GlaxoSmithKline Pharmaceuticals Limited Nayan Mandir Trust
GlaxoSmithKline Pharmaceuticals Ltd. (GSK Pharmaceuticals India) is one of the oldest pharmaceuticals company. Established in the year 1924 in India, with a mission to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to provide effective healthcare solutions in both acute and chronic diseases.
Job Title: External Supply Quality Assistant Manager
Job Description:
- To ensure Implementation of QMS requirements at contract sites and to ensure that product is getting manufactured at the site as per cGMP requirements.
- To provide support in the area of regulatory compliance at contract sites and to ensure no disruption of supply & no regulatory punitive action, Review and issue revised PPI, SPS and Artworks to contract manufacturing site and ensure that only current versions are in use at site.
- To Support ESA audits .Follow up with sites for compliance of audit and visit observations. Ensure CAPAs are adequate and are tracked to completion ensuring zero CAPA extensions.
- Perform QMS gap analysis and follow-up for effective QMS implementation.
- Monitoring and review PPR for all products manufactured at ES sites. Implement corrective actions arising out of PPR involving Central Quality Cell.
- To support timely release and delivery of finish products by timely resolution of quality related issues.
- To provide support to contract sites to continuously improve contribution to business performance management. To support the quality control department by providing timely reference standards of APIs as well as related impurity standards.
- Ensure that there is well define stability program in place and is maintained by site for all products. Ensure stability study is conducted for all products at all sites as per schedule. Review of stability data on regular basis to identify any significant changes / stability failures and to ensure relevant actions.
- To handle quality issues related to raw and packing materials, review and approve destruction or return of defective raw and packing materials to vendor and to coordinate and ensure CAPA implementation at vendor site.
- To assist in smooth Product Transfers and meeting on time market requirements.
- To work as a product owner for PLM activity on responsible site.
Qualifications:
Education:
- UG -B.Sc – Any Specialization, B.Tech/B.E. – Any Specialization, B.Pharma – Pharmacy
- Doctorate – Ph.D – Bio-Chemistry/Bio-Technology, Chemical, Chemistry, Medicine, Pharmacy
