Operational Quality Officer at GSK

Job description

Are you an Operational Quality Assurance Officer 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 Assurance Officer, you will be responsible for following up adherence to OQ system & GMP in production areas, Check batch–related documentation, and provide reports about quality performance against approved standards

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Revise Quality technical documents according to Corporate Standards, such as GQP’s, GQMP’s and FPG’s. This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials.
Ensure proper sampling of intermediate, bulk and finished product batches for routine testing, validation practices and cleaning samples.
Follow up application of OQ measures in production areas and check compliance of in-process testing.
Ensure application of OQ measures during validation batches and planned changes.
Monitor calibration of production equipment and IPC testing instruments.
Review batch related documentation for completeness, correctness and compliance to approved standards.
Report any observed incidents during routine production and follow up its correction and corrective action.
Ensure that GMP Standards are followed properly in the Warehouse, Dispensing and manufacturing areas and during the manufacturing and packaging processes.
Handle deviations, complaints and OOS & OOT in coordination with area owners and ensure implementation of CAPA and closure within required timeline.
Team member in self inspection and provide Quality inputs in CCRs.
Support EHS & GPS implementation in managing different activities.
Ensure identification and rejection of non-conforming materials/products according to GMP standards.
Responsible to participate in Self Inspection programme within OQ department to confirm department adherence to LSOPs and policies.
Ease the production process with meeting GSK quality standards
Coaching operators to ensure that quality mindset is embedded in their day to day activities.
Handling PCCE incidents in the VS Areas.
Responsible for and ensure propper implementation of ALCOA+ principles
Ensure proper handling eject and reject Activities in VS areas.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

University graduate, pharmacy or science.
1 -3 Years’ experience in similar role.
Knowledge of EHS and GMP requirements 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.
Good command of English (spoken and written)
Good Computer and communication skills (Word and Excel).

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