AddressBrightwork are currently recruiting for a Validation Specialist to join our client, a renowned manufacturer in their site in Ayrshire during an exciting period of expansion and growth.
The Validation Specialist responsibilities include:
- Leadership role within the Quality Department responsible for the management and co-ordination of the site cGMP validation activities.
- Support validation activity during design, installation & commissioning of new equipment, processes, packaging lines & facilities and utilities.
- Ensure the validated status of site facilities, i.e., equipment, processes, CSV and utilities is complete and compliant with internal local and corporate procedures, relevant regulatory requirements and industry guidance.
- Authoring, reviewing, executing and maintaining validation documentation including site Validation Master Plan and Site Validation Strategy.
- Support Production departments in validation activities for processes and equipment.
- Preparation and management of validation plans, protocols and reports.
- Supporting external audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors.
- Execute validation protocols and drive to completion any CAPA associated with non-conformances raised.
- Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed.
- Ensure product quality through robust testing and process monitoring including the use of statistical techniques.
Successful candidates should have a degree in a relevant science or engineering discipline along with validation and qualification experience in a cGMP regulated life science industry, i.e., Pharmaceutical, API or Bio-tech. Other essential behaviours are excellent communication and organisational skills, and the ability to work independently & within cross functional teams.
Brightwork is a recruitment agency for those seeking permanent work and a recruitment business for those seeking temporary work.
