Operational Quality Section Head At GSK Egypt
Job Description:
- Are you an Operational Quality Section Head who is energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If so, this role is the one for you to explore.
As an Operational Quality Section Head, you will be responsible for following up application of OQ measures in production areas during routine activities and validation practices, handling investigations related to different quality incidents and reporting quality performance and product reviews periodically. You will be monitoring all work activities in the sterile area assuring compliance with GSK standards and GMP regulations and fulfilling Sterile area Manufacturing & filling plans.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
1- GMP
- Revise and update quality related documents, in compliance with Corporate Standards, such as GQP’s, GQG’s, GQMP’s & FPG’s. This includes batch manufacturing and packaging documents, specifications, SOPs.
- Escalate and communicate critical quality issues to local management, where necessary and ensures that actions needed have the appropriate priority
- Ensure application of GMP measures relevant to validation qualifications, change. controls and exceptions handling
- Support Value stream from Quality prospective in achieving the supply goals.
2- Sterile Oversight / Third Party / CMO / Central Team Mngt- Ensure Deployment of GSK Guidelines / Annex Within Sterile Area
- Manage Improvement Plans and Communications with Third Party
- Oversight CMO, Deviations, Complaints, compliance to GSK requirements
- Coordinate Quality operations and compliance with Third Party and central Team
3-Deviations- Ensure proper initial response for handling investigations of deviations, complaints and OOS results, in coordination with production supervisors and ensures implementation of appropriate interim, remedial, mitigation actions.
- Ensure proper handling of deviations, complaints and OOS by OQ team
- Ensure that EHS policies and procedures are implemented during work.
4-Release
- Delegate of Head of Quality in regard to product review – approval for release.
- Management of quality director release handling measurement.
5-Management
- Supervise OQ Inspectors for application of OQ measures in production areas during routine activities and validation practices.
- Increase awareness of subordinates and make the most of using relevant tools for effective Information search and on-going improvement in ways of working.
6-Other functions:
- Conduct self-inspection programs, follows up implementation of required actions and follows up implementation of actions required by other audit levels.
- Report quality performance either monthly or periodically, e.g. Quality Index, OQ Trends (complaints, deviations, NRFT… etc) and Periodic Product Reviews.
- Maintain supply adherence through day to day follow up of product release and
- Ensure the appropriate measures are in place.
- Prepare/conduct the quality council meeting on behalf of head of the quality.
- Management of LIC on behalf of head of quality to co-ordinate initiation, discussions, assessment and final disposition with closure according to GQMP requirements.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s Degree in in pharmaceutical sciences
- Minimum 4 -5 years of experiences in similar role.
- High Experience in Sterile area
- Supervisory, problem solving and report writing skills
- Communication skills and team working spirit
- Good knowledge of ISO, GLP and GMP regulations
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