Validation Consultant

We are looking for an experienced Validation Consultant to support our client in the build out of their new manufacturing facility. We are looking for an individual with Radiopharma or sterile injectable experience. Overview and description below. Local candidates only.

Duties: Validation of facility, analytical methods, computer methods, and personnel; Protocols are currently being written so taking those from departments and validating them; Immediate tech transfer validation

• 100% onsite
• Likely to last through the end of 2024
• 40hrs per week

The Validation Consultant is responsible for the development and implementation of the strategies for the qualification of the production facilities and equipment including compliance with 21 CFR 210/211, current FDA Guidance industry standards.

RESPONSIBILITIES

• Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.
• Close liaison with the building contractors, engineers and vendors of facility and equipment items to ensure full and appropriate information is provided, along with vendor qualification protocols.
• Support FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.
• Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities once production has commenced.
• Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation.
• Provides alternatives to validation if outsourcing is an option.
• Establish and monitor Key Performance Indicators (KPIs) so that performance and budget are maintained.
• Reports KPIs on a periodic basis and provides updates to the Quality Management Review committee.