QA Inspection Manager

JOB DESCRIPTION:

Job Summary:

Assist the Head of Quality Assurance in Compliance self-inspection, 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, Drug Act. Also assist Director Quality Assurance in Quality Metrics
report, Quarterly Management Review, Abbott Monthly Review Meetings (Site AMR), Quarterly Trend report, KPIs calculations, Area GEMBA’s for inspection readiness, check logbooks and other documents with reference to Data integrity.

Principal Duties:

• To make sure that activity does not result in,
• Delay or non-availability of product.
• Delay in introduction of new products.
• Delay in implementation of CIP.
• Failure of the team.
• Compromise on quality GMP and GLP.

• In process checks of manufacturing and finishing operations, GEMBA inspection of Warehouse, Utilities, and facilities (e.g., required building /environmental / equipment etc.) as per Policies / Procedures, GMP and Guidelines.
• Responsible for SOP write up / Revision / Implementation as per AQ, EQDs, SOPs, Drug Act, cGMP, and ISO requirements as agreement of Director QA.
• To assist Director Quality Assurance to collect data and preparing monthly Quality Metrics Report.
• To assist Director Quality Assurance to collect data and performing Quarterly Management Review.
• To assist Director Quality Assurance to collect data and performing Abbott Monthly Review Presentation/Meetings.
• To assist Director Quality Assurance to collect data and performing Quarterly Trend report.
• Audit & release of finished products (Batch document review).
• Involved in Quality Risk Management, Change control assessment, Product / waste incineration process, Line clearance activity in Production areas, OOS / OOT investigation and approvals.
• Audit follow-up for corrective action implementation in the area of activity.
• To perform as an active member of CAPA (Corrective Actions & Preventive Actions) team and complete responsibilities as and when assigned.
• Perform all activities as regional CAPA SME (Subject Matter Expert)
• Assist Director Quality Assurance in completing PEX cycle of QA Inspection.
• To participate as a team member in investigation of Exception reports and Complaints and approval.
• Prepare EPO highlights.
• Handling of samples picked by drug Inspector.
• Calculation of KPI & discuss the trend with Head of Quality Assurance.
• Assist Director Quality Assurance in training & certification program & follow up of QA area.
• Any special project assigned by Director QA.
• Review manufacturing and packaging directions.
• Review of Packaging Approval Note (PAN).

Knowledge & Experience:

• Knowledge of QA documentation, Validation, Stability, technical problem resolution, and other all activities taking place in QA/QC.
• 07-10 years of experience in relevant field.

Competencies required:

• Good computer skills
• Good Communication and interpersonal skills
• Negotiation Skills
• Leadership skills
• High Analytical skills
• Build Organization & inspire People
• Technical and Analytical Skills
• Level III training as per SOP QA-004-01

Minimum Qualifications:

• B Pharm/Pharm D / M.Sc.
• Science Graduate or master's in science, preferably Pharmacy Graduate with 7-10 years’ experience.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:ManufacturingDIVISION:EPD Established PharmaLOCATION:Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, LandhiADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:NoMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)