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: AVP-QC & Micro
Job Description:
1. To ensure effective implementation of CGMP, GLP, organization policies, safety, Health & Hygiene policies, including all relevant SOPs and discipline in the quality control laboratory area to maintain healthy work environment
2. Preparation/review/approval of SOPs, Specifications, STPs & all other such documents / protocols related to quality control analytical laboratory in coordination with QA.
3. To be the part of / designate some competent person for audit and qualification of vendor for incoming materials (raw materials & packing materials) & outside testing facilities in coordination with purchase and QA department.
4. Planning and monitoring for timely sampling and analysis of Incoming materials, which includes raw materials, packing materials and product contact materials (consumable materials). To ensure that all the relevant documents are completed and maintained online.
5. Planning and monitoring for timely analysis of In-process and finished products samples, which also includes validation samples. To ensure that all the relevant documents are completed and maintained online.
6. Review of Quality Control - Analytical Portion of TTD of various new products submitted by R&D. To plan for preparation of various specifications, Method of Analysis (Standard Test Procedures), Work Sheets, etc., and to finally approve the same for implementation.
7. To plan and monitor for the timely completion of the relevant documents/data/records for ANDA submission. To coordinate with QA/RAD/R&D for any correction or revision in such documents as per the recommendations.
Additional Information:
Experience: 18-26 years
Location: Anywhere
Education: M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QC
End Date: 15th August, 2011
E-mail your resume to mitalee.kar@aurobindo.com
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