GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders. At GSK, our mission is 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 effective healthcare solutions.
Post: Executive/Asst. manager- Regulatory & Compliance
Job Description
- To ensure compliance to regulatory and GSK Quality Management System requirements.
- Co-ordination with Tender Business Team, local FDA, Regional / Global Quality function, Manufacturing / Packing, Engineering, Warehouse and other support functions.
- Tracking of self inspection and internal audits as per the audit schedule. Review of self inspection audit reports for compliance to SOP requirements. Logging of CAPA actions of the site self inspection audits into central CAPA tracker.
- Perform allotted self inspection & internal audits as per schedule & track the CAPAs for completion.
- Perform annual review of the self inspection & internal audit systems and tracking of the actions for timely completion.
- Tracking of Quality Management System (QMS) implementation activities as per the plan. Review of gap analysis of QMS documents and tracking of actions arising out of the same.
- Ensure gap analysis of new/revised/existing QMS documents & revision of applicable SOPs in timely manner.
- Preparation and timely review of Technical Terms of Supply for export purpose. Co-ordinate with the exporting country contacts for TTS change control, registration related requirements.
- Compilation of data/details required to support the tender business.
- Preparation of Print Pack Instructions & follow up for approval of the same from other functions. Review of the Artwork prior to approval. Maintain record of the above activities.
- Timely Pharmacopoeial review to ensure product & processes are in continuous compliance with the regulatory requirements.
- Regulatory intelligence, timely review / screening of newsletters, monitoring websites, gazettes, notifications.
- Tracking and review of Key Performance Indicators (KPI). Timely support & inputs for achieving Quality KPI targets.
- Extend necessary support for new product export dossier preparation by coordinating with other support functions.
- Risks applicable in areas of responsibility are escalated in risk register in timely manner; actions are tracked for completion as per the agreed mitigation plan.
- Preparation & revision of the applicable SOPs in timely manner. Conduct SOP training to the applicable peoples.
- Preparation, storage & archival of the related documents as per GSK policy for documents maintenance.
Candidate Profile
1. Graduate / Post Graduate in Pharmacy preferably with specialization in Quality Assurance (or Post Graduate in science with relevant experience).
2. Minimum 5 to 8 years experience in handling regulatory affairs and dossier management.
Additional Information:
Experience: 5-8 years
Location: Nashik
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 20th November, 2014
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