**Job Purpose:** To ensure the quality and compliance of raw materials, packaging components, intermediates, and finished products through rigorous testing, documentation, and adherence to cGMP and USFDA guidelines. **Key Responsibilities:** **1. Analytical Testing & Review** + Perform and review analytical tests on raw materials, intermediates, and finished products using instruments like HPLC, GC, UV, IR, KF, etc. + Conduct stability studies and method validations. + Ensure timely sampling and testing as per pharmacopeial/in-house specifications (IP, BP, USP, Ph. Eur.). **2. Documentation & Data Integrity** + Maintain accurate records in raw data sheets, COAs, logbooks, and LIMS/SAP systems. + Ensure compliance with ALCOA+ principles for data integrity. + Prepare and review SOPs, protocols, and other QC documentation. **3. Regulatory Compliance** + Ensure all QC activities comply with cGMP, GLP, and USFDA requirements. + Support in regulatory audits (USFDA, MHRA, WHO-GMP) and internal inspections. + Review executed batch records and analytical data for regulatory submissions. **4. Instrument Calibration & Maintenance** + Ensure proper calibration and upkeep of laboratory instruments. + Coordinate with external agencies for instrument validation and troubleshooting. **5. Investigations & CAPA** + Participate in OOS/OOT investigations and root cause analysis. + Implement and monitor CAPA effectiveness. **Qualifications:** + **Education:** B.Sc. / M.Sc. / B.Pharma in Chemistry, Pharmaceutical Chemistry, or related field. + **Experience:** 510 years in a pharmaceutical QC laboratory, preferably in a USFDA-approved facility. + **Certifications:** Knowledge of ICH guidelines, cGMP, GLP, and regulatory documentation. **Skills Required:** + Proficiency in analytical techniques and instruments. + Strong understanding of regulatory requirements and documentation. + Experience with LIMS, SAP, and other QC software systems. + Good communication and team collaboration skills. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.