Experience
2 - 6 yrs
Salary (CTC)
₹5L - ₹10L
Job Location
Ahmedabad, India
Vacancy
3
Designation
Process Development Scientist
Job Type
ONSITE
Job Description
Role & responsibilities
- To maintain and ensure the cGMP compliance.
- Material management & machine change parts procurement process in co-ordination with PPMC, Production & Purchase team.
- To execute the scale up batches, exhibit batches, commercial validation batches/ site transfer batches/ commercial launch batches/ trouble shooting batches with co-ordination with PPMC team & Production team.
- To initiate and follow up for CRF activity (i.e. Impact assessment & Risk assessment) till approval of CRF.
- To initiate & investigate the deviation/OOS or OOT for exhibit batches as per QMS system.
- To evaluate batch size, review of TID, review of SBMR for scale up batches and conclude the SBMR based on scale up batch outcomes.
- To review the MPCR, PPQP/PPQR & HTSP/HTSR.
- To Review & response the regulatory queries and ensure the availability of all relevant documents required for response.
- To provide technical input to increase batch sizes for commercial product & review the annexures of the same.
- To review and provide technical input in commercial CRF/ QMS documents for any changes in product/ process/ batch size/ API/ PPQR/ HTSR etc. Also review & provide input in the Deviation/ OOS/ OOT for commercial products.
- To review the control strategy document for Commercial product.
- Experience in process development, scale-up, and technology transfer is essential.
Job Specifications:
Experience: 2 To 6 Years
Education: M.Pharma
Department: Process Development Lab (Tech.Transfer-OSD)
Designation: Executive/Sr.Executive
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