Corporate Quality Assurance Site Lead - Newry, United Kingdom - Norbrook Laboratories

Norbrook Laboratories

Verified Company

Newry, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 crossfunctionally

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 nonsterile 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: