Primary responsibilities for this role are as follows:
To drive Specifications Management process for ES India Rx.
To drive Pharmacopeial Compliance of ES India Rx products
To drive PTL oversight process for GSK approved PTLs for ES India Rx
To drive Stability process within ES India Rx.
To drive Periodic Product Review Process within ES India Rx.
To coordinate for Quality & Regulatory Intelligence (QRI) activities related to ES India Rx.
To drive the process of Quality Agreement with External Suppliers of ES India Rx.
The key responsibilities of this role are mainly:
Specification Management
Review, Revision, and Issuance of FPS / RMS / IMS / PMS related to LL products.
Ensure Specifications are aligned to Pharmacopoeia requirements all the time.
Ensure Regulatory specifications are updated & provide timely support for regulatory requests.
Maintain Specifications throughout their life cycle.
Pharmacopoeia Compliance
Track and implement pharmacopoeia changes on routine basis and as & when changes are notified by relevant pharmacopoeia, to ensure 100% adherence to pharmacopoeia requirements before the effective date.
Track and evaluate the draft proposals for comments in applicable pharmacopoeia for relevant changes & coordinate with Regulatory/PIAG team on these aspects.
Oversight for GSK approved Public Testing laboratories of ES India Rx
To track auditing of the PTLs approved by GSK and maintain the list of approved GSK approved PTLs.
Stability Studies
Tracking of stability study testing of ES products on monthly basis.
Review of stability report for any significant change for ES products.
Escalation of significant change to relevant Governance forums.
Stability data evaluation to support extension / restoration of shelf-life for ES products.
Periodic Product Review
Tracking of CMOs PPR & identified review actions for completion.
Review of PPR and executive summary report.
Updates and Escalations related to PPR process in relevant Governance forums.
QRI coordinator
To ensure, all the relevant QRI communications are evaluated in coordination with sites for applicability & perform business impact assessment, if applicable.
Coordinate with respect stakeholder for ensuring implementation of the QRI requirements.
Quality Agreement Coordinator
Prepare / Revise Quality Agreements with CMOs.
Prepare Amendments to the Quality Agreement for change in the responsibility or other details.
Other responsibilities
To ensure all the KPI targets for relevant profiles are achieved and provide the relevant data/updates in this regard to ES Quality council and other forums.
To ensure the SOPs of relevant profiles are revised as per need or routine revision.
To ensure the responsibilities and tasks mentioned in the IPTc are completed.
To conduct MM/IBM audits within External Supply India Rx.
To ensure QMS actions related to profile are raised and completed on time.
To ensure all time inspection readiness for above mentioned profiles.
To carry out annual reviews of the processes to identify improvement opportunities.
To identify and log the risks in RMS for risks foreseen relevant to the assigned profile.
To act as backup for performing the activities under other profiles, as needed.
Any additional activities assigned by the Line manager as and when required.
Basic Requirements:
Education: Post-Graduate in Science / Pharmacy discipline.
Experience: Preferably 10 plus years’ experience in Quality Control activities and Quality Assurance in Quality Management Systems.
Special Knowledge: Good Knowledge of Analytical, Documentation / Regulatory requirements & Quality Management Systems.
Effective verbal and communication skills, collaborative team member & team leader.
Capable to work independently & efficiently.
Business understanding: Understanding the pharmaceutical industry.
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.
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