QA Specialist (Validation)

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.