Quality Assurance Executive Graduate Jobs in Nashik

Key Responsibilities:Ensure implementation and compliance with cGMP, GLP, GDP, and regulatory guidelines (WHO, USFDA, EU-GMP, Schedule M).Review and approve Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), SOPs, specifications, and protocols.Handle deviations, change controls, OOS/OOT investigations, CAPA, and risk assessments.Monitor in-process quality checks and finished product documentation.Participate in internal, external, and regulatory audits and ensure timely closure of audit observations.Perform and review validation activities including process validation, cleaning validation, and equipment qualification.Control and maintain QA documentation, logs, and quality records.Coordinate with Production, QC, Engineering, and Warehouse teams for quality-related activities.Support product release and market complaint handling.Ensure compliance with data integrity and documentation practices.Required Qualifications:B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry or related discipline)1-5 years of experience in Quality Assurance within a pharmaceutical manufacturing environmentStrong knowledge of GMP documentation and regulatory compliancePreferred Skills & Competencies:Hands-on experience with regulatory audits (WHO / USFDA / MHRA)Knowledge of pharmaceutical quality systems (QMS)Good understanding of validation and qualification proceduresStrong analytical, documentation, and problem-solving skillsProficiency in MS Office and quality management systemsGood communication and coordination abilitiesIndustry:Pharmaceuticals / API / Formulations

Develop and Implement Quality Standards: Create and enforce quality assurance protocols, standards, and procedures to ensure all products or services meet internal and external benchmarks.Conduct Audits and Inspections: Regularly perform audits and inspections on products, processes, and systems to identify defects, deviations, or areas for improvement. This includes raw materials, in-process goods, and final products.Monitor and Analyze Quality Metrics: Track and analyze key quality metrics, such as defect rates, customer complaints, and rework costs. Use this data to identify trends, diagnose root causes of issues, and develop corrective and preventive action plans.Documentation and Reporting: Maintain detailed and accurate quality records, including test plans, inspection reports, and defect tracking logs. Prepare and present reports on quality performance to senior management.Collaboration and Training: Work closely with production, engineering, and supply chain teams to integrate quality standards into daily operations. Provide training and guidance to employees on quality procedures and best practices.Ensure Compliance: Stay up-to-date with relevant industry regulations and certifications (e.g., ISO 9001, GMP) and ensure all processes and products are compliant.