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

📌 Urgent opening For Process Development Lab- (Tech.Transfer-OSD) (Ahmedabad)
🏢 Intas
📍 Ahmedabad