Otsuka Pharmaceutical India Private Limited (OPI), a wholly-owned subsidiary of Japan’s Otsuka Pharmaceutical Factory, is hiring for a Quality Assurance – Equipment Qualification & Validation role at its world-class manufacturing facility in Moraiya, Ahmedabad. Established in 2013, OPI is a leader in intravenous (IV) solutions and clinical nutrition products, exporting to 55+ countries.
Rated 4.1/5 on AmbitionBox for work-life balance (72% rate 4+), OPI offers a supportive culture with six weekends off monthly. Join a global brand committed to “Otsuka-people creating products for better health worldwide”!
About Otsuka Pharmaceutical India Pvt. Ltd.
Headquartered in Ahmedabad, OPI operates a corporate office in Westgate, S.G. Highway, and a USFDA-approved manufacturing plant in Moraiya, 20 km from the city center. With 900+ employees, OPI specializes in parenteral (IV) products and holds certifications from USFDA, PMDA (Japan), and TGA (Australia).
Employees praise the relaxed environment and food facilities (4.0/5 company culture) but note moderate career growth (3.4/5) and low salary increments. Salaries for QA roles range from ₹4–8L/year, with benefits like free transport and meals.
Job Opportunity: Quality Assurance – Equipment Qualification & Validation
- Job Title: Quality Assurance – Equipment Qualification & Validation
- Qualification: B.Sc / M.Sc (Chemistry, Microbiology) / B.Pharm / M.Pharm
- Experience: 5–8 years in QA validation for parenteral manufacturing
- Work Location: Moraiya, Ahmedabad, Gujarat
Responsibilities:
- Validate and qualify equipment, including autoclaves, terminal sterilizers, mixing vessels, tunnels, washing machines, and filling machines
- Perform HVAC system qualifications
- Prepare, review, and execute validation/qualification protocols and reports
- Ensure material issuance for validation activities and compliance with SOPs
- Report deviations to Section Manager and maintain GMP standards
- Support regulatory audits (USFDA, PMDA, TGA)
Required Skills:
- Expertise in equipment qualification (IQ/OQ/PQ) for steam/heat sterilizers, terminal sterilizers, and filling lines
- Proficiency in HVAC validation and cGMP documentation
- Strong analytical, communication, and presentation skills
- Result-oriented with lateral coordination abilities
- Vacancies: Limited (likely 1–2)
- Note: Rotational shifts may apply; male candidates preferred due to shift work. Only parenteral/pharma experience candidates eligible.
Application Details
- How to Apply: Email resume to Anee.Silas@otsukapharma.in with the subject “Application for QA Equipment Qualification & Validation – Moraiya – June 2025.”
- Contact: Not specified; use email for queries
- Website: www.otsukapharma.in
Documents Required:
- Updated resume with passport-sized photograph
- Educational certificates (B.Sc/M.Sc/B.Pharm/M.Pharm)
- Aadhaar Card and PAN Card
- Last 3 months’ payslips and recent increment letter
- Experience certificates or relieving letters
Why Join Otsuka Pharmaceutical India?
OPI offers a platform to work in a USFDA-approved parenteral facility with global exposure. Employees benefit from:
- Work-Life Balance: Rated 4.1/5, with six weekends off monthly
- Learning Opportunities: Exposure to advanced validation and GMP processes
- Benefits: Free transport, meals, and job security (4.0/5)
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Global Reach: Contribute to IV products exported to 55+ countries However, moderate career growth (3.4/5) and low increments are concerns. Some reviews note limited personal development unless well-connected internally. Join a company with a 100-year legacy and a focus on integrity over profitability
Why Moraiya, Ahmedabad?
OPI’s Moraiya facility is located in a pharmaceutical hub, 20 km from Ahmedabad, offering a modern work environment. Accessibility is limited, so personal transport is recommended. Ahmedabad’s vibrant culture and affordable living costs enhance quality of life.
Important Notes
- Eligibility: Only candidates with 5–8 years of parenteral/pharma QA validation experience. Male candidates preferred due to rotational shifts.
- Shifts: Rotational shifts may apply.
- Disclaimer: OPI does not charge fees for job applications. Use only official contact Anee.Silas@otsukapharma.in. Beware of fraudulent offers.
- Note: Candidates interviewed in the last 6 months are not eligible. Expect technical interviews on equipment qualification, HVAC validation, and GMP compliance.
Don’t miss this opportunity to join Otsuka Pharmaceutical India Pvt. Ltd.! Email your resume to Anee.Silas@otsukapharma.in by June 20, 2025, and advance your career in QA validation in Ahmedabad!
