Job Purpose
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
- Must have an experience of at least 2-3 years of experience with overall knowledge of Site Operations. Knowledge of Site Manufacturing, Warehouse, Engineering and Utility Operations and their Contribution in Site Role.
- Excellent communication and inter personal skills.
Key Responsibilities
- To ensure all facilities equipment and operations at site are validated (DQ, IQ, OQ, PQ) in line with regulatory and corporate requirements.
- To provide validation support to the continuous improvement automation of corporate projects in an environment of rapid change
- 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.
- To prepare data for update of validation activities for site Quality Council Meeting
Site Validation Master Plan
- Creating and maintaining Site Validation Master Plan (SVMP) in compliance with the group quality policies and regulatory requirements.
- Creating and maintaining VMPs as appropriate for new projects such as upgrades to facilities, new product induction
- Coordinate with engineering department in order to ensure availability of DQ, IQ, and OQ.
Performance Qualification Protocols
- Creating / facilitating validation protocols which fulfill current compliance requirements
- Consulting with production, quality function, stores and engineering
- Managing changes to validation protocols
- Continuous improvement, periodic review and collaborating with user departments and support groups
- Preparation of Validation summary reports to meet customers and release deadlines.
Cleaning Validation and Verification
- Validation of cleaning procedures of production related equipment
- Preparation of cleaning validation protocols for new manufacturing and filling equipment and or to incorporate changes or products.
- Preparation of cleaning verification protocol for non-routine production activities.
- Coordinate to carry out cleaning validation exercise with Planning, Production and Lab Operations.
Periodic Reviews
- Periodically reviewing validated manufacturing and filling process, equipment, utilities, facilities, cleaning processes in order to ensure that they remain in validated status.
Audit Readiness
- Being ready for audit all the time.
- Ensuring that all the validation documentation is complete, accurate and accessible.
- Participating in audit preparation and related training
Manufacturing of trial/experimental batches
- Time to time monitoring of trial/experimental batches being manufactured at site and ensure compliance.
Training
- Ensure that the trainings on validation related SOPs have been delivered in time to all the stakes holders.
- To ensure that all the SOPs related to Validation department are in place and in use.
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
- To follow up validation status of DQ/IQ/OQ/PQ status
- To participate in PQ of sterile area equipment
- To prepare volition protocol/reports of product validation and cleaning validation of equipment.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Contact information:
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