Job Description: To review batch manufacturing and packaging documentation for solid oral dosage forms. Retrieve electronic scans and review batch records based on cGDP, cGMP, CPC’s SOPs, and FDA guidelines. To perform batch data entry for APR and process validation. Preparation of Annual Product Review / Product Quality Review reports. To review the process validation report. Education Qualifications: B. Pharm or M.sc with 1-4 years of work experience in the FDA regulated / quality assurance industry. Required Skills: Ability to read and interpret FDA guidelines as they apply to documentation reviews. Knowledge of cGMPs related to US FDA and EU EMEA manufacturing environments., Knowledge of manufacturing and packaging processes. Proficiency in Microsoft Word, Excel, graphs/charts, and databases. Ability to communicate effectively. Ability to compile, organize and track documentation. Detail-oriented, with excellent proofreading skills, and the ability to multi-task in a fast-paced environment. Job Type: Full-time Pay: From ₹18,000.00 per month Benefits: Commuter assistance Health insurance Leave encashment Provident Fund Work Location: In person
Responsibilities include, but are not limited to: Ø Regulatory support for assigned projects through product development and lifecycle management of products for US market. Ø Prepare technical documents required for submission of dossier as per country specific requirements. Ø Prepare, develop, and maintain internal Regulatory informational trackers. Ø Review and approve labels inline with US regulatory requirements for assigned products. Ø Respond to consumer inquiries based on approved labels and product information. Ø Coordinate the receipt of raw material regulatory documents from vendors. Ø Preparation of module 1 sections including labelling sections for ANDA products. Ø Perform drug listing of assigned products for US market. Ø Support publishing of ANDA submissions including SPL Creation. Ø Support manufacturing site for commercialization and life cycle management of the approved products. Ø Other projects and duties as assigned by Senior Management Job Type: Full-time Pay: ₹15,000.00 - ₹25,000.00 per month Work Location: In person
Major Responsibilities: Having knowledge of OSD plant machineries (Granulation, Coating, compression and R&D machinery) Perform preventive and corrective maintenance of mechanical equipment (e.g., granulators, tablet presses, coaters, blenders, HVAC systems). Preparation & Execution of Preventive maintenance as per planner. Support installation and commissioning of new equipment and facility expansions. Troubleshoot mechanical issues and implement root cause analysis and corrective actions. Collaborate with cross-functional teams to support R& D operations. Ensure compliance with cGMP, safety, and environmental standards. Prepare and maintain documentation such as SOPs, maintenance logs, and equipment qualification reports. Participate in equipment validation, calibration, and performance qualification activities. Support energy efficiency and cost-saving initiatives through process optimization. Coordinate with vendors and contractors for equipment servicing and upgrades. Qualification : B.E (Mechanical) or DME with 7-9 years of experience in formulation R&D. Job Type: Full-time Work Location: In person