QA

Audit Response writing skill, Audit handling skill. Current Guideline assessment and compliance. Gap Assessment to overall Regulatory Compliance. Proficient in risk assessment, cleaning procedure optimization. Adept at collaborating with cross-functional teams to maintain robust cleaning validation programs.

Have good exposure in Plant Maintenance & Instrumentation related work in sterile facility. Have good exposure in Sterile IPQA & Sterile Qualification Related activity.

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.

 IPQA Mfg. & Packing, Shop floor activities, Review of equipment audit trails, BMR, BPR review, line clearance. Process Validation, equipment, Utility qualification.

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.