KEY DUTIES AND RESPONSIBILITES:

• Manage end-to-end validation activities related to Clean Utilities and Production equipment at site.

• Well versed with regulations and validation requirements related to Sterile products, Injectables, Ointment, Eye drops, Nasal Spray.

• Participate in projects and evaluate validation requirements in line with Regulatory standards.

• Prepare and review validation documents including, but not limited to installation qualification, operational qualification and performance qualification protocols and reports for Utilities and equipment in manufacturing facility.

• Evaluate Change Control document; perform Risk Assessment to determine criticality of the proposed changes.

• Write, review, and revise validation SOPs compliant with the company policies.

• Provide QA oversight and/or review during the validation process.

• Perform compliance reviews of all applicable Deviations, Investigations, and CAPAs related to qualification and validation.

• Responsible for the validated state of Utilities and Equipment at site.

• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures.

• Identify challenges in validation section and lead the efforts to resolve it.

• Cross train and develop expertise in other areas of validation.

COMPLIANCE AND QUALITY:

• Personnel shall have knowledge and experience of qualification/validation principles and their practical application.

• Ability to pay attention to detail and to work independently, outstanding organizational, interpersonal and analytical skills, and excellent verbal and written communication skills required.

• Must demonstrate multitasking and organizational skills.

• Must be able to interact and lead effectively in a team-based environment.

• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint and Explorer.

• Familiar with regulatory/compliance requirements (PIC/s, EU, US FDA, JP).

EDUCATION & EXPERIENCE:

• Degree a scientific discipline or equivalent.

• Experience in a regulated industry preferred.

• A minimum of 5 years' relevant experience in pharmaceutical manufacturing environment.