Job
Description
Job Title: Quality Assurance (QA) Executive / Officer Location: Tamil Nadu, Kerala, Andhra Pradesh, Karnataka. Department: Quality Assurance Job Type: Full-time Industry: Pharmaceutical / Chemicals / Life Sciences Job Summary: We are seeking a detail-oriented and experienced Quality Assurance (QA) professional to ensure that our processes comply with Manufacturing QA , regulatory standards , and internal quality procedures. The ideal candidate will be responsible for monitoring, documenting, and improving product quality from raw materials to finished goods. Key Responsibilities: Monitor and enforce compliance with Manufacturing QA and Standard Operating Procedures (SOPs) Conduct internal audits and support external inspections (e.g., FDA, WHO, ISO, CDSCO) Review and approve Batch Manufacturing Records (BMRs) , Batch Packaging Records (BPRs) , and change controls Investigate deviations, non-conformances, OOS (Out of Specification) and prepare CAPA (Corrective and Preventive Actions) Participate in qualification and validation processes (e.g., process, cleaning, equipment) Manage document control systems for SOPs, specifications, protocols, and logs Coordinate with production, R&D, QC, and warehouse departments to ensure product quality Ensure regulatory compliance for raw materials, intermediates, and final products Maintain up-to-date knowledge of local and international quality regulations Qualifications: Bachelors or Masters degree in Pharmacy, Chemistry, Biotechnology, or related science field Strong experience in QA in pharmaceutical, chemical, or life sciences industry Knowledge of cGMP, ICH guidelines, regulatory audits, and quality systems Proficient in documentation, audit handling, and CAPA systems Experience with validation, risk assessment, and quality tools (e.g., RCA, FMEA) Preferred Skills: Familiarity with ERP/LIMS/QMS software Strong analytical and problem-solving skills Effective communication and coordination abilities Attention to detail and a strong sense of accountability Prior experience with regulatory audits (e.g., USFDA, WHO-GMP, MHRA) is a plus
