QA

As per the batch manufacturing procedures and packing protocols, samples such as in-process samples, finished product samples, stability samples, control samples, cleaning samples, and other samples should be collected and submitted

Having Injectable Experience of Analysis of raw material. In-process, Finish products, Stability testing, Process validation. Hands on Experience of HPLC, GC, LBPC, Osmometer, KF Auto titrator and UV - Visible spectrometer, LIMS,QMS,Participate in Lab incident , OOS, OOT, Analysis of deviation.

Intas is expanding and evolving its Biopharmaceutical capabilities. We invite ambitious professionals to be a part of its future growth story.

Handling HPLC. Compilation of Raw Data for Review. Sampling and Release of Raw material and Packaging Mate. Analysis & preparation of water Trends.

Experience of formulation plant and knowledge of GLP & GDP. Should have knowledge of Microbiological testing, Environmental monitoring, Water system analysis, HVAC validation, QMS

Ensures that justified extension requests are made before the investigation deadline and that the investigations and CAPAs are closed within the required timeframe. Acts as a guardian of metrics by carrying out periodic follow-ups regarding investigations and CAPAs opened with internal and external partners. 

Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor, co-auditor for outsourced parties CROs, Service Providers, Vendors, Affiliates & Partners etc., associated with Sun Pharma

Expertise in designing, executing, and reviewing cleaning validation protocols. ensuring compliance with cGMP. EMA. and other global regulatory requirements. Specializing in stability studies, regulatory compliance, and quality assurance oversight. Managing stability programs in alignment with ICH guidelines

Ensure that Bulk Viral Antigen production adheres to GMP standards on the shop floor, including line clearance, dispensing, and preparation processes. Examining and approving batch records, standard operating procedures, project plans, customer verification, and APS documents.