SKILLS: Validation, Quality, regulatory, GMP, QMS, SAP, MRP, API
TYPE: Permanent
SALARY: £Negotiable – depending on experience
LOCATION: Angus, North East Scotland

The Company

An International Pharmaceutical company is seeking a permanent Validation Co-ordinator to deliver effective and efficient services in the area of quality across the site

The Job

To ensure site activities associated with validation are in compliance with the Companies quality management system requirements and are in compliance with relevant GMP requirements e.g. EU GMP, US GMP, and Japanese GMP. You will deputise for the Quality Assurance Leader as and when directed.  Participate in all aspects of validation activities for the site as directed by the Quality Assurance Leader.  Ensuring effective interaction with Shared Services, including the Validation Shared Service, for the mutual benefit of the company.  Working in line with the department and site requirements, including site KPI’s.

Participate in continuous improvement processes for simplifying validation and manufacturing related processes while also driving improvements in quality and validation effectiveness, as directed by the Quality Assurance Leader.

To participate in visits to the site by FDA, MHRA or other regulatory bodies, audits conducted by Global Quality Assurance and customer quality audits of the site.

To support day-to-day activities associated with maintaining QMS compliance, especially in the area of validation, for the site.  You will proactively manage the validation process to ensure that there is an effective and compliant flow of materials from the site.

Resolving validation challenges and issues that are disrupting the smooth and efficient operation of the Quality Directorate or on site.  Acting as a validation expert for the Quality Directorate and to supply validation quality expertise to support the Quality Directorate team and site on matters of quality.

The Candidate

You will have a relevant degree e.g. chemistry, engineering, have a proven track record in validation along with significant knowledge and experience in quality and compliance, as applied to pharmaceutical API validation and manufacture. 

Knowledge of QMS, Company Systems and Regulatory expectations.  Knowledge of how APIs are manufactured
Specialist knowledge of local products and processes with a more general knowledge of “global” products and processes as well as knowledge of inspections, audits and reviews of operations and processes along with audit experience.

You must work to and understand international API GMP requirements, especially those associated with validation have significant experience in the application of quality/compliance principals within a pharmaceutical environment.  Be able to communicate effectively and work within multi-disciplinary team.

Membership of a professional body e.g. RSC, IOB, CQI, RPSGB, a recognised auditor qualification e.g. IRCA, Regulatory activity awareness, Secondary experience and