OQ Sterile Inspector At GSK
Site Name: Egypt - Giza
Job Purpose
Maintain Aseptic compliance of sterile area, by operating with the standards (GMP, GSK guidelines, WHO & MOH) requirements for aseptic Manufacture.
Ensure that there is a sustainable delivery for sterile products with quality desired.
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:
1. Conduct pre-operational inspection regarding Env. Conditions, LAf performance, machine performance, qualification, calibration and maintenance status of the machines.
2. Conduct appropriate in process controls for every area according to its requirements.
3. Conduct online IPC testing (weight check, C02, leakage, torque if any).
4. Ensure that online testing and challenges are being conducted and ensure their results are satisfactory.
5. Observe media fills regarding every area, ensure that operation process was completely simulated, and identify gaps if any regarding behaviours and operational steps conducted.
6. Revise Quality technical documents according to Corporate Standards, such as GQP’s, GQG’s, GQMP’s and. This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials.
7. Review batch records, log books, charts & printouts prior to batch release.
8. Be part of the decision taking in regards of any findings and gaps regarding sterile operation. Follow up the closure of agreed CAPAs.
9. Constant communication with sterile area personnel about aseptic behaviour expectation to raise their compliance and enhancing their contribution for better performance.
10.Support in compliance gap analysis standard operating procedure governing both sterile areas versus Aseptic guidelines and requirements, in order to unify the major operational procedures in relevance to requirements and regulations.
11.Qualified for sterile area with all it’s aseptic behaviours.
12.Review & ensure main systems for sterile area governance (Air system, Environment conditions sterile behaviours, gowning procedure, M/C requirements and utilization within sterile area) are in compliance with GQPs &GQMPs designated for aseptic management.
13.Ensure proper sampling of intermediate, bulk and finished product batches for routine testing, validation practices and cleaning samples.
14.Monitor calibration of production equipment and IPC testing instruments.
15.Review batch related documentation for completeness, correctness and compliance to approved standards.
16.Report any observed incidents during routine production and follow up its correction and corrective action.
17.Ensure identification and rejection of non-conforming materials/products according to GMP standards.
18.Coaching operators to ensure that quality mindset is embedded in their day to day activities.
B.Deviations
1. Conduct through comprehensive investigations for deviations and OOS and apply RCA methodology to identify Root cause and the most appropriate CAPAs addressing it.
2. Review sterile area contribution to site KPIs, identify the issues and develop CAPAs and opportunities to depreciate the % contribution of deviation, documentation, batch rejection hitting site.
C.Other functions:
1. To be in charge of handling changes executed in both areas through CCR system and ensure that change is fully maintained and conducted to raise bar of aseptic compliance.
2. Involve in LI regarding both sterile area to identify any issues in advance, ensure that an appropriate CAPA is being executed.
3. Team member in L1 and provide Quality inputs in CCRs.
4. Support GPS implementation in managing different activities.
Knowledge/ Education / Previous Experience Required:
Bachelor’s degree of pharmacy
Minimum 3 to 4 Years of experience, in Sterile Production, Quality Assurance
Essential Skills and Abilities:
1. Good command of English (spoken and written).
2. Good Computer skills (Word and Excel).
3. Very good communication skills.
4. Knowledge of GLP &GMP requirements.