Urgent opening For Process Development Lab- (Tech.Transfer-OSD)

Intas; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Intas is seeking an Executive/Sr.Executive in the Process Development Lab (Tech.Transfer-OSD) to maintain cGMP compliance and drive scale-up, tech transfer and process improvements. The role liaises with PPMC, Production and Purchase teams to manage materials, batch execution, and site transfers.

The ideal candidate has 2–6 years of experience and an M.Pharma qualification, with exposure to QMS, batch reviews, and regulatory interactions.

Qualifications

• 2–6 years of experience in process development, scale-up and technology transfer.
• M.Pharma degree required.

Responsibilities

• Maintain and ensure cGMP compliance.
• Coordinate material management and procurement with PPMC, Production and Purchase teams.
• Execute scale up batches, exhibit batches, commercial validation batches, site transfer batches and launches with cross-functional coordination.
• Initiate and follow up CRF activities (impact assessment & risk assessment) until approval.
• Investigate deviations/OOS/OOT for exhibit batches as per QMS.
• Evaluate batch size, review TID, SBMR and conclude SBMR based on outcomes.
• Review MPCR, PPQP/PPQR & HTSP/HTSR and respond to regulatory queries with required documents.
• Provide technical input to increase batch sizes for commercial product and review annexures.
• Review and provide input on CRF/QMS documents for changes in product/process/batch size/API/PPQR/HTSR; also address deviations for commercial products.
• Review the control strategy document for commercial product.
• Experience in process development, scale-up, and technology transfer is essential.

Education

M.Pharma

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