Quality Assurance (Sr Executive) For Pharma
- BVR People
- 4 to 6 Yrs
- Bengaluru
- 3 years ago
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Job Description
Roles and Responsibilities
Job Title: Quality Assurance (API Bulk Drugs)
Company: Leading Pharma API Company in Bangalore
Designation: Executive to Senior Executive
Reporting to: Manager
No. of Positions: 2
Division: API Bulk drugs
Department: Quality Assurance
Job Location: Bangalore
Qualification: MSc/M.Pharma/M.Tech (Full Time only )
Years of Experience: 4 to 6 Years
Salary Range: 6 LPA
Contact person: Mr.Zabi Moghal
Mobile: 8105301***
Email: za*i@bv**c.com
Job Responsibilities:
1. Fill in Questionnaires as part of Vendor Qualification System and other relevant documents as applicable. Handling of customer queries.
2. Implement and maintain the quality systems at site as per corporate policy and statutory regulations. Monitor the process of analytical lab for assurance of GLP practices.
3. Review and authorize documents such as SOP, process development plan, specification, STP and analytical reports.
4. Review of internal quality audit report and evaluate FLP compliance.
5. Review and approval of quality agreements with customers and vendors.
6. Regulatory affairs responsible for activities related to dossier submission for test license, NOC and other regulatory documentation.
7. Regulatory/Statutory bodies/ Interdepartmental as and when required.
8. Thorough knowledge of all pharmacopeias. Analytical documents review.
9. To upgrade documents / system as per requirement of cGLP. Review of analytical Records.
10. Monitoring, Logging, Investigation, Tracking, closure & Trending of OOS & OOT.
11. Initiation of Change control, Deviation, Risk Assessment & CAPA.
12. Vendor Audit Management: Preparing Audit agenda, suppliers pre-audit questionnaire, Audit Schedules, audit conduction, Vendor Audit Reports preparation, executions and technical agreement.
13. Planning, Execution and compliance for Internal Audit.
14. Review and approve Analytical method development records, Stability protocols & reports, analytical reports. Review of Method validation and cleaning validation documents.
15. Planning and execution of Training.
16. Issuance & Review and approval of finished product, raw material, packing material & stability analytical Raw data.
17. Review of RM, PM Vendor Documents. Handling of Raw material vendor documentation. Review and handling of Halal Kosher documentation
18. Approval of documents related to Good manufacturing practices on deputation of head of the department (Viz. Specification, MOA, SDS, COA &Declaration etc.).
19. Handling of SAP system for the vendor documentation and Inventory transactions.
20. Compilation and review of data for regulatory submission (in domestic market and international) (viz CMC data in CTD format) by coordinating with Regulatory and marketing team.
21. QA rounds of Quality control for GLP compliance.
22. Dispatch activities and to provide COAs as per customer requirement by coordinating with QC.
23. Handling Audit & compliance to customer / regulatory audits, coordinating with Marketing & Regulatory team.
24. Vendor document Requirements request & follow-up with Purchase Department. Any other job assigned by HOD.
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Quality Assurance (Sr Executive) For Pharma
Contact Details:
Company: BVR People ConsultingLocation(s): Bengaluru
BVR People
Company ProfileBVR People ConsultingBVR people consulting committed to help Organisations to realise and develop their full potential in order to compete in the present day globalised and technology driven business environment. BVRPC invigorates the key components of organizations - The People and...
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