Otsuka Hiring for Quality Assurance – Equipment Qualification & Validation Role

Otsuka Pharmaceutical India Pvt. Ltd., a globally recognized name in pharmaceutical innovation and quality manufacturing, is inviting applications for the Quality Assurance – Equipment Qualification & Validation role at its state-of-the-art facility in Moraiya, Ahmedabad. This is an excellent opportunity for skilled and experienced professionals in equipment validation and qualification processes to join a reputed organization known for its high standards in healthcare and pharmaceutical manufacturing.

Position Overview: Quality Assurance – Equipment Qualification & Validation

Designation: Quality Assurance – Equipment Qualification & Validation

Location: Moraiya, Ahmedabad, Gujarat

Experience Required: 5 to 8 years

Educational Qualification: BSc., MSc., B Pharm, M.Pharm

Job Responsibilities:

As part of Otsuka’s Quality Assurance team, the selected candidate will be responsible for ensuring the compliance, validation, and qualification of critical manufacturing and utility equipment. The key responsibilities include:

• Managing equipment validation and qualification activities in adherence to cGMP guidelines.
• Preparing, executing, and reviewing validation protocols and reports for various equipment including Autoclave, Terminal Sterilizer, Mixing Vessel, Tunnel, Washing Machine, and Filling Machine.
• Performing HVAC system qualifications and ensuring all equipment meets regulatory standards.
• Coordinating material issuance for validation activities and updating the Section Manager on activity progress.
• Handling equipment qualification processes such as Steam Heat Sterilizer and Terminal Sterilizer.
• Timely reporting of any deviations or non-conformances to the Section Manager for corrective action.
• Ensuring smooth execution of qualification and validation schedules as per SOPs.

Candidate Profile:

The ideal candidate should possess:

• A results-oriented approach with a keen eye for detail.
• Excellent communication and presentation skills to colla
• borate effectively with cross-functional teams.

Application Process:

Interested and qualified candidates are encouraged to send their updated resumes to:

📧 Anee.Silas@otsukapharma.in