Operational QA Inspector - Sterile At GSK Egypt
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Operational Quality Assurance Inspector
Job description
Site Name: Egypt - Giza
Are you an Operational Quality Assurance Inspector who is energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If so, this role is the one for you to explore.
As an Operational Quality Assurance Inspector, you will be responsible for following up adherence to OQ system & GMP in production areas, Check batch–related documentation, and provide reports about quality performance against approved standards
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
A. GMP
Follow up application of GMP measures & std procedures in production areas and check compliance of in-process testing.
Ensure application of GMP 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.
Ensure that GMP Standards are followed properly in the manufacturing areas and during the manufacturing processes.
Ensure that GMP standards are followed up in the facility / WH / Utility to serve manufacturing process.
Update Quality related documents to be in compliance with corporate standards.
Handling and management of batch records & OQ quality files in documentation room as per GMP requirements.
Handling and managing retained samples store as per GSP standards.
Revise Quality technical documents according to Corporate Standards, such as GQP’s, and , GQMP’s, This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials.
Handle the performance review of Quality Systems within value stream.
Conduct IPC along with manufacturing, packaging process to ensure quality level maintained.
Provide Quality oversight to the three shifts of production (when required).
Ensure that GMP Standards are followed properly in the Warehouse, Dispensing and manufacturing areas and during the manufacturing processes.
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.
B. Deviations
Report any observed incidents during routine production, conduct required Investigation and follow up its correction and preventive action.
Conduct corrective and preventive action effectiveness check to ensure Quality requirement are met.
Conduct the RCA with the required time frame as per QMS with the responsible area owner and agree on the appropriate CAPA.
Conduct the required investigation for quality complaints and agree on the appropriate CAPA.
Complaint management, conduct RCA with responsible area owner and agree appropriate CAPA.
Handle deviation, complaints and OOS in coordination with area owners and ensure implementation of CAPA and closure within required timeline.
Determine extent/impact/interim actions for deviations, complaints & incidents.
C. Other functions:
Conduct the OQ self-inspection to evaluate the department activities and agree on the action plans.
Attendance of change control process evaluates and approves changes, follow up and track required actions until the CCR implementation.
Support site achieving core & non GMP KPIs within strategy.
Update department SOP in accordance to Quality compliance requirements.
Team member in L1 and provide Quality inputs in CCRs.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree of Pharmacy, Science, Chemistry or equivalent.
1 -2 Years of experience in similar role.
Good written and verbal communication skills
Excellent problem-solving and analytical skills
Keen attention to detail
Basic computer and math skills to calibrate and measure specifications
Excellent Knowledge in Excel & word
Up-to-date knowledge of EDA standards and GMP practices
Documentation and reporting skills
Teamwork and collaboration skills.
Flexibility for Working in night shifts, weekends & vacations as per business' need.
Posting end date: 22 -June – 2023