Position:              Senior QA Inspector

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:

Sr QA Inspector 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 GuidelinesSampling of intermediate, bulk, finished and stability productsMaintain and improve of existing quality processes to ensure continuously appropriate/compliant operations in production and storage areasResponsible for SOP write up / Revision / Implementation as per AQ, EQDs, SOPs, Drug Act, cGMP etcDaily Planning, Training and Management of QA InspectorsEnsure that all necessary documentation is completed accurately, in a timely manner, and in compliance with data integrity and regulatory requirementsEnsure calibration / verification of In-process related equipment’s / instrumentsParticipate in Validation and Qualification activities related to Process, Equipment and Facilities, whenever requiredAssist Head of QA in data collection and preparation of Quality metrics and Quarterly trend reportsAudit of batch documents and disposition of finished products and Audit follow-up for corrective action implementation in his area of activityActively participate in handling of exception reports, internal quality investigations and customer complaints related to his / her area for root cause identification and CAPA implementationTrain newly inducted QAIs in production areas on QA related processes / proceduresEnsure that workplace is compliant with all applicable health and safety regulations and report any workplace safety / near miss incidents and follow-up till closureHandling of Drug inspector’s samples and Work as Training coordinator of QA Inspection

Education/Knowledge & Experience:

Science Graduate/Master; preferably Chemist/Pharm D2-3 years’ experience in the same capacity Knowledge of QA documentation, technical problem resolution, and other all activities taking place in QAProficient in MS OfficeAnalytical Skills