QA GLP Inspector

Our client is a globally recognised pharmaceutical company with a passion for the development & manufacturing of 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 are currently seeking to recruit a Quality Assurance GLP Inspector on a full time, permanent basis – A unique opportunity for you to develop your career within a global organisation.

Roles & responsibilities;

•          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.

•          Conduct of facility audits of the GLP facilities

•          Ensure critical phases, data and reports are audited and findings reported as per in house SOPs

•          Assist in the control/reconciliation of controlled study and facility documents

•          Maintain an awareness of current national and international regulations and requirements for GLP and GCP and other relevant quality related systems and advise on same

•          Auditing of the Pharmacovigilance (PV) facility, external PV distributors, external PV service providers and PV satellite offices

What we are looking for;

•          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.

•          A full driving licence is required.

Desirable Criteria:

•          Experience working in a QA function in a GLP or GMP environment.

•          Experience in the approval, introduction and control of study and facility related documentation.

•          Experience developing and maintenance of Excel spreadsheets for tracking purposes.

•          Understanding of bio-analysis

•          Demonstrable experience in a Clinical setting (in-house and/or CROs etc.,) working on clinical and non-clinical studies operating to GLP

•          Understanding of Good Laboratory Practice principles and standards and quality management systems

•          Knowledge of FDA/EMA practices and guidelines

•          Knowledge of Pharmacovigilance (PV) guidelines and previous experience of conducting PV audits.

•          Experience in the trending and interpretation of analytical data

•          Experience of preparing responses to regulatory queries

If this sounds like an opportunity that could potentially be of interest to you, simply get in touch with Nathaniel Ferris by applying to this advertisement or giving me a call.