Formulation Research Scientist _Injectables _ Manager_Hosur

2 days ago

Hosūr, India BVR People Consulting Full time

Greetings

We are looking for Formulation Research & Development Scientist - Injectables for a leading Pharmaceutical company based at Hosur location.

Responsibility:

  1. Develop robust formulations and processes for general products to various markets such as Regulatory, Semi-regulatory, ROW, and Domestic with application on QbD as needed.

  2. Monitoring and supporting the formulation team for the completion of allocated projects within the timelines by trouble shooting the concerns involved.

  3. Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet timeIines.

  4. Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports).

  5. Author technical documents including Product Development Report, Quality Overall Summary and other relevant documents for filing purpose.

6 Interaction with API/Excipient manufacturers, CROs and CMOs as needed.

  1. Interaction with external testing laboratories as needed.

  2. Work proactively with other cross-functional groups to execute all product related activities such as Manuticturing and Packaging master records, SOPs and protocols etc.

  3. Co-ordination with other Dept. like Purchase. QC/QA, RA, ADD, Production Eng. etc. related to product development activity.

  4. Review SOPs, as well as appropriate documentation and test results for accuracy and coin pleteness and coinpl iance with SOPs/GM P requirement.

11 . Coordinate with RA for fiI ing AN DAs and addressing deficiencies; provide relevant documents to Regulatory Affairs in a timely man ner for ANDA fil ings and Supplements filing.

1 2. Review of batch records, process characteri xation reports, validation reports and investigation

reports.

Interested Candidates Kindly share your updated cv to

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