![Norbrook Laboratories](https://media.trabajo.org/img/noimg.jpg)
Corporate Quality Assurance Site Lead
3 weeks ago
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
**Corporate QA Site Lead**
**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
reviews of operational business units to cGMP and escalate identified excursions from
expectations to senior site operational and quality management.
**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.
**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 cross-functionally
**Essential Criteria**:
form in order to be considered:
- 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**:
Due to the nature of the role preference will be given to applicants demonstrating the
following 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
**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
considered.
**Benefits**:
- Free Life Assurance - On-site free parking
- Company Pension Scheme - Canteen Facilities
- Healthcare cash plan - Employee Perks scheme
- 32 days annual leave - Discounted Car Insurance
- Wedding Leave - Annual Employee raffle
- Company Sick Pay - Employee Recognition scheme
- Employee well-being initiatives - Career development opportunities
- Employee Assistance Programme
**_Norbrook Laboratories Limited employs a workforce with members of all sections of _**
**_the community and is committed to appointing people
-
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