Quality Excecutive

Basic Qualifications

Bachelor Degree inPharmaceutical Sciences or equivalent.Minimum 4 years experience within multinational pharmaceutical organizations.Relevant qualifications and / or experience is essential.Excellent knowledge in the areas of Quality Management Systems, Regulatory and legal requirements governing the manufacturing and supply of products.Auditing skills, good knowledge about GSK audit process and third party audits is a plus.Experience working in GMP/GDP environment.Strong technical writing ability.Strong attention to detail.Have excellent command of the English language

Details

Preferred qualifications:

Job Details

The Quality Executive will be reporting to Cluster Quality Manager on job grade 8 and based in the Boomerang Head Office.

Job Purpose

To manage quality related operations within Egypt - Near East cluster, support business activities to ensure compliance to QMS policies/ processes and applicable local regulations.

Major Responsibilities Include

QMS Implementation within LOC cluster, responsible for:

Conducting GAP Analysis for newly issued or updated QMS policies and processes with different LOC functions.

Ensure the risk areas in relation to QMS activities within the LOC are identified and the risks are appropriately assessed and escalated to local/regional Quality Council meetings and RMCB as required; as well as proper development and follow-up of mitigation plan(s).

Conducting QMS training for LOC staff as required.

Ensure implementation and maintenance of effective quality assurance systems within LOC cluster and ensure that quality related operations are in full compliance with GSK standards and policies, regulatory requirement, good storage and distribution practices.Support in the creation and implementation of the Quality plan aligned with regional objectives for LOC cluster in liaison with cluster quality manager.Following up on Quality KPIs for LOC cluster, ensure that Quality targets are met & any improvement plans are developed.Audit Readiness; ensure that LOC organization or contracted third parties are continuously ready for any internal or external inspection.Contribute in the preparation of the quality councils for LOC cluster.Management of technical terms of supply, responsible for setting and updating TTS between GSK supplying sites and LOCs to ensure the compliance of the distribution process with all regulatory requirements.Quality Alerts Management within LOC cluster, responsible for accepting or rejecting all GSK quality alerts, conducting assessment, and developing CAPAs for any identified gaps.Management of product quality complaints, responsible for communicating with complainants to ensure data and sample gathering, liaising with manufacturing sites to conduct investigations and provide the appropriate feedback to the complainant.Support internal audit program for LOC cluster, defining internal audit universe, maintaining schedule, conducting audit runs and writing audit reports for all functions within LOC affecting product quality in liaison with cluster quality manager.Setting Quality Agreements between commercial organization and third party manufacturing sites, service providers and distributors.

Contact Information

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

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