Senior Validation Specialist
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We have an exciting opportunity for a Senior Validation Specialist to join our team based in Hove. The purpose of the role is to provide leadership for and management of validation projects, review, develop and improve current Custom Pharma Services validations, ensure all processes, equipment, utilities, and facilities are validated, provide assurance that all validation activities are performed in compliance with company quality objectives, GMP and applicable statutory and regulatory requirements and to ensure we have a good validation inspection readiness status with validation projects described in the site Validation Master Plan (VMP) completed.
Please note: Applicants must have the right to work in the UK without requiring sponsorship, we do not hold a sponsorship licence.
About Custom Pharma Services (CPS)
Custom Pharma Services is located in Brighton, UK since 1979 and is a full-service contract development and manufacturing organisation (CDMO) providing services tailored to your needs, no matter how niche or complex. Custom covers the full spectrum of activities from development through commercial manufacturing for both clinical and commercial use. Specialising in Oral Solid Dosage forms with the ability to handle highly potent drugs and poorly bioavailable compounds Custom really is your one stop resource. With direct access to highly skilled experts offering a partnership approach Custom Pharma Services truly has a molecule first mentality, managing all projects with the end in mind. Custom Can!
Custom Pharma Services is an Investors in People Silver accredited workplace where teamwork and support is encouraged, and where every individual is valued and supported to achieve their full potential because if you can, then Custom Can!
What you will be doing;
• Effectively leading the execution of validation projects.
• Providing commissioning, qualification, and validation support to new and ongoing projects across the site.
• Ensuring validation and revalidation requirements are identified and implemented.
• Confirming that all required processes and / or equipment remain in a validated state in accordance with company policy and regulatory requirements.
• Composing, reviewing and approving all validation documentation associated with processes, equipment and utilities / facilities.
• Ensuring the maintenance of the site validation system in an 'inspection ready' status.
• Contributing to the development and training of validation team members. This will be in capital projects management and specialist areas of validation, for example cleaning validation, CSV, equipment qualification, and facility and utility qualification.
We are looking for candidates who have;
• Degree level qualifications in an Engineering / Science discipline or equivalent, or;
• Lower-level qualification in addition to validation experience
• A project management qualification is desirable but not essential
• Previous experience within a quality (validation) environment in the pharmaceutical industry
• Proven track record of successful projects management
• Specialist areas such as CSV (Computer Systems Validation) and cleaning validation
• A thorough understanding of Good Manufacturing Practice
• Strong teamwork skills
• Familiarity with the application of Risk Management
• Good leadership and communication skills
• Good planning and organisational skills
• Good computer skills (Competent in Microsoft Word and Excel)
• Strong documentation skills and systems compliance experience is necessary (follow written procedures with accuracy and efficiency)
• Attention to detail
• Ability to prioritise workload
• Work under minimum supervision
• Literate and numerate
• Good problem solving skills
Our benefits package includes:
• Rising holiday allowance to 26 days holiday plus UK bank holidays
• Group personal pension scheme
• Annual profit related company and individual bonus payment based on successful performance
• Life assurance at twice annual salary
• Health Plan with Simply Health including access to a GP or Counselling Services 24/7, money back on prescriptions, optical, dental and physiotherapy
• Ride to work scheme
• Subsidised Gym Membership
• Discount Shopping Portal
• Enhanced Maternity / Paternity Pay
• Employee Referral Scheme bonus of £1,000
• Values based awards
Successful candidates will be required to complete a basic disclosure check.
Strictly no agencies please.