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: Quality Assurance Manager (Regulatory and Compliance)
Job Description
(Requirement is for Domestic Market only)
JOB PURPOSE:
Management of site regulatory compliance, internal and external audits, centralized document control (BMR, BPR, SOPs, Logbooks etc.), Print Pack Instructions / Artworks, Technical Terms of Supply and regulatory related investigations at site.
KEY RESPONSIBILITIES:
• Ensure site inspection readiness at all time.
• Ensure zero regulatory sanction. Show Cause Notice(s), warning letter(s) are responded on priority in discussion with Site Quality Head.
• Effective management of FDA inspections to avoid any critical remark(s) in the inspection book.
• Ensure regulatory submissions are done in timely manner. Maintain cordial relations with regulators.
• Ensure timely support is extended for tender business.
• Management of Technical Terms of Supply to ensure they are current & updated timely.
• Contractual agreements are in place & updated on time.
• Ensure Print Pack Instructions / artworks at site are in compliance with regulatory requirements & revised in timely manner.
• Ensure effective management of regulatory documents and BMRs for easy retrieval and retention.
• Ensure 100% adherence to training plan for the self & the team.
• Ensure effective Quality Management System implementation in the area of responsibility.
• Ensure internal audit processes at site are in compliance with regulatory and Quality Management System requirements.
• Ensure timely reporting & effectiveness of the Key Performance Indicators.
• Ensure all the SOPs in the area under control are updated timely and in current state.
• Timely escalation of the issues through departmental performance review meetings / Site Leadership Team meetings & Site Quality Councils.
• Identification & closure of the risks as per the risk mitigation plan in the areas of responsibility.
• Management of local and above site investigation committee meetings.
• Ensure no overdue change controls, deviations, CAPAs in the area of responsibility.
• Annual review and report preparation of the systems under control
Candidate Profile
Candidate must possess at least a Bachelor of Science, Bachelor of Pharmacy, Master of Science, Master in Business Admin/Post Graduate Diploma in Business Administration/Post Graduate Program in Management or Master of Pharmacy in Pharmacy/Pharmacology or equivalent.
At least 12 year(s) of working experience in the related field is required for this position.
Preferably Managers specializing in Quality Control/Assurance or equivalent. Job role in Quality Control/Assurance or equivalent.
1 Full-Time position(s) available.
Additional Information:
Experience: Min. 12 years
Location: Nashik
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 15th June, 2014
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