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Job Description
- IPC testing during all steps of product manufacturing in accordance with governance SOPs
- Ensure proper sampling of intermediate, bulk and finished product batches for routine testing, validation practices and cleaning samples.
- Follow up application of quality assurance measures in production areas and check compliance of IPC testing.
- Ensure implementation of procedures of batch manufacturing and packaging documents, specifications & SOPs.
- Ensure application of quality assurance 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.
- Participate deviations, complaints, OOSs & OOTs in coordination with area owners and ensure implementation of CAPA and closure within required timeline.
- Ensure identification and rejection of non-conforming materials/products according to GMP standards.
- Coaching operators to ensure that quality mindset is embedded in their day to day activities.
Job Requirements
- University graduate, pharmacy or science, with a minimum of 1- 3 years’ experience in a similar field especially in the manufacturing of creams & ointments
- Up to date knowledge of current GMP, EDA Regulatory requirements, WHO & ICH guidelines.
- Preferable knowledge with SAP system
- Familiar with IQ, OQ, PQ, facility, utilities, Equipment, and Strong experiences in cGMP/GLP compliance activities.
- Excellent documentation and report writing skills.
- Excellent verbal and written communication skills.
- Good command of English (spoken and written)
- Good Computer and communication skills (Word and Excel)
- Self-motivation, empowerment, and adaptation to business changes