Validation Analyst – Qualification section

Location UK / Ulster

Job Type Permanent full-time, TemporaryContract

Salary Not disclosed

Updated 6 days ago

Reference 1392381

 Job Description

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.

In Norbrook we pride ourselves in being one of the top 11 companies in Northern Ireland and in the top 15 veterinary pharmaceutical companies globally. We develop & manufacture veterinary medicines, supplying products to 120 countries globally. With a strong portfolio of existing products and significant investment in R&D to launch new products annually, we have opportunities for individuals to join us and develop their career in a global company.

Our business strategy is supported by our Values – Customer Value, One Team, Results Driven, Excellence, Innovation, and Quality – and we support our employees to live the behaviours that creates our culture.  Our on-going success is based on the expertise, knowledge and innovation of our employees. If you are interested in joining our team here at Norbrook and supporting our vision, then apply for this role.

 

Job Overview / Main Activities/Tasks

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.  The role will include but not be limited to:

  • 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.

 

Key Skills:

  • 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

 

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).

 

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, Co. Down

Remuneration: Salary Attractive

Benefits: Free Life Assurance, Paid Holidays, On-site Parking, Pension Scheme, Canteen Facilities, Healthcare plan, Childcare Vouchers, Discounted Car Insurance, Perks Scheme

Contact: The Human Resources Department

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.