Great job opportunity for M. Pharm or PG in Life science at Virchow Biotech Pvt Ltd

VBPL is a highly experienced and reputable player in the biopharma sector with a strong focus on quality and innovation. Being ISO 13485:2012 and WHO-GMP certified are both impressive achievements, and it shows that VBPL is committed to meeting the highest standards of quality and safety in its operations.

Having a motivated research team and a dedicated manufacturing team is also essential for success in the biopharma sector, where cutting-edge research and development must be coupled with reliable and efficient manufacturing processes to bring high-quality products to market.

Post: This is a job posting for an Executive or Senior Executive role in Regulatory Affairs at VIRCHOW BIOTECH PVT LTD in Hyderabad.

Qualifications & Experience: The job requires a candidate with a M.Pharma or PG in Life Sciences and 2-5 years of relevant experience.

The candidate should have a strong understanding of regulatory compliance and support at the manufacturing site, with experience in the pharmaceutical industry. The job requires attention to detail, the ability to work independently, and excellent communication and interpersonal skills. The successful candidate should also have experience with SAP and DSRS software, as well as the ability to handle multiple tasks simultaneously.

Job description:

The key responsibilities include:

1. Reviewing executed BMR’s and protocols.
2. Creating product codes (PM, RM, SFG) in SAP.
3. Preparing materials recipes and code extensions in SAP.
4. Reviewing master batch records and MPC’s with respect to MFC and MPC’s.
5. Preparing and reviewing quality assurance SOP’s and reviewing other CFT’s SOP’s.
6. Initiating change controls and reviewing QAMS elements.
7. Conducting training activities.
8. Interacting and supporting CFT’s including regulatory affairs for smooth operations at the manufacturing site.
9. Ensuring system compliance.
10. Executing DSRS software.
11. Involving in dashboard activities.
12. Handling artwork activities.
13. Preparing APQR documents.
14. Handling vendor documents.
15. Handling product development reports (PDR’s) and technology transfer documents.
16. Partly involving in DC activities.
17. Handling any activity allocated by HOD/Designee.
18. Providing all documents for regulatory ANDA filings (stability data, specification, process and cleaning validation reports, QAMS summaries, etc.).
19. Providing support during post-approval/variation filings.
20. Ensuring regulatory complies.

Interested candidates can send their resumes to raghu@virchowbiotech.com before the last date of 20th May, 2023.