Aurobindo Pharma has identified international operations, catering to over 100 countries, as a major engine of growth and expanding global network of marketing and manufacturing operations across countries like China, Brazil, Japan, Netherlands, South Africa, Thailand, UK, USA, Russia, Netherlands and many more which will further expand its international reach.
Post: Manager/ Sr. Manager-QA -Audit and Plant Compliances
Job Description:
1. Lead of the Plant document cell, Analytical assurance and Plant regulatory function.
2. To review and get approval of BMR, BPR in coordination with IPQA and production team.
3. To review all the documentation related to regulatory submission and submits to regulatory department.
4. To review all the Quality control related SOPs, Specifications, STPs & GTPs for their compliance as per SOP, cGMP and respective regulatory requirements.
5. To perform Gap analysis at regular interval to identify any gaps in quality systems with respect to change in system/ corporate procedures, changes pharmacopeia/ regulatory guidelines etc. and prepare & implement actions as per guidance of Head – QA.
6. To establish good documentation and filing system for easy retrieval & maintenance of all quality records.
7. To coordinate with purchase department for vendor qualification procedure and to maintain all required records/ reports for the same. This also includes qualification of outside testing facility. To ensure that requalification procedure is also done as per schedule.
8. To coordinate with commercial department for applying for various product/manufacturing permission/ license from DCGI or local FDA. To maintain updated all such permission / license list at plant.
9. Review and response to plant related regulatory queries within stipulated time period.
10. Review and approval of Quality Notifications like Change control, Deviations and CAPA etc.
Additional Information:
Experience: 10-14 years
Location: Hyderabad
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 10th Dec, 2011
E-mail your resume to mitalee.kar@aurobindo.com
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