Ajay Arora
Sr.Manager Quality Control
- Role
- Sr Manager Quality Control at Ipca Laboratories Limited
- Location
- Ratlam, MP, IN
- LinkedIn followers
- 500 followers
About Ajay Arora
To work in an environment that enables me to grow professionally, while being able to…
Experience
Sr Manager Quality Control
Jul 2017 — Present · Ratlam, IN
Responsible for Computer System Validation in the Quality Control Laboratory. Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, EU Annex 11 and GAMP 5 standards. Responsible for Implementation of LES (Laboratory Execution System – a paperless documentation system for Lab) and LIMS software in the QC lab. QMS (Change Control Procedure, Deviations & CAPA etc.) Hands on experience to handle the Quality Control Department and ensuring timely delivery with data integrity compliances. Responsible for supervising analytical work & documentation as per pharmaceutical industry regulations & various other Regulatory Authorities Responsible for cGMP Practice in the plant as per the current international guidelines & A keen communicator with honed analytical, detail orientation and problem solving skills. Expertise in managing training programs time to time. Responsible for qualification of LIMS and LES software as per CSV guidelines.
Education
Kumaun University
B.Sc, Bio
1997 — 2000
Vinayaka Mission's Research Foundation - University
M.Sc., Chemistry
Skills
- Project Audit Trial
- Risk Assessment
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