Granules India Hiring In Regulatory affairs Department

Granules India Limited Released Job Openings On 16-12-2021.Granules India Limited is an Indian pharmaceutical manufacturing company based in Hyderabad, India. Granules manufactures several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and rest of the world markets.

Vacancy Details:

Granules India Limited Recruiting Master’s degree or equivalent in Pharmaceutical or Chemistry or Pharmacy or Life Sciences Candidates with 03-08 Years of Experience for Analyst Position.Complete Details for the Analyst as follows.

Important Details :

• Location :Gagillapur-Hyderabad
• No of Vacancies:NA
• Details of Salary:Not Disclosed by Recruiter
• Opening date for online Application:16-12-2021
• Mode of application :Online
  
• How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps

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Job Description/Skills Required

1. Provide support for Compilation of dossiers (Drug master files) and submitting to various regulatory agencies.
2. Preparation of dossiers as per USFDA, EDQM, ASMFs, Heath Canada, WHO and other regulatory agencies dossier requirements.
3. Preparation of responses to queries received from customers and regulatory agencies.
4. Experience in change controls evaluation.
5. Preparation of DMF Amendments/CEP revisions/Other DMF updates to support life cycle management of product.
6. Hands on exposure in pharma ready eCTD software handling for US, Europe and Canada markets requirements.
7. Ensuring the PDF properties of Dossiers for uploading into pharma ready eCTD software based on regulatory market requirements for converting PDF document in to XML backbone. Further the complete dossier is zip filed and submitted in to ESG gateway of USFDA and CESP portal of EU agencies.
8. Liaising with internal customers and stakeholders to ensure coordination of all projects.
9. Provide support for continuous improvement in existing procedures/practices/compliance of department.
10. Provide support in the overall management of the Regulatory affairs department and create a healthy environment of teamwork and empowerment, and promoting the values of creativity, integrity, excellence, perseverance, flexibility and respect.

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