Sr. Executive For QC

Job Description Role & Responsibilities: - Perform Analytical Method Validation (AMV) activities, including designing validation protocols, executing validation studies, and documenting results for analytical methods used in raw materials, in-process, and finished product testing. - Participate in method transfer activities from R&D to QC and from QC to production, ensuring completion of all validation steps in line with GMP and regulatory guidelines. - Conduct data analysis and interpretation from validation and verification studies to confirm analytical method accuracy, precision, specificity, and robustness. - Ensure all compliance and documentation meet GMP, GLP, and regulatory standards; maintain accurate records of validation protocols, reports, and outcomes. - Investigate and troubleshoot analytical method or equipment issues encountered during validation or routine analysis. - Maintain regulatory compliance with current FDA, EMA, ICH, and other applicable guidelines related to analytical method validation. - Provide training to QC staff on analytical methods, validation processes, and relevant regulatory requirements. - Participate in instrument qualification and calibration for analytical instruments such as HPLC, GC, UV-VIS, and FTIR. - Support continuous improvement initiatives to enhance method performance, data accuracy, and compliance efficiency. Preferred Candidate Profile: - Education: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. - Experience: Minimum 5 to 7 years of experience in analytical method validation, method development, or analytical testing within the pharmaceutical industry. - Skills: - Proficiency in analytical techniques such as HPLC, GC, UV-VIS, and FTIR. - In-depth knowledge of analytical method validation per ICH Q2(R1) and related regulatory guidelines. - Strong statistical analysis and data interpretation abilities. - Thorough understanding of GMP, GLP, and FDA/EMA regulatory requirements. - Excellent documentation, problem-solving, and communication skills. - Ability to manage multiple validation projects and work effectively under pressure. - Certifications: Certification in Analytical Chemistry or related areas will be an added advantage.