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Senior Scientist
2 weeks ago
Responsibilities
: Develop and validate analytical methods for assay, related substances, dissolution, and stability samples according to GLP and GMP requirements Handle HPLC and GC instruments to perform analysis on various dosage forms, including tablets, ointments, syrups, and injections Maintain and calibrate lab instruments/equipment to ensure accurate and reproducible analytical results Document and interpret analytical data in a timely manner as per GLP/GMP requirements to maintain records and compliance with regulatory norms Provide support to units or CFTs for transfer of analytical methods and techniques to ensure successful and timely transfer of products Maintain proper safety, GLP, and GMP environment in the workplace to minimize accidents and incidentsRequirements:
PhD in Analytical Chemistry or related field 15 to 20 years of experience in Analytical Method Development Laboratory (ADL) Expertise in handling HPLC and GC instruments Knowledge of ICH guidelines and GLP/GMP requirements Experience in method development and validation for assay, related substances, dissolution, and stability samples Excellent documentation and interpretation skills Strong communication and interpersonal skills.Key Skills :
Gc Ich Guideline-
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