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Vacancy for Trainee-Regulatory Affairs in Bliss GVS Pharma

 

Clinical courses

 

Clinical courses

Bliss GVS Pharma is a Public Limited Company, with more than 28 years of expertise in developing, manufacturing and marketing of Pharmaceutical Formulations in various dosage forms. Besides the Indian market, we are exporting our products to more than 60 countries across the globe ranging from South East Asia, Africa, Russia & CIS and Latin American Countries with a sales revenue for last year was more than 350 Crore Rupees.
Our manufacturing plants are at located Palghar, Daman and Ambernath. Head office is located at Andheri-East.
We are have a aggressive expansion plans for Pharmemerging Markets.
Refer to our website: Bliss GVS Pharma Ltd.

Post: Trainee-Regulatory Affairs

Job Description:

  • Preparation of Dossier in ROW Markets
  • Reviewing documents received from QA/QC & maintaining records
  • Searching guidelines of registration for different countries like Europe, US, Asian Countries, South Eastern countries
  • Reviewing data (BMR, MFR, Stability data, specification Data) received from LL locations (Loan License)
  • Co-ordinating with our plant and LL locations for samples
  • Printing & Filing of dossier & data
  • Arranging & checking art-works of drug products for technical accuracy, registration
  • Collecting additional data required by Regulatory Authorities for the queries, related to Pharmaceutical and Pharmacological documents
  • Reviewing of documents received from public labs
  • Preparation of data like Stability, Specification & Standard Test Methods, Standard Operating Procedure, Certificate of Analysis.
  • Visiting Mfg. Plant, LL Units & Contract manufacturing units for the data required for submission
  • Preparing Product registration status for all countries (country wise / person wise)

Minimum Skills Required:


  • Proper understanding of Pharmaceutics and Pharmacology
  • Gen of various sites on Internet related to pharma field such as Pub Med, clinical trial, Google search, RX List.com
  • Strong analytical skills for reviewing the documents
  • Excellent interpersonal, verbal, and written communications skills
  • Good computation Skills
  • Logical Interpretation of Data
  • Sound knowledge of MS-OFFICE
  • Curiosity & Attentiveness in Learning
  • Engrossment in job related work
  • Punctual, Sincere and Systematic approach
  • Ability to work as a team
  • An eye for detail

For More Info Go to Next Page...

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Eligibility Criteria:
B. Pharm
Fresher
Only Male candidates are required
Residing in and around Andheri (Mumbai)
Candidates basically from Mumbai & suburban origin only will be considered
Computer Efficacy in MS-Office and Internet

Additional Information:
Qualification: B.Pharm
Experience: Fresher
Location: Andheri (East), Mumbai
Industry Type: Pharma
Functional Area: DRA
End Date: 14th March, 2014

Send your resume at: careers@blissgvs.com

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