Quality Control Officer

3 days ago

Karad MH IN BRIX BIOPHARMA Full time

Senior Quality Control Officer is responsible for overseeing and performing quality control activities to ensure that all raw materials in-process samples and finished pharmaceutical products meet the required quality standards and regulatory specifications The role involves analytical testing documentation instrument calibration and compliance with Good Laboratory Practices GLP and Good Manufacturing Practices GMP Key Responsibilities Conduct analysis of raw materials in-process and finished products using approved test methods and specifications Review and verify analytical data results and laboratory records for accuracy and compliance Supervise junior QC analysts and provide technical support and training as required Ensure timely calibration maintenance and qualification of laboratory instruments e g HPLC GC UV FTIR Dissolution tester Prepare and review Standard Operating Procedures SOPs test reports and analytical method validation documents Participate in method validation stability studies and process validation activities Ensure adherence to GLP GMP and regulatory standards WHO USFDA MHRA EU-GMP etc Handle deviations out-of-specification OOS and out-of-trend OOT results in coordination with QA and Production teams Maintain good documentation practices and ensure data integrity Support internal and external audits and implement corrective and preventive actions CAPA Coordinate with cross-functional teams to resolve quality issues and improve laboratory performance Qualifications Skills Education M Sc Chemistry Analytical Chemistry or B Pharm M Pharm Experience 6-15 years of experience in pharmaceutical QC formulation bulk drug sterile manufacturing environment preferred Technical Skills Hands-on experience with analytical instruments HPLC GC UV FTIR etc Knowledge of analytical method validation stability testing and impurity profiling Familiarity with pharmacopoeias USP BP IP EP Understanding of cGMP GLP and data integrity requirements Soft Skills Strong analytical and problem-solving abilities Excellent communication and leadership skills Good documentation and organizational skills Ability to work under minimal supervision and manage multiple tasks efficiently Key Performance Indicators KPIs Accuracy and reliability of analytical results Compliance with GMP GLP and documentation standards Timely completion of testing and release activities Reduction in lab errors OOS OOT incidents Successful audit performance and regulatory compliance Job Type Full-time Pay 15 000 00 - 25 000 00 per year Benefits Paid sick time Paid time off Provident Fund Work Location In person

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