
Senior Officer
3 days ago
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. 2–5 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 integritySoft Skills:
Excellent communication and documentation skills Ability to work independently and in a team Problem-solving and critical thinking abilities-
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