Corporate Quality Assurance Site Lead

1 week ago

Newry, United Kingdom Norbrook Laboratories Full time
In Norbrook we pride ourselves in being one of the top companies in Northern Ireland and one of

the top 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,

Job Overview
We are currently recruiting for a Corporate Quality Assurance Site Lead within our Corporate QA
department. The purpose of the role is to set and monitor Key Performance Indicators for quality at
units to cGMP and escalate identified excursions from expectations to senior site operational and
quality management.

Key Skills

  • Excellent knowledge of EU and US GMP
  • Good communication skills; oral and written, e.g., interpersonal and technical report writing
skills.

  • Participate as part of a cross functional team
  • Good planning and organisational skills with the ability to prioritise and work effectively on
multiple tasks.

  • Strong data interpretation and problem solving skills.
  • Ability to lead projects where members are drawn crossfunctionally

Main Activities/Tasks

  • Based on a rotational basis at individual operational business units, monitor quality
performance of the operational units to cGMP and escalate identified issues to site
leadership (quality and operational) for further action.

  • Ensure that plans are provided by the operational business unit owners to address all
identified discrepancies from expected quality performance.

  • Check effectiveness of corrective plans.
  • Perform internal quality audits as assigned by Internal Audit management. To participate in
- manufacturer, supplier and sub-contractor audits as required.
  • Identify key performance indicators for site operational quality performance and
- communicate these and monitor and report on the KPIs.
  • Supply regular reports of KPI statistics and observations to the Senior Management.
  • Manage any assigned market actions associated with the operational business units and
ensure that site operational business unit leadership provide reports and CAPAs on a timely
basis to meet the expected timeframes.

  • Reviewing and where appropriate approving or authorizing SOPs or other GMP documents
where appropriate.

  • To participate in customer and competent authority audits of Norbrook as required.
  • To undertake any ad hoc duties as required to sustain improvement and compliance of the
quality system in Norbrook Laboratories Ltd.

Essential Criteria:

  • Minimum five years' experience in a quality auditing or operations quality assurance role in
the pharmaceutical industry.

  • Third level qualification (a scientific or engineering discipline
    would be preferred but not
essential)
***- Excellent working knowledge of current Good Manufacturing Practices (cGMP) for both EU

and US
**
Desirable Criteria:
  • Knowledge of sterile and non
  • sterile pharmaceutical product manufacturing, filling
processes and analytical processes.
***- Knowledge of validation activities/methodologies

  • Experience leading a Quality Assurance function in an operational/production environment
  • Experience identifying and investigation of excursions from GMP and the implementation of
corrective actions

  • Experience of leading or participating in Quality Management System audits
  • Experience of field market actions such as product defect reporting, batch/product recall
activities

Location:
Newry, Co. Down

Remuneration:
Salary Attractive

Benefits:
Free Life Assurance, Company Pension Scheme, 31 days annual leave, Wedding Leave,
Employee well-being initiatives, Healthcare plan, Company Sick Pay, Employee Assistance
Programme, On-site free parking, Canteen Facilities, Employee Perks scheme, Discounted Car
Insurance, Annual Employee raffle, employee recognition scheme, career development
opportunities and much more

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._

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