Sr. Officer/ Executive - RA
1 Nos.
80641
Full Time
3.0 Year(s) To 6.0 Year(s)
3.00 LPA TO 7.00 LPA
Production / Quality / Maintenance
Pharma/Biotech/Clinical Research
B.Pharma - Pharmacy; B.Sc - Chemistry; M.Pharma - Pharmacy; M.Sc / MS Science - Chemistry
Job Description:
Job Description:
Position: Sr. Officer/ Executive - RA
Location: Daman
Experience: 3 to 6 Years
Industries: Pharma
Responsibilities:
- Maintaining compliance with ISO 13485, MDD, and MDR requirements.
- Preparing technical and device 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
- Artwork approvals
- Risk management, clinical evaluation, and PMS for class Is, II and class III products
- Design and development support for regulatory, customer inputs, product specifications,verifications and validations
- Leading Regulatory, Customer and Certification audits
- CAPA management
- Coordination with marketing, development, purchase, QC and stores on day-to-day basis for requirements and support.
- Training to sub-ordinates on GMP, GDP, QMS
- Co-ordinating with local FDA and CDSCO for various permissions.
Required Skills:
- Profound knowledge of ISO 13485, ISO 9001, ISO 14001 and Technical Documentation of Medical Device.
- 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 7.00 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.