SKILLS:  Quality, Certificate for Overseas manufacture (CoOm), Regulatory, API, QMS, Pharmaceutical, GMP
TYPE: Permanent
SALARY:  £neg  - depending on experience
LOCATION: Angus, North East Scotland,

The Company

An International pharmaceutical company is seeking a permanent Compliance Officer to join their team to deliver effective and efficient services in the area of Quality to the site in a lean and effective way.

The Job

You will ensure that the day to day and routine compliance challenges are resolved in an effective and timely manner.  You will also deputise for the Quality Compliance Leader as directed.  Participate in all aspects compliance activities for the site as directed by the Quality Compliance Leader.  To ensure effective interaction with Shared Services for the mutual benefit of the company.  Working in line with department and site requirements, including site KPI’s, participating in continuous improvement processes for simplifying compliance related processes while also driving improvements in effectiveness, as directed by the Quality Compliance Leader.  To participate in a compliant, lean and effective site audit process that maximizes ‘value add’ to the site.  Managing day to day activities associated with maintaining QMS compliance across the site.  Participating in site visits by FDA, MHRA or other regulatory bodies.  Resolving compliance issues that are disrupting the smooth and efficient operation of the Quality Directorate or the site.

The Candidate

You will hold a relevant degree e.g. chemistry, have significant knowledge and experience in quality and compliance, as applied to pharmaceutical API manufacture along with knowledge of QMS, company systems and regulatory expectations. Specialist knowledge of products and processes, with a more general knowledge of “global” products and processes Knowledge of inspections, audits and reviews of operations and processes and audit experience is desirable. Membership of a professional body e.g. RSC and Recognised auditor qualification e.g. IRCA Regulatory activity awareness would be advantageous.