OQ Section Head

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.

- Key Responsibilities:

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- 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.

3- Release

• Delegate of Head of Quality in regard to product review - approval for release.
• Management of quality director release handling measurement.

4- 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.

5- 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.