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, Operational Quality Section Head role is the one for you to explore.
As an Operational Quality Section Head, you will follow 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 .
This role will ensure that the mandated Quality Management Systems and local Regulatory requirements for LOC are met.
Key Responsibilities:
Supervise and approve the release of manufactured batches to both local and export markets after review of all required documentation, ensuring that batches are released after fulfilling all GMP requirements.
Supervise OQ officers for application of OQ measures in production areas during routine activities and validation practices.
Revise and update quality related documents, in compliance with Corporate Standards, such as GQPs, GQGs, and GQMPs. This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials.
Handle investigations of deviations, complaints and OOS , OOT results, in coordination with production supervisors, Labs, Warehouse and ensures implementation of appropriate corrective and preventive actions and ensure investigation closure within specified time with intended Quality requirements.
Conduct self-inspection programs, follows up implementation of required actions, and follows up implementation of actions required by other audit levels and responds to L2, L3 and L4 audits in OQ department.
Report quality performance either monthly or periodically, e.g. Site KPI’s, OQ Trends (complaints, deviations … etc).
Escalate and communicate critical quality issues to local management, where necessary, and ensures that actions needed have the appropriate priority.
Ensure application of OQ measures relevant to validation qualifications, change controls and exceptions handling.
Accountable for training of Officers and the technical / personal development of his/her direct reports.
Support GPS foundations implementation (TIPS and TAPS) and increase awareness of subordinates and make the most of using GPS tools for effective performance and on-going improvement in ways of working.
Ensure that EHS policies and procedures are implemented during work and that all manufacturing and packaging processes are done according to GMS requirements.
Responsible to participate in Self Inspection programme within OQ department to confirm department adherence to LSOPs and policies.
Batch record review prior to batch release to market.
Knowledge about SAP and QWF.
Review & document PCCE risk assessment related to each area in the VS with appropriate controls to minimize any potential process risks.
Handling of PCCE incidents in the VS areas.
Responsible for and Ensure proper implementation of ALCOA+ Principles.
Ensure proper handling of Ejects and Rejects activities in all VS areas.
Conduct relevant microbiological risk assessments and develop effective risk mitigation plans with coordination of different stakeholders
Job Qualifications:
We are looking for professionals with these required skills to achieve our goals:
University graduate, pharmacy or science, with a minimum five year’s experience in similar field
Up to date knowledge of current GMP, EDA Regulatory requirements, GSK QMS System.
Excellent documentation and report writing skills.
Excellent verbal and written communication skills.
Familiar with IQ, OQ, PQ, facility, utilities, Equipment and Strong experiences in cGMP/GLP compliance activities.
Preferred Qualification:
Good command of English and computer skills.
Self-motivation, empowerment and adaptation to business changes.
Strong prioritization and organization skills.
Able to demonstrate experience of managing diverse teams of professional staff and effective budgetary control against agreed targets.
Closing Date:
24/03/2024
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