EXPERIENCE IN DOWNSTREAM PROCESS WITH RESPECT TO
HANDLING OF CHROMATOGRAPHY SYSTEMS, COLUMN PACKING AND UNPACKING, TFF SYSTEM, PREPARATION OF APQR.
- Required Experience: 3-7 years.
- Qualification: M.Sc Biotechnology/M.Sc Biochemistry/M.Sc Microbiology / B.Pharmacy / M.Pharmacy.
- Note: Downstream Experience in Biologics/Vaccines is preferable.
Shortlisted Candidates will get a call from HR Department
9121514444/8367563333
100% FREE PLACEMENT
BVR SOLUTIONS | WE’RE HIRING
BELOW POSITION FOR BIOLOGICS PLANT BASED @ HYDERABAD.
- DEPARTMENT: RA (REGULATORY AFFAIRS)
- EXPERIENCE : 10-15 YEARS
- POSITION : DY. MANAGER/MANAGER
- SALARY : 10 to 12 LPA
- 100% FREE PLACEMENT
JOB DESCRIPTION:
01. HAND ON EXPERIENCE IN REGULATORY SUBMISSIONS PREDOMINANTLY FOR BLOOD PRODUCTS AND BIOLOGICS.
02. REVIEW OF APPLICATIONS FOR NEW PRODUCTS MANUFACTURING LICENSES AND RENEWALS.
03. EXPERIENCE ON PROCEDURES FOR APPLICATION OF NEW DRUGS (NOC’S AND TEST LICENSES).
04. MONITOR OF CERTIFICATES (COPPS, GMP, GLP, WHO-GMP AND FSC PRODUCTION CAPACITY
AND PERFORMANCE CERTIFICATE) RENEWALS AND APPROVALS UP TO DATE.
05. REVIEW OF TENDER CERTIFICATE.
06. CO-ORDINATE WITH DRUG CONTROL AUTHORITY PERSONNEL FOR LICENSE APPROVALS.
07. REVIEW OF DOSSIERS.
08. SUBMISSION OF SAMPLES AND DOCUMENTS TO NIB, NOIDA FOR TESTING.
09. UPDATION OF THE NATIONAL AND INTERNATIONAL LEGISLATION, GUIDELINES, AND CUSTOMER PRACTICES.
10. APPROVAL OF ARTWORKS.
11. UNDERTAKE AND MANAGE REGULATORY INSPECTIONS.
12. RESPONSIBLE TO HANDLE THE SUGAM PORTALS AND ONLINE DRUG LICENSING SYSTEM AND
NATIONAL SINGLE WINDOW SYSTEM (NSWS).
13. COMPLETE KNOWLEDGE ON ROW AND EU MARKET REGISTRATION.
14. QUERY RESPONSE SUBMISSION RECEIVED FROM VARIOUS Mон.
15. EXPERIENCE IN TRADEMARK LICENSE.
16. MANAGING THE TEAM FOR COMPLETION OF REGULATORY WORKS.
17. COORDINATION WITH QUALITY AND OPERATION FUNCTION FOR FRAMING/AVAILABILITY THE DOCUMENT AS PER THE REGULATORY EXPECTATION.
INTERESTED CANDIDATES SHARE THEIR UPDATED RESUMES TO
SHORTLISTED CANDIDATES WILL GET A CALL FROM HR DEPARTMENT
9121514444 / 8367563333
WORK LOCATION: GENOME VALLEY, HYDERABAD
WEEK-OFF : ALTERNATE SATURDAY
SHIFTS : ROTATIONAL
BUS ROUTE : UPPAL, MIYAPUR, ECIL, GANDIPET, CHINTAL, BOWENPALLY.
BENEFITS: FREE TRANSPORTATION, SUBSIDIZED CANTEEN
EVERY 2nd & 4th SATURDAY HOLIDAY.
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