Virchow Biotech Pvt. Ltd – Urgent Openings for Regulatory Affairs – Apply Now
Virchow Biotech Pvt. Ltd is an ISO 13485:2015 and WHO – GMP certified leading global player in Bio – Pharma sector having more than 15 years of operational experience, situated at Hyderabad. We also have offices located in USA. Innovative, ever motivated Research team and uncompromising manufacturing team in providing quality products are our strength.
We have immediate requirement of Executive or Sr Executive-Regulatory Affairs for VIRCHOW BIOTECH PVT LTD – Hyderabad to the below mentioned position.
- Department: Regulatory Affairs (CDSCO or ROW market)
- Designation: Executive to Sr Executive
- No of Vacancies: 5
- Qualification: M. Pharma or PG in Life sciences
- Experience:2 to 5 years
- Budget: 2.4 lap to 5 lpa
ROLE & RESPONSIBILITY:
1) Responsible for review of executed BMR’s and Protocols
2) Responsible for creations of product codes (PM, RM, SFG) in SAP.
3) Preparation of materials recipes and code extensions in SAP
4) Review of master batch records and MPC’s with respective of MFC and MPC’s
5) Preparation & review of quality assurance SOP’s and review of other CFT’S SOP’s
6) Responsible for Initiation of change controls and review of QAMS elements
7) Training activities
8) Responsible for interact and support with CFT’s including regulatory affairs for the smooth operations at the manufacturing site
9) Ensuring the system compliance
10) Responsible for execution of DSRS software
11) Responsible for involving in dashboard activities
12)Responsible for artwork activities
13) Responsible for preparation of APQR documents
14) Responsible for handling of vendor documents
15) Responsible for handling of product development reports (PDR’s) and technology transfer documents
16)Responsible for partly involving in DC activities
18) Responsible for any activity allocated by HOD/Designee.
REGULATORY SUPPORT AT SITE
19)Responsible to provide all documents for regulatory ANDA filings (stability data, specification, process and cleaning validation reports, QAMS summaries etc…)
21)Responsible for support during post approval/variation filings.
22) Responsible for regulatory complies.
Virchow Biotech Pvt. Ltd
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