Intas
Urgent opening For Process Development Lab- (Tech.Transfer-OSD)
Skills
2 months ago
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Important information
Contract type:
Permanent
Salary:
₹500,000 – ₹1,000,000 / year
Location:
Ahmedabad, Gujarat, India
Work mode:
Onsite
Published on:
12 August 2026
What they need
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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