QA/QC Executive / Senior Executive Mana Pharma

Job highlights

• Review batch manufacturing and packaging records (BMR / BPR)
• Proficient in analytical instrumentation and documentation practices
• We are looking for a skilled and proactive QA / QC professional with 2 5 years of experience to join our quality team
• 2 5 years of hands-on experience in analytical techniques and instruments in a regulated environment

? Job Description: ?

? We are looking for a skilled and proactive QA/QC professional with 2 5 years of experience to join our quality team. The candidate will be responsible for executing and overseeing quality assurance and quality control activities in compliance with regulatory and company standards. ?

? Key Responsibilities: ?

? Quality Control?

• ? Perform analytical testing of raw materials, in-process samples, and finished products. ?
• ? Operate, calibrate, and troubleshoot instruments such as HPLC, UV-Vis, GC, FTIR, and KF. ?
• ? Prepare and review analytical documentation including test reports, COAs, and calibration records. ?
• ? Guide and Mentor QC Executives / Trainees for analytical testing

? Quality Assurance?

• ? Review batch manufacturing and packaging records (BMR/BPR). ?
• ? Investigate and document deviations, OOS, OOT, and implement CAPA with timely closure. ?
• ? Review and manage controlled documents (SOPs, protocols, forms) issuance, retrieval, and archival. ?
• ? Perform internal audits; support regulatory audits (e. g. , WHO, ISO, etc. ). ?
• ? Oversee GMP, GLP, hygiene training for production and QA/QC staff. ?
• ? Coordinate stability studies, analyze trends, and maintain stability protocols and logs. ?
• ? Ensure data integrity in documentation and electronic systems. ?
• ? Participate in risk assessment and mitigation for quality events. ?
• ? Support technology transfer, scale-up, and cross-functional quality activities. ?
• ? Evaluate and audit vendors and suppliers as part of QA oversight. ?

? Requirements: ?

• ? 2 5 years of hands-on experience in analytical techniques and instruments in a regulated environment. ?
• ? Strong understanding of cGMP, GLP, and ICH regulatory requirements. ?
• ? Proficient in analytical instrumentation and documentation practices. ?
• ? Ability to handle audits, deviations, and quality systems independently. ?
• ? Excellent communication, collaboration and organizational skills. ?
• ? Team player with attention to detail and accuracy. ?