Norbrook Laboratories
Job title:
QA GLP Inspector
Company
Norbrook Laboratories
Job description
Job Description:Job OverviewThe QA GLP Inspector is responsible for conducting inspections and generating audit reports within the R&D GLP Division to ensure compliance with Good Laboratory Practice Guidelines (SI 3106) and OECD GLP standards published as OECD Principles on Good Laboratory Practice (Revised 1997, ENV/MC/CHEM (98)17) and the requirements of Directive 2004/9/EC and 2004/10/EC and associated national legislation. Assist in the upkeep of a current and effective Quality Management System in accordance with Regulatory Authority requirements, company standards and best practices.Main Activities/Tasks
- The main tasks are outlined within the following areas, wherein it is expected that the QA Officer will be pro-active rather than reactive:
- Perform live phase and data inspections of the various GLP sections (Laboratories, Animal facility, test article facility, data analysis, study management, archive facility) for compliance with International GLP Guidelines
- Generate deficiency reports, notify relevant parties including QA and Test Facility Management of inspection findings and recommended actions
- Assist in the upkeep of the GLP Change Control, Deviations, CAPA and Laboratory Investigations databases to contribute to the continued development, performance and compliance of the GLP section and quality of new product development and life cycle management.
- Contribute effectively to the regular, documented Quality review process, that includes a review of Quality performance versus key Quality metrics/KPIs, for all key elements of the PQS including:
- Service Level Agreements with CROs as applicable
- Document Control, Retention and IT Systems
- Review and trending of Deviations and Laboratory Investigations
- Review and tracking of CAPAs
- Clinical Facilities and Study Audit Program
- Change Management
- Conduct of facility audits of the GLP facilities
Essential Criteria:
- Educated to degree level in a relevant life science related discipline or a minimum of two years’ relevant experience working within a GLP or GMP environment. (Full training will be provided).
- Previous laboratory experience, including reviewing data using Empower (CDS).
- Experience in maintenance and trending of deviation and laboratory Investigation systems.
- Experience in managing Change Control.
- Demonstrate the Ability to read and interpret laboratory procedures, methods and data, GLP and regulatory guidance.
- Strong attention to detail.
- Excellent organisation and communication skills (written and verbal) across a range of interdepartmental levels.
- Demonstrate the ability to work independently on assigned responsibilities as well as part of a team to a high standard to meet deadlines.
- A full driving licence is required.
Duration: Full time, permanentLocation: NewryAdditional Information:
Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
We regret that applications received after the closing date and time will not be accepted.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.
Expected salary
Location
Newry
Job date
Wed, 26 Feb 2025 08:31:12 GMT
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