KEY DUTIES AND RESPONSIBILITES:
• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.
• Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility.
• Candidate must have knowledge and experience of qualification/validation principles and their practical application.
• Preparation and review of process and cleaning validation protocols and reports.
• Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.
• Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes.
• Write, review, and revise validation SOPs in compliance with regulatory guidelines.
• QA oversight and/or review during the validation process.
• Manage incidents and deviations related to validation & qualification.
• Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.
• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.
• Cross train and develop expertise in other areas of validation.
• Must be able to interact and lead effectively in a team-based environment.
• Familiarity with regulatory/compliance environment.
EDUCATION & EXPERIENCE
• Degree a scientific discipline or equivalent.
• Experience in a regulated industry preferred.
• A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.
• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.
