Overview
Here at SRG, we are proud to be partnering with this leading European pharmaceutical company on their search for a Validation Specialist to join their team in South Wales.
The core responsibility of the of Validation Specialist is to enhance the Validation practice and compliance; support improvement to validation system; streamline processes. Identify risk areas and required mitigation to meet regulatory inspections e.g. MHRA, FDA, Notified Body etc. through routine compliance activities and specific validation projects.
Key Responsibilities
- Ensure that the Site Validation Master Plan is maintained accurately and Validation Plans are implemented for all relevant aspects of Equipment, Process, Cleaning, Computer Systems, Facilities/Utilities and Analytical Method validation. Maintain and support the updating of Validation Schedules within a team based validation structure.
- Author or review and approve the development and implementation of Validation Master Plans, protocols, reports and standard operating procedures relevant to Validation.
- Technical input into all Validation Lifecycle activities as part of a cross functional team. 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 quality/validation regulations and guidance documents.
- Schedule and coordinate the review of process and equipment validation and re-validation / periodic review in accordance with the established Company validation policy and associated procedures. Complete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements.
- Provide support to the company’s global organisation, as appropriate, relating to validation activities and associated regulatory activities and procedures.
- 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.
- Contribute to and perform related training on site with regards to validation lifecycle and compliance.
As the ideal candidate you will be educated to bachelors/undergraduate Degree in a science or engineering related discipline (chemistry, biology, process engineering, pharmaceutical or medical technology preferred). Alternatively, in house or external training in Validation, Quality and Regulatory activities. You will have at least 1 years experience in validation for the healthcare/pharmaceutical/medical device manufacturing industry.
This job was originally posted as: https://thecareerwallet.com/stats/track/MTUyNzQ5NDE1MS18LTE0NS18LTcw