Senior Validation Specialist-Innovative Company-UK

My client is a renowned manufacturer that is looking for an experienced Senior Validation Specialists to come on board as soon as possible to take part in a variety of projects within the pharmaceutical sector.

This will be an opportunity to come in to a job where you will be engaged from the start to the finish with very innovative drugs. Such a varied portfolio will allow for an interesting work environment!

The company is a stable, rapidly expanding UK Based company, listed on the London Stock exchange! Even though the company operates worldwide, they are still expanding, and they are looking for an experienced leader to be part of the experience!

Responsibilities

• Provide the leadership for the core validation processes in parallel with other stream leads to ensure effective management of the Quality System. Ensure that departmental objectives are implemented in line with the overall Quality /Corporate goals.
• The key quality processes to be led but not limited to be equipment, utilities, facilities, cleaning, transport, packaging and IT validation.
• Review and approve internal and supplier system lifecycle documentation relating to validation (e.g. user requirement specifications, functional specification, installation qualification, operational qualification etc.).
• Assist in ensuring departmental understanding and compliance with the requirements of cGMP and validation as applied to the Wales site and range of products. Maintain a working knowledge of European and US GMP guidelines and industry guidance (ISPE GAMP publications).
• Ensure effective coordination and QA leadership (as per stream lead) for the Wales Site Validation Master Plan, timely planning of activities, managing contractor activities and timely execution and reporting of validation activities in adherence with the SVMP.
• Conduct review of Change Control Requests, ensuring compliance with cGMP and validation requirements. Assist in the development of change control action plans and impact assessments. Follow up on recommended actions.
• Prepare and present quality reports, data and Key Performance Indicators regarding validation activities to management for review at quality review meetings.
• Participate in the development and maintenance of the Company's Quality System to meet the requirements of the relevant regulatory authorities, Notified Bodies (if applicable) and ISO standards (as applicable) and all other applicable quality and regulatory standards.
• Training of employees in Validation procedures and principles.
• Carry out other reasonable tasks as required by the Line Manager.

Candidate Profile

• Degree in appropriate science discipline (chemistry, biology or medical technology preferred).
• 5+ years of experience in a drug manufacturing, medical device or biologics industry in Quality Assurance, Quality Control or Quality Engineering position.
• Previous leadership experience.
• Experience of front line involvement with Regulatory Inspections.
• Strong technical background, gained from a highly regulated environment: pharmaceutical, biotechnology or related industry, including exposure to the regulatory requirements affecting validation
• Demonstrated knowledge of cGMPs, MHRA, FDA regulations and SOPs.

Deadline 30th May.

If you feel that you fill the required criteria, get in touch with me at:

Arnaud Schmitt Fillaire

Tel: +44 207 940 2105

Email: a.schmitt-fillaire@nonstop-pharma.ch