Operational Quality Officer at GSK
Site Name: Egypt – Cairo
Are you a pharmacy or science graduate who is energized by the opportunity to kickstart and progress their career within the Operational Quality team of one of the leading pharmaceutical companies worldwide? If so, then this opportunity may be the one for you to consider.
As an Operational Quality Officer, you will be responsible to follow up adherence to OQ system and 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 program within OQ department to confirm department adherence to LSOPs and policies.
Simplify 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 proper implementation of ALCOA+ principles Ensure proper handling eject and reject Activities in VS areas
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree in Pharmaceutical Sciences or Science.
2 years of experience, working in a similar role within the same 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.
Good command of English language (spoken and written)
Good Computer (Word and Excel) and communication skills
Knowledge of EHS and GMP requirements