Qualification & Validation Industry Specialist
Permanent, Crewe - £50,000 - £60,000
A world leading pharmaceutical manufacturing company who are supporting companies in taking their products from early development through to commercial manufacturing, are looking for a Qualification & Validation Industry Specialist to provide expert support for qualification and validation (Q&V) across site to ensure that processes are implemented to the highest standards of effectiveness and compliance.
Responsibilities
Responsible for the implementation, maintenance and monitoring of validation processes with a specific focus on site engineering and new product introduction projects.
Responsible for authoring, reviewing, supporting, conducting/coordinating qualification and validation activities and other technical studies.
Contribute to the development of new products and processes representing Validation on the project teams. Ensuring the management of validation activities during technology transfers, new product/process introduction and meet the established industry standards for robustness and compliance.
Executing Q&V packages and reporting in a timely manner to maintain compliance, meet project schedules and to ensure minimal disruption to site production planning.
Responding to the most challenging needs as required i.e. leading investigations and recording results, outcomes and mitigations for identified deviations during validation execution. Produce recommendations for action to prevent recurrence. This may also involve acting as investigation leader for site deviations when product quality is impacted.
Advising validation specialists, technologists and engineers on tackling technical issues and challenges relating to the validated state of equipment and processes.
Preparing GMP documentation including change controls, validation protocols & reports, validation master plans, deviations, investigational protocols and reports etc.
Provide technical support for manufacturing, QC laboratories or engineering when expertise is not available within the function.
Requirements
You will be considered a Pharmaceutical Industry Qualification & Validation Expert
Minimum 10 years plus experience of leading and conducting Q&V within the Pharmaceutical industry
Must be able to demonstrate a wide range of experience with successful delivery in the following areas:
- Equipment qualification (both small & large scale production & packing line equipment)
- Facility & Utility Qualification (i.e. building fabric, air, water etc.)
- Process Validation
- Cleaning Development & Validation
Minimum qualification of BSc or BEng
If you think you are a good fit, great! Click 'apply' and we will be in touch shortly to discuss.
