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 [email protected]

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.
- Positive 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.

📌 Quality Assurance(QA) Senior Officer (API Pharma)
🏢 Harman Finochem
📍 Sambhajinagar