Site Name: Pakistan – Sindh – Karachi
Posted Date: Sep 7 2022
To ensure compliance with local regulatory requirements and QMS related to validation by managing & performing validation studies of facility, utilities, equipment, laboratories, computerized systems and processes that have an impact on the quality of GMP regulated products and building quality into all quality critical systems.
Education, Experience & Skills
M.Sc. / B. Pharm. / Pharm D degree from a reputable university.
Minimum 2–3 years’ experience in a pharmaceutical industry in QMS / Validation / Production/ Quality
Overall knowledge of Site Operations. Knowledge of Site Manufacturing, Warehouse, Engineering and Utility Operations and their Contribution in Site Role.
- Describe the key deliverables, specific duties, any specialist duties and the ongoing responsibilities of the role.
- To ensure all facilities equipment and operations at site are validated (DQ, IQ, OQ, PQ) in line with regulatory and corporate requirements.
- To coordinate / complete validation of new non-lactam sterile project within defined timeline.
- To coordinate with multi-functional validation working party (VWP) in achieving validation targets as per defined timelines.
Site Validation Master Plan
- Creating and maintaining Site Validation Master Plan (SVMP) in compliance with the group quality policies and regulatory requirements.
Performance Qualification Protocols
- Creating / facilitating validation protocols which fulfill current compliance requirements
- Consulting with production, quality function, stores and engineering
Cleaning Validation And Verification
- Validation of cleaning procedures of production related equipment
- Coordinate to carry out cleaning validation exercise with Planning, Production and Lab Operations.
- Periodically reviewing validated manufacturing and filling process, equipment, utilities, facilities, cleaning processes in order to ensure that they remain in validated status.
- Ensuring that all the validation documentation is complete, accurate and accessible.
Manufacturing Of Trial/experimental Batches
- Time to time monitoring of trial/experimental batches being manufactured at site and ensure compliance.
- QMS Implementation:
- To keep Validation department in line with the GOPs and GQMPs related to Validation.
- To Participate in GAP analysis session related to Validation
Sterile Non-Lactam Project
- To prepare VMP of Non-Lactam sterile project
- To conduct VWP sterile project meeting in regular basis
You may apply for this position online by selecting the Apply now button.
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