Lead Expert Validation, Dalry

Job title – Lead Expert Validation

Location – Dalry, UK

Job model – On Site

Your key responsibilities

• 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.
• Support and coordinate with corporate validation team.
• 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.
• Support Cleaning, Utilities and Computer System Validation.

We offer

• Empowerment to make meaningful contributions while upholding ethical standards.
• Recognition and celebration of your efforts and accomplishments.
• Being a part of an agile local team at the site.
• Opportunities for growth and advancement for those who embrace innovation and take initiative.
• Opportunity to build a career in a company supplying sustainable products.
• Dedication to creating better futures for customers, communities, people, and the planet.
• Responsibility and accountability in living company values and driving sustainable solutions.
• Supportive environment where individuals are empowered to progress and contribute to meaningful change.

You bring

• Successful candidates should have a degree in a relevant science or engineering discipline.
• Minimum 5 years of validation and qualification experience in a cGMP regulated life science industry, i.e., Pharmaceutical, API or Bio-tech.
• Other essential behaviors are excellent communication and organizational skills, and the ability to work independently & within cross functional teams.

We’re proud to be an equal opportunity employer, and we’re serious about making our hiring process as fair and inclusive as possible. We welcome candidates from all backgrounds — no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we’re here to help.

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