Operational Quality Officer

ob Purpose

Follow up adherence to OQ system and GMP in production areas, check batch-related documentation, and provide reports about quality performance against approved standards

Key Responsibilities:

• Revise Quality technical documents according to Corporate Standards, such as GQP’s, GQG’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.
• 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 processes.
• Handle deviation, complaints and OOS 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.