Validation Specialist (12 wk contract)

Job Elements: -

• Ensure that the Site Validation Master Plan is maintained accurately and the Validation Plan is implemented for all relevant aspects of Equipment, qualification. Maintain and support update of the Validation Project Schedule.
• Draft and provide Technical input into all Validation Lifecycle activities as part of a cross functional team.
• Compile and implement of Validation Master Plans, protocols, and procedures.
• Provide guidance and support to other internal site departments ensuring compliance with applicable regulatory requirements (MHRA, EU, FDA, U.S., Notified Body and international), International Standards, and validation regulations and guidance documents.
• Serve as subject matter expert and/or team member to support Quality Investigations, CAPA, customer complaint reports, audit findings, failure investigations and continuous improvement opportunities. Ensure accurate and timely resolution and closure to all issues.
• Prepare the final summary validation report for the equipment qualification activities. Review and monitor trends; initiate continuous improvement opportunities, communicate any matters outside the norm to the Validation Section Leader / Site Director of Quality.

The ideal candidate will have:

• Bachelors/Undergraduate Degree in a quality or science related discipline (chemistry, biology, packaging or medical technology preferred). Alternatively, In-house or External training in Validation, Quality and Regulatory activities.
• Previous Validation experience (minimum 5 - 10 years) in Healthcare/Pharmaceutical manufacturing/packing industry.
• Demonstrated expertise in cGMPs, European, FDA regulations, and SOP development.
• Demonstrated understanding of Quality Assurance and Quality Control principles.
• Demonstrated computer skills and a working knowledge of basic computer software (Microsoft Office, Excel, Visio etc. preferred)