Sr. Executive - RA

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 :-

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.

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