Position: Senior QA Inspector

Reporting to: Manager QA Inspection

Division: Established Pharmaceutical Division - Operation

Location: Karachi -Pakistan

Job Summary:

Assist QA Inspection Manager 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:

• To make sure that activity does not result in,
• Delay or non-availability of product.
• Delay in introduction of new products.
• Any non-compliance of cGMP (current Good Manufacturing Practices), GSP (Good Storage Practices) and EHS (Environment, Health & Safety) requirement.
• To assist Manager QA Inspection in ER and CAPA management.
• To assist Manager QA Inspection in quality complaints management.
• To assist Manager QA Inspection in Departmental, Internal, Divisional and Corporate Audits.
• To assist Manager QA Inspection for Quality Metrics Report.
• To assist Manager QA Inspection to collect data and performing Quarterly Trend report.
• To Assist Manager QA Inspection in Audit follow-up for corrective action implementation in his/her area of activity.
• 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.
• Work closely with other departments to facilitate in maintaining compliance of the applicable systems for change controls, CAPA, ERs, complaints, internal GxP audit observation follow ups and CAPA effectiveness.
• Responsible for SOP write up / Revision / Implementation as per AQ, EQDs, SOPs, Drug Act, cGMP etc.
• Maintain and improve existing quality processes to assure continuously appropriate and compliant operations in production and storage areas.
• To ensure that workplace is compliant with all applicable health and safety regulations. Report any workplace safety / near miss incidents and follow-up till closure.
• Line clearance and In process checks of production manufacturing and finishing operations, GEMBA Inspection of Warehouses, Utilities and facilities (e.g., building / environmental / equipment / utilities / systems etc.) per Abbott Policies / Procedures, and cGMP Guidelines.
• To assure verification of all necessary checks and requirements for the dispensing activities before granting line clearances as per respective procedures.
• Raw Materials issue verifications as per approved Manufacturing Shop Order.
• Packaging Commodities Issue verifications as per approved Finishing Shop Order.
• Perform sampling activities as and when required per the applicable procedures.
• To ensure that all necessary documentation is completed accurately in respective areas, in a timely manner, and in compliance with data integrity and regulatory requirements.
• To ensure calibration / verification of equipment / instruments used for In-process checks.
• To participate in Validation and Qualification activities related to Process, Equipment and Facilities, whenever required.
• Handling of Regulatory samples for submitting to respective Drug Inspectors.
• Any special project assigned by Manager QA Inspection.
• Proceed for Rejected material incineration activity when assigned.

Education/Knowledge & Experience:

• Science Graduate/Master; preferably Chemist/Pharm D
• 2-3 years’ experience in the same capacity
• Knowledge of QA documentation, Deviation, CAPA and Customer Complaint management, Line Clearance, Validation, Stability, technical problem resolution, and other all activities taking place in QA
• Proficient in MS Office
• Analytical Skills