Quality Assurance(QA) Senior Officer (API Pharma)

Job Title: QA Validation Officer / Senior Officer (API Pharma) Department: Quality Assurance (QA) Validation Industry: API Pharmaceutical Manufacturing Experience: 5 to 10 Years Qualification: M.Sc. in Chemistry Location: Chhatrapati Sambhajinagar (Aurangabad), Maharashtra Interested candidate please share your resume to Job Purpose To plan, execute, review, and maintain qualification and validation activities in compliance with cGMP, regulatory guidelines, and company quality standards for API manufacturing facilities. Key Responsibilities - Perform Equipment Qualification (DQ, IQ, OQ, PQ) and Utility Qualification. - Execute Process Validation, Cleaning Validation, and Hold Time Studies. - Prepare, review, and approve Validation Protocols and Reports. - Ensure compliance with cGMP, ICH, USFDA, EU GMP, WHO GMP, and other regulatory requirements. - Review change controls, deviations, CAPA, and risk assessments related to validation. - Coordinate with Production, Engineering, QC, and Maintenance departments for validation activities. - Prepare and maintain Validation Master Plan (VMP) and validation schedules. - Support internal, customer, and regulatory audits. - Ensure timely calibration and qualification of equipment and instruments. - Maintain validation documentation and data integrity in accordance with ALCOA+ principles. Required Skills - Knowledge of Equipment Qualification, Process Validation, Cleaning Validation, CSV (preferred), and Utility Validation. - Sound understanding of cGMP, GDP, Data Integrity, and Regulatory Guidelines. - Good documentation and report-writing skills. - Experience in handling deviations, CAPA, change control, and risk assessment. - Proficiency in MS Office. Preferred Candidate Profile - 5 to 10 years of experience in QA Validation within an API pharmaceutical manufacturing company. - Solid communication and analytical skills. - Ability to work independently and in cross-functional teams. - Experience with USFDA, MHRA, EU GMP, or WHO audits will be an added advantage. .