Validation Analyst, Qualification Section

Job Overview

Based within the Validation Department Qualification Section, the successful candidate will be involved in the qualification of pharmaceutical equipment, facilities and utilities including computerised control and monitoring systems across each of the Norbrook sites.

Main Activities/Tasks

• 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

Desirable Criteria:

• 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

Duration: Full Time, Permanent

Location: Newry

Additional Information:

• 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.

Benefits:

• 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

Contact: recruitment@norbrook.co.uk

Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.