Ind Swift Laboratories Ltd.
Established in 1995 Ind-Swift has fast evolved towards a business model that is focused on deep-rooted domestic presence and leveraged on high-value mature regulated markets along with considerable growth in emerging markets:
* Ind-Swift Laboratories Ltd. (Manufacturer of APIs)
* Ind-Swift Laboratories Inc. (US Subsidiary)
With manufacturing sites at 6 different locations across India and an independent State-of-the-Art R&D Centre, the Group has embarked upon a journey to establish itself as reliable partner in the Global Pharmaceutical Industry. In house capabilities for Development of APIs, Finished Dosage forms, Non-Infringing Process & World Class facilities for Contract Manufacturing are the inherent strengths
* Ind-Swift Laboratories Ltd. (Manufacturer of APIs)
* Ind-Swift Laboratories Inc. (US Subsidiary)
With manufacturing sites at 6 different locations across India and an independent State-of-the-Art R&D Centre, the Group has embarked upon a journey to establish itself as reliable partner in the Global Pharmaceutical Industry. In house capabilities for Development of APIs, Finished Dosage forms, Non-Infringing Process & World Class facilities for Contract Manufacturing are the inherent strengths
Job Title: Senior Officer / Executive
No. of Posts: 2
Remuneration: 3,50,000 – 4,50,000 P.A.
Nature of Work:
- Preparation/review of European Drug Master Files and timely information to customers for changes wrt variation filing.
- Preparation/review of CEP dossier and revision report.
- Tracking of all marketing authorization application wrt DCP procedure, MRP procedure and National procedure.
- Preparation, review and submission of DCGI Application (Form 44), Test license (Form 29) and local license Application for obtaining the manufacturing licenses of APIs.
- Preparation and review of all agency communication letter e.g. Letter of access, CEP certificates and other declaration letters.
- Review of all TDPs and DCGI documents.
- To assist the team in drafting the customer and Agency query response.
- Support to all team members wrt Regulatory documents, compilation and submissions.
- Timely submission of documents and response to marketing department for the customer development.
Qualifications:
- UG: B.Pharma – Pharmacy, B.Sc – Any Specialization
- PG:MS/M.Sc(Science) – Chemistry, Organic Chemistry, M.Pharma – Pharmacy
- Doctorate:Doctorate Not Required
