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 atull@harmanfinochem.com

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.
• Strong 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.