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Site Name: Pakistan - Sindh - Jamshoro
Posted Date: Apr 22 2020

This Role will be based in Jamshoro

Job Purpose

Manage all quality aspects of deviation/complaint handling/ Internal Audit process for all products according to deviation/complaint handling / Internal Audit SOP, self-inspection, CAPA management, LIC, QCM related GQP, GQG and GQMP also ensure the completion of CAPA's on time.

Ensure that training of deviation handling procedure as well as the deviation handling system undertaken by all stakeholders.

Ensure that training of complaint handling procedure as well as the complaint handling system undertaken by all stakeholders

Experience & Education Required

Bachelors in Science

Minimum 5 years with Investigation of deviations/complaint, process knowledge, investigation tools understanding, Internal audits

Specialization in QA, Regulatory, QC, Q. Compliance

Key Responsibilities

· Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.

· Comply and ensure compliance to Environment, Health and Safety policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.

· Lead and manage the site internal audit program. Ensure that GMP audits are performed as per annual audit schedule and conduct due diligence audits if required.

· Manage the site Complaints Handling processes and ensure that all product quality complaints are adequately investigated, reported and any follow-up activities initiated in compliance with the GSK Quality Standard and regulatory and legislative requirements

· Ensure timely and complete product quality investigations related to Product Recall, Counterfeit and/or Withdrawals in close interaction with QA functions. Making sure that manufacturing or production processes meet international and national standards. Defining quality procedures in conjunction with operating staff. Making suggestions for changes and improvements and how to implement them Using relevant quality tools and making sure associates and other staff understand how to improve the business.

· Ensure that deviations are logged in QWF (Carisma3) & investigated on time.

· Ensure that complaints are logged in CRS & investigated on time.

· Ensure that deviations/complaints and all respective documents/samples are archived according to GSK guidelines. Identify the CAPA (preventing & corrective actions) to eliminate "clusters" and recurrence. Ensure the CAPA management system and timely closure of CAPA's, Check all feedback for plausibility and completeness and CAPAS,

· Provide support during inspections and questions regarding deviations/complaints.

· Perform gap assessment of all applicable QMS documents in the compliance department and assure adherence to QMS documents and regulatory requirements.

· Perform the internal audits as per GSK guidelines

· Provide support to team in the self-inspection.

· Provide support in the quality council.

· Review the KPIS for deviations/complaints monthly as well as quarterly reports and annual reports (deviations) as defined ((root cause, criticality, CAPA effectiveness, etc.).

· Aligned with the Compliance Head all critical deviations/complaints are escalated to management on time.

· Comply and ensure compliance to Environment, Health and Safety policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.

· Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.

· Any other responsibility assigned from time to time as per business requirements.

Contact information:
You may apply for this position online by selecting the Apply now button.

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