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8.0 - 12.0 years
0 Lacs
maharashtra, tarapur
On-site
As a Quality Assurance Manager, your role involves ensuring quality standards for all products and manufacturing activities. Your key responsibilities will include: - Ensuring GMP compliance throughout the facility - Organizing, educating, and executing activities as per Quality Assurance objectives - Handling customer audits - Releasing or rejecting APIs and Intermediates - Ensuring workforce motivation and alignment with Company objectives - Handling OOS investigation - Ensuring compliance of QMS/GMP/GLP - Managing Regulatory audits and compliance (USFDA/EU/TGA/WHO/Cofepress/KFDA) - Knowledge and handling of Risk assessments, cleaning validation, Preparation of site master file, Quality Ma...
Posted 1 week ago
4.0 - 8.0 years
0 Lacs
gujarat
On-site
As an Officer/Senior Officer in the Quality Control department located in Kandla, you will be responsible for handling troubleshooting of HPLC and GC analysis using Chromeleon Software. Your primary task will be to ensure that all work is carried out in compliance with SOP/STP/CSOP/GTP, including adhering to GLP and EHS norms, while maintaining laboratory discipline. It will be your duty to review and maintain all related log books and wet Laboratory records in a timely manner. Your role will also involve overseeing the completion of daily activities and targets, managing HPLC columns, and handling software such as LIMS, LMS, IMS, and SCM. You will be expected to identify gaps in SOPs, analy...
Posted 2 months ago
3.0 - 8.0 years
3 - 6 Lacs
Navi Mumbai
Work from Office
Experience: 3-8 years Location: Navi Mumbai Role & responsibilities Batch analysis and wet analysis. Should have expertise in analytical testing as per in house method / pharmacopoeia. Sound knowledge and handling of HPLC (Preferably Chromeleon software), Dissolution, UV spectrophotometer and other Analytical instruments. Should have well verse with ICH guidelines, cGMP, Data integrity. Should have knowledge of QMS related activity (i.e. Deviation, incidence, Change control, OOS, OOT). Knowledge of wet testing as per pharmacopeia. Hands on testing batch analysis using various techniques like HPLC, GC, Dissolution, UV, FTIR, Friability, Disintegration etc.
Posted 5 months ago
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