Sr. QA Executive (IPC)

Responsicities
•    Ensure proper sampling of intermediate, bulk, and finished product batches for routine testing, validation practices, and cleaning samples.

•    Follow up on the application of quality assurance measures in production areas and check compliance with 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 with approved standards.

•    Report any observed incidents during routine production and follow up on their 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 in deviations, complaints, OOSs & OOTs in coordination with area owners and ensure implementation of CAPA and closure within the required timeline.

•    Ensure identification and rejection of non-conforming materials/products according to GMP standards.

•    Coaching operators to ensure that a quality mindset is embedded in their day-to-day activities.

•    Performing an internal audit on each department, to ensure the implementation of the procedure in the plant through reviewing the training system in each department. 

•    Performing APR activities

•    Notify the IPC /compliance section head of any problem encountered.

•    Ensure that the requirements for data integrity at the site are in place by conducting spot audits

•    Follow AQL procedure during sampling, inspection and investigation of the defective bulk, intermediate or packaged product and reporting results to Deviation management process owner.

•    Creation of MPN in the system after ensuring that the subject

•    Conduct a walkthrough tour in technical areas and immediately report the observations \findings to the QA manager/delegate.

•    Follow up on waste management.

• Inspection, verification of defect and defective quantity for in-process batches, analysis of the impact of the defect, and follow-up for the required online action.

Qualifications:-

•  5-7 years’ experience in the pharmaceutical industry field, especially in sterile manufacturing.

•  A suitable university degree is preferred to be as a B.Sc. in Pharmacy or Science.

•  Up-to-date knowledge of Good Manufacturing Practices and related local regulations.

•  Familiar with IQ, OQ, PQ, facility, utilities, Equipment, and Strong experience in cGMP/GLP compliance activities.

•  Excellent documentation and report writing skills.

•  Ability to work night shifts is a must.

•  Up-to-date knowledge of current GMP, EDA Regulatory requirements, WHO & ICH guidelines.

•  Preferred knowledge of the SAP system.

•  Good command of English (spoken and written).