Validation Analyst - Qualification section

• Writing and reviewing commissioning, qualification and validation documentation - drafting, reviewing and approving validation related elements of documentation as appropriate including Validation Protocols, Validation Reports, Validation Master Plans and SOPs.
• Co-ordinating and executing commissioning, qualification and validation activities where applicable.
• Being accountable for scheduling, tracking, reporting and achieving project deadlines.
• Providing Input into the core aspects of Operations, Qualification and Validation SOP's.
• Actively contributing to cross-functional project teams.
• Attending Departmental and Team meetings focused on validation activities.
• Serve as a validation representative for internal technical group discussions.
• Understanding and applying industry specific compliance standards/regulations to all Commissioning/Qualification activities.
• Performing planned periodic reviews of equipment and/or systems and ensuring implementation of any remedial actions necessary.
• Essential Criteria:
• Third level qualification in a scientific, information technology or engineering discipline with a strong information technology background. Candidates that demonstrate at least 12 months relevant industry experience and are educated to A-level or equivalent in a science, information technology or engineering related subject will also be considered.
• Good working knowledge of current Good Manufacturing Practices (cGMP).
• Good communication skills; oral and written, e.g., interpersonal and technical report writing skills.
• Good planning and organisational skills with the ability to prioritise and work effectively on multiple tasks.
• Strong data interpretation and problem solving skills

• Knowledge of Pharmaceutical product manufacturing and filling processes.
• Experience in equipment / software / facility qualification in a GMP environment
• Knowledge of Computer System Validation including GAMP5 and 21CFR Part 11 requirements.
• Knowledge of software coding, experience in the implementation of a risk based validation approach, experience with process control & building management systems.
• Experience working on Process / Quality Improvements

• This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy.
• Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
• We regret that applications received after the closing date and time will not be accepted.
• We are unable to sponsor or take over sponsorship of a Visa at this time.

• Free Life Assurance
• Company Pension Scheme
• Healthcare cash plan
• 32 days annual leave
• Wedding Leave
• Company Sick Pay
• Employee well-being initiatives
• Employee Assistance Programme
• On-site free parking
• Canteen Facilities
• Employee Perks scheme
• Employee Recognition scheme
• Career development opportunities

Norbrook Laboratories