Overview
Company: Torbay Pharmaceuticals
About Torbay Pharmaceuticals (TP): TP has a heritage spanning over 50 years with a track record of manufacturing essential medicines. With backing from an investment partner, TP is forging a path in the private sector. TP is a growing and ambitious company that offers opportunities for its people and aims to help save lives.
Position: Validation Manager – Paignton, UK
This is a key role in maintaining product quality, patient safety, and regulatory compliance.
Responsibilities
* Oversee all validation activities related to manufacturing processes, equipment, capital projects, utilities, cleaning, and computer systems to ensure compliance with regulatory requirements (e.g., FDA, EMA, MHRA) and internal quality standards.
* Develop, implement, and manage validation master plans (VMPs) for equipment, processes, cleaning, and computer systems.
* Lead the creation, execution, and review of validation protocols (IQ/OQ/PQ) and reports, in conjunction with site SMEs.
* Lead validation efforts for sterile processing, cleanroom qualification, and sterilisation validation (e.g., autoclaves, SIP, CIP).
* Oversee environmental monitoring validation and critical utility validation (e.g., WFI, compressed air, HVAC).
* Ensure validation activities comply with GxP, FDA, EMA, and MHRA regulations.
* Manage risk assessments and change controls related to validated systems.
* Collaborate with cross-functional teams including QA, Engineering, Manufacturing, Product Development, Quality Control and IT.
* Support internal and external audits and inspections by regulatory authorities.
* Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices.
* Train and mentor validation staff and ensure continuous improvement of validation processes.
Requirements
* Bachelor’s or Master’s degree in Life Sciences, Engineering, Pharmacy, or a related field.
* Experience in pharmaceutical validation or quality assurance.
* Strong knowledge of validation principles, GxP, and regulatory guidelines (FDA, ICH, EU GMP).
* Experience with computer system validation (CSV) and process validation.
* Proficiency in validation documentation and electronic quality systems.
* Excellent analytical, organizational, and communication skills.
* Experience leading a team.
What we offer
We offer roles and career opportunities on your doorstep with defined career pathways and the chance to move between roles and departments. TP supports your career journey. International expansion means growth and new opportunities.
Benefits include 27 days holiday plus Bank Holidays, group life assurance, pension, medical, and more.
Please note: applications will not be reviewed until week commencing 26th August.
Application and Data
There is a CV upload option: Click to upload a file (doc, docx, txt, rtf, pdf, odt; max 2 MB).
Privacy: Torbay Pharmaceuticals is committed to transparency about data collection and use for processing applications and future opportunities. We will add you to our talent pool for 12 months unless you opt out. For removal, email tpapplications@torbaypharma.com. See our Privacy Policy for details on data protection and rights.
I declare that I have read and understood the information.
#J-18808-Ljbffr