THE VIRCHOW GROUP with an operational experience of over 4 decades has a global footprint in over 100 countries supporting about 3,500 employees with an annual turnover of over $600 million. The Virchow Group has a diversified business portfolio ranging from Biogenerics, Pharmaceuticals, Medical devices, and APIs. The group is the largest producer of Sulfamethoxazole and Ranitidine Hydrochloride in the world.
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
Salary: 2.4 lap to 5 LPA
Roles & 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.
Interested candidates can share with the below mentioned mail-Id.
raghu@virchowbiotech.com
Regards,
P.Raghurami Reddy
HRD
Virchow Biotech Pvt. Ltd
Hyderabad.
Mob-9642996045
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