Corporate Quality Assurance Site Lead - Newry, United Kingdom - Norbrook Laboratories
Description
In Norbrook we pride ourselves in being one of the top companies in Northern Ireland and one ofthe 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
- Participate as part of a cross functional team
- Good planning and organisational skills with the ability to prioritise and work effectively on
- 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
leadership (quality and operational) for further action.
- Ensure that plans are provided by the operational business unit owners to address all
- Check effectiveness of corrective plans.
- Perform internal quality audits as assigned by Internal Audit management. To participate in
- Identify key performance indicators for site operational quality performance and
- Supply regular reports of KPI statistics and observations to the Senior Management.
- Manage any assigned market actions associated with the operational business units and
basis to meet the expected timeframes.
- Reviewing and where appropriate approving or authorizing SOPs or other GMP documents
- 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
Essential Criteria:
- Minimum five years' experience in a quality auditing or operations quality assurance role in
- Third level qualification (a scientific or engineering discipline
would be preferred but not
***- 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
***- 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
- Experience of leading or participating in Quality Management System audits
- Experience of field market actions such as product defect reporting, batch/product recall
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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