The key responsibilities of this role are mainly:
Complaint management:
- To provide support to the investigation into the complaint carried out by the team in the manufacturing plant, to ensure that the complaint sample is provided to the manufacturing site on time and availability of any other material needed by the CMO for further investigation.
- To provide support related to any additional information needed by the manufacturing site to carry out the investigation.
- To ensure any critical issues get escalated at an appropriate escalation level. To ensure the required investigation is completed and corrective action is implemented on time; track the timely closure of complaints.
- Report Complaint KPIs to ES Quality Council/ Governance Board.
Deviation & CAPA management:
- To track and monitor all the deviations of entire ES functions for timely closure.
- Escalate critical deviations and any overdue situations in deviation closure at Quality Council or ES governance forums.
- Report Deviation KPIs to ES Quality Council/ Governance Board.
- To track the progress of all CAPAs generated at all ES functions for timely closure.
- Escalate any exceptions in CAPA Management in Quality Council or governance forums.
Training management:
- To provide support in management of organizational, personnel and training documentation, including training records, training matrix, training curricula.
- Generation of Job descriptions for every role in the entire ES function for better understanding of roles of every individual in the organization.
- Identification of training needs and development of training plans accordingly.
- Provision of training, including induction, ongoing and refresher and covering hygiene, safety and GxP training.
- Coordinating with Global Learning & Development team for Management of Training activities within ES India Rx
- Tracking and ensuring governance of overall training activities within ES India Rx.
Change Control management
- To assess new change proposals, perform impact assessment, evaluate the justification and identify the actions relevant to the change proposal.
- Drive Change Control AL Panel meetings in line with SOP requirements.
- Evaluate the adequate implementation of the change proposals and provide effective governance on this process.
- To provide updates and escalations related in Quality Council or governance forums.
Periodic Product Review (PPR/APQR) process
- 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.
Documentation & Veeva Quality Documentation
- To track documents due for revision, ensure revisions, retirement/destruction of documents etc.
- To maintain logs of various documents, support for assigning document numbers.
- Support for defining metadata including retention period for SOP, formats and all documents generated in ES India Rx.
- As Veeva Quality Docs Local Admin, resolve the problems arising from the Veeva Quality Docs (Trouble shooting).
- To ensure completion of training required & access management for Veeva Quality Docs.
- To implement global QMS requirements related to data and documentation lifecycle and data integrity management.
- To ensure effective governance on the overall documentation process and escalation to governance forums.
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 to align with global QMS documents or routine revision.
- 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 foreseen relevant to the assigned profile and mitigate it.
- To act as a backup for performing the activities under other profiles, as needed.
- Any additional activities assigned by the Line Manager as and when required.
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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