وظائف شركة جلاكسو سميثكلاين العالمية للادوية GlaxoSmithKline
Operational Quality Officer
Key Responsibilities:
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 L1 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.
Basic Qualifications:
University
graduate at the Faculty of pharmacy
A minimum of one-year 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.
Good command of English (spoken and written)
Good Computer and communication skills (Word and Excel)
Knowledge of EHS and GMP requirements
Preferred Qualifications:
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
