Executive/Senior Executive

6 days ago


Bengaluru, Karnataka, India Strides Pharma Science Full time ₹ 8,00,000 - ₹ 12,00,000 per year

Good Documentation Practices, Compliance for Standard Operating Procedures, Quality Management Systems shall be followed.

Review and understanding of product related technicalities from Internal sites to facilitate smooth transfer of products to External CMO'S.

Co-ordination and collection of technical documents from internal sites.

Sharing the Tech pack (MFR, MPR, Spec/STP, BMR, BPR, Tool drawings layouts etc.) to CMO'S.

Review of Master documents before initiating validation batches at CMO locations.

Handling of Investigation related to OOS/OOT/Deviation occurred/reported for New Products and Site Transfer Projects.

Conducting Feasibility trials/ Scale up trials.

Cost improvement program for identified product, to change the formula and improvise the process as required.

Handling of Product Robustness Projects and related activities like conducting the trials at R&D, Execution and Monitoring of Optimization batches and Registration/Commercial batches for PR projects.

Handling of Trouble shooting to improve the product quality attributes.

Review of APQR, RCI, CAPA's, PDR, and other related documents.

Handling of QMS events (CC/Deviations) in Trackwise.

Ensure Test license availability at R&D & Plant.

14.    Ensuring RM availability for execution of lab trial batches, PO/PE/Scale up batches and monitoring the batches during execution.

Review of Tooling and Change parts layouts.

Preparation & Review of Trial Reports, and Investigational Summary Report's.

17.    Preparation and Review of Documents i.e. MFR's, BMR's, BPR's, Protocols/Reports for Trial/Feasibility, PO and New Products, various batch sizes and subsequent revisions of all kinds.

Review & Approval of PVP & PVR,

Preparation and review of QRM.



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