Senior Officer

2 days ago

Daman Nagar Diu India SUN PHARMA Full time

Job Description Job Summary The QC Analyst is responsible for performing analytical testing of raw materials, in-process samples, and finished pharmaceutical products to ensure compliance with USFDA regulations, cGMP standards, and internal specifications. This role is critical in maintaining product quality, safety, and efficacy. Key Responsibilities - Analytical Testing: - Conduct chemical, physical, and microbiological tests using techniques such as HPLC, GC, UV-Vis, FTIR, titration, and dissolution. - Perform stability studies and method validation as per regulatory guidelines. - Documentation & Compliance: - Maintain accurate and complete records of all testing activities in compliance with GDP. - Document and investigate any Out-of-Specification (OOS) results. - Ensure adherence to cGMP, GLP, and USFDA regulations. - Equipment Handling: - Calibrate, maintain, and troubleshoot laboratory instruments. - Ensure proper usage and upkeep of analytical equipment. - Cross-Functional Collaboration: - Coordinate with Production, QA, and R&D teams to resolve quality issues. - Participate in internal and external audits. - Continuous Improvement: - Assist in developing and validating new analytical methods. - Recommend improvements to testing procedures and quality systems. Qualifications: - Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or related field. - 25 years of experience in a pharmaceutical QC laboratory, preferably in a USFDA-approved facility. - Hands-on experience with analytical instruments and techniques. - Knowledge of regulatory guidelines (USFDA, ICH, WHO). - Strong attention to detail and analytical skills. Preferred Certifications: - Certified Quality Analyst (CQA) - Training in cGMP, GLP, and data integrity Soft Skills: - Excellent communication and documentation skills - Ability to work independently and in a team - Problem-solving and critical thinking abilities

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