Otsuka Pharmaceutical India Private Limited (OPI) is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and Mitsui & Co. Ltd., Japan, for Infusion Business in India and Emerging Markets. We primarily manufacture & market products across multiple markets and therapeutic segments. Being a leader in intravenous nutrition products, we are committed to being the best partner of patients and healthcare professionals in the field of clinical nutrition..
Otsuka Pharmaceutical Walk-in Interview
- Qualification: B.Pharm, M.Pharm
- Experience : 02-07+years
- Department: Regulatory Affairs
- Job Location: Ahmedabad
- Role: Process Incharge
- Salary: 3-6 Lacs P.A.
- No. of Openings: 03
Time and Venue:
23 September , 9.00 AM – 2.00 PM
Otsuka Pharmaceutical India Pvt. Ltd., 21st Floor, B Block, Westgate, near YMCA Club, SG Highway, Ahmedabad-380015, Gujarat. Tele. – 079-66216000
Contact – Himanshu ( 7984556557 )
Job description:
Role & responsibilities:
- Dossier preparation/review as per country specific guideline/CTD guideline
- Timely query response submission to Distributor/ MOH
- Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement)
- Preparation, review & release of artworks & sales order as per country approval
- Variation documents preparation and filing as per country requirements
- Timely dispatch of tender documents to country/parties as per deadline
Preferred candidate profile:
- Should be able to review & interpret the requirement as per country specific/ tender guideline
- Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master file, BMR, APR etc.
- Should be able to handle team of two members
- Should be able to communicate with relevant functions for procurement of required regulatory documents
- Should be able to communicate with relevant counter part at country
- Preferred Immediate joiners
