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2.0 - 7.0 years
2 - 7 Lacs
Jadcherla
Work from Office
Analytical Method Development & Validation : Develop and validate analytical methods for assay, dissolution, related substances, and content uniformity as per ICH guidelines. Troubleshoot and optimize analytical methods for new and existing OSD products (tablets, capsules, etc.). Routine Analysis & Documentation : Conduct analysis of raw materials, in-process samples, and finished products. Prepare and review protocols, reports, method validation documents, and specifications. Stability Studies : Execute and monitor stability studies as per ICH guidelines. Generate stability data and interpret results to support product registration. Instrumentation Handling : Operate and maintain sophisticated analytical instruments like HPLC, UV, FTIR, Dissolution Apparatus, GC, etc. Ensure proper calibration and upkeep of instruments. Regulatory Compliance : Ensure all analytical activities comply with GLP/GMP and regulatory requirements. Support regulatory submissions (ANDA, CTD, eCTD) with analytical documentation. Cross-functional Support : Collaborate with formulation, regulatory, QA, and production teams to support product development lifecycle. Participate in technology transfer and scale-up activities. Key Skills : Sound knowledge of analytical chemistry and pharmaceutical analysis. Hands-on experience with HPLC/GC/UV and dissolution testing. Familiarity with ICH guidelines and regulatory requirements for US/EU/ROW markets. Good documentation practices and data integrity awareness. Ability to work in a fast-paced, cross-functional environment.
Posted 2 months ago
3.0 - 8.0 years
2 - 5 Lacs
ahmedabad
Work from Office
Unison Pharmaceuticals Pvt Ltd is urgently seeking talented ADL Scientists for LCMS - Nitrosamine Impurities at our dedicated R&D Center based at Changodar (Ahmedabad). About us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and affordable medicines across the nation. With more than 4 decades of medical service to society, Unison is today one of the fastest-growing companies in Gujarat State. In addition to this, the company is ranked 82 among the top companies of India (Rupee wise sales) MAT March 2020. This makes Unison a distinguished company across the pharma industry. WE ARE EXPANDING!!! You are invited to join one of fastest growing pharma companies in India!! Department: Analytical development lab Experience: 3 to 6 years Job Role: Analysis of nitrosamine impurities through LCMS Designation: Officer / Sr. Officer Location: Moraiya, Ahmedabad (Transportation is available from specific routes of Ahmedabad) No. of vacancies: 02 Roles and Responsibilities : Method development of nitrosamine impurities/NDSRI/genotoxic impurities on LCMS/MS with proper documentation and prepare Analytical test procedure & worksheet. Routine API & Finished product (Initial & Stability samples) analysis like Nitrosamine impurities, Genotoxic impurities, NDSRI, related substances Method validation for analytical method on LCMS/MS Perks & Benefits Dynamic work environment Career development opportunities Work-life balance Free transportation from specific routes of Ahmedabad Canteen Facility Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharma R&D and possess the required skills, we encourage you to apply for this position. Interested one can share updated resume on career@unisonpharmaceuticals.com to be considered for this role. Apply now to become a part of a growing team!! Regards, Team HR Unison Pharmaceuticals Pvt Ltd
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