compliant with all applicable health and safety regulations and report any workplace safety / near miss incidents and follow-up till closure
• Handling of Drug inspector’s samples and Work as Training coordinator of QA Inspection
  
  

Education/Knowledge & Experience

• Science Graduate/Master; preferably Chemist/Pharm D
• 3-4 years’ experience in the same capacity
• Knowledge of QA documentation, technical problem resolution, and other all activities taking place in QA
• Proficient in MS Office
• Analytical Skills