Otsuka Hiring for Validation Experts / Quality Assurance
Job Title: Quality Assurance – Validation Expert
Company: Otsuka Pharmaceutical India Pvt. Ltd.
Location: Ahmedabad (Moraiya), Gujarat
Experience Required: 5 – 8 years
Qualification: B.Sc, M.Sc, B.Pharm, M.Pharm
Application Mode: Email
Industry: Pharmaceuticals – Quality & Validation
Otsuka Pharmaceutical India Pvt. Ltd. (OPI), a globally reputed pharmaceutical company, is inviting applications from experienced professionals for its Quality Assurance (Validation) team at the Ahmedabad (Moraiya) site. The company is specifically hiring individuals with 5 to 8 years of hands-on experience in equipment qualification and validation activities as per GMP and international regulatory standards. Otsuka Hiring for Validation Experts / Quality Assurance
Job Overview
This role involves the execution and oversight of validation activities associated with pharmaceutical manufacturing equipment and cleanroom systems. The selected candidate will be responsible for protocol writing, implementation, and documentation in compliance with SOPs, GMP, and international guidelines such as those from USFDA and WHO.
Key Responsibilities
The primary duties include: Otsuka Hiring for Validation Experts / Quality Assurance
- Executing and managing validation & qualification activities for the following systems:
- Autoclaves
- Terminal Sterilizers
- Mixing Vessels
- Tunnel and Washing Machines
- Filling Machines
- HVAC Systems
- Reviewing and preparing validation protocols and reports.
- Coordinating material issuance for validation activities.
- Monitoring deviations and reporting non-compliance or discrepancies to the Section Manager.
- Ensuring strict compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and applicable global regulatory requirements.
Desired Profile
Educational Qualification:
- B.Sc. / M.Sc. (Chemistry, Microbiology)
- B.Pharm / M.Pharm
Experience:
- 5 to 8 years of relevant experience in equipment qualification and process validation in a pharmaceutical setup.
Technical Competence:
- Good understanding of sterilization systems, cleanroom HVAC qualifications, and sterile manufacturing protocols.
- Familiarity with regulatory expectations from bodies such as USFDA, WHO, and EU-GMP.
Soft Skills:
- Strong communication and documentation skills.
- Ability to work across cross-functional teams (QA, Engineering, Production).
- Sound decision-making and analytical problem-solving abilities.
About Otsuka Pharmaceutical India
Otsuka Pharmaceutical India Pvt. Ltd. is a part of Otsuka Pharmaceutical Co., Ltd., Japan, a globally renowned company specializing in innovative healthcare solutions. In India, Otsuka operates with a focus on IV fluids, clinical nutrition, and therapeutic drugs. The company emphasizes quality, regulatory compliance, and employee growth, making it a preferred employer in the pharmaceutical industry. Otsuka Hiring for Validation Experts / Quality Assurance
Official Website: www.otsukapharma.in
How to Apply
Interested candidates who meet the eligibility criteria are encouraged to send their updated resume via email: Otsuka Hiring for Validation Experts / Quality Assurance
- Email ID: Anee.Silas@otsukapharma.in
- Subject Line: Application for QA – Validation (Ahmedabad)
Please ensure to include details of your current CTC, expected salary, and notice period in your email.
Why Join Otsuka?
- Work in a company with global recognition and high compliance standards.
- Opportunity to lead validation projects aligned with international regulatory norms.
- Competitive compensation and performance-driven career growth.
- Exposure to high-tech manufacturing processes and cross-functional collaboration.
Important Dates
- Job Posting Date: June 15, 2025
- Application Deadline: Open until position is filled (apply as early as possible)
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