Quality Assurance Officer Resonant Pharmaceuticals

3.0 - 7.0 years

0 Lacs

gujarat

On-site

As a Quality Assurance Specialist, your responsibilities will include reviewing all Master Production and Control Record (MPCR) and Batch Packing Records (BPR), as well as Standard Operating Procedures (SOPs). You will need to meticulously review specifications and testing procedures for starting materials, packaging materials, in-process products, finished products, working standards, and stability (Shelf life). Additionally, you will be tasked with reviewing Out-of-Specification (OOS) investigation reports and participating in investigations related to complaints, vendor audits, external testing laboratories audits, and the subsequent Corrective and Preventive Actions (CAPA). You will also review deviations, change controls, non-conformances, incidences, returned goods, and CAPAs. Your role will involve overseeing the destruction of starting materials, in-process materials, packaging materials, and finished products, as well as conducting the Annual Product Quality Review (APQR) and preparing associated reports. You will participate in the review of protocols and reports for user requirement specifications, qualifications, validations, Risk Assessment, and other studies at the site. Furthermore, you will be responsible for ensuring the retention and maintenance of records, reviewing equipment lists, drawings, preventive maintenance, and calibration schedules. You will provide clearance for various manufacturing and packing activities during day-to-day operations, conduct timely sampling/Acceptable Quality Level (AQL) checks at different stages, and perform sampling during process validation, Hold time studies, and cleaning validation. In-process checks will be conducted, and relevant records will be maintained on the shop floor. This is a full-time position with benefits such as Provident Fund, day shift or rotational shift schedules, performance bonuses, yearly bonuses, and the work location is on-site.,

Posted 2 days ago

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Site Process Engineering Lead and Chemist Smilax Laboratories Limited

5.0 - 15.0 years

0 Lacs

andhra pradesh

On-site

You will be responsible for leading the Site Processing Engineering team in a Medium to large Generic API company. With a minimum of 10-15 years of experience, you should have a strong background in solvent recovery enhancement, troubleshooting scale-up issues, and continuous improvement of running molecules in the plant. Your expertise should include time cycle reduction, improving process economics, utility cost reduction, technology transfer, and a proven track record of leading operational excellence programs. As a Process Chemist, you will join our team with a focus on Plant based Process Development. With a minimum of 5-8 years of experience, you will work on Process Development, Yield Improvement, and Cost Reduction to meet industry benchmarks. Your responsibilities will include troubleshooting plant process issues, OOS investigation, CAPA development, and handling complex chemistry improvement projects.,

Posted 5 days ago

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