Sr. Executive - RA
1 Nos.
87303
Full Time
7.0 Year(s) To 8.0 Year(s)
7.00 LPA TO 9.00 LPA
Production / Quality / Maintenance
Pharma/Biotech/Clinical Research
B.Pharma - Pharmacy; B.Sc - Chemistry; M.Pharma - Pharmacy; M.Sc / MS Science - Chemistry
Job Description:
Position: Sr. Executive - RA
Location: Daman
Experience: 7 to 8 Years
Industries: Pharma
Responsibilities:
- Maintaining compliance with Dossiers, ISO 13485, WHO/GMP requirements.
- Preparing technical and Drug master files
- Preparing and compiling documents for registration to various countries.
- Reviewing and updating of documents w.r.t various regulatory requirements
- Reviewing and updating of documents w.r.t various applicable standards
- Risk management, clinical evaluation, and Pharmaco-vigilance.
- Leading Regulatory, Customer and Certification audits.
- CAPA management.
- Training to sub-ordinates on Regulatory.
- Co-ordinating with local FDA and CDSCO for various permissions.
Required Skills:
- Profound knowledge of USFDA and EU Submission, ISO 13485.
- Good Understanding of regulations, guidelines, procedures, and policies relating to development,registration and manufacturing of drug-device to expedite the submission, review and approval of global applications.
Required Qualification: - B.Pharm/M.Pharm/B.Sc/M.Sc
Salary :- Upto 9.00 LPA
If you are interested for this opening please send updated resume on same mail with following details.
Total No. of Years Experience :-
Current CTC :-
Expected CTC :-
Notice Period :-
Key Skills :
Company Profile
The company is into manufacturing of high quality IUDs.
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- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.