Contract Type: Interim till Nov '18
·Fixed Term until 30th November 2018
·To manage Quality Assurance personnel to maintain, support and improve the Quality Management System, whilst maintaining compliance with regulations and standards for medicinal product and medical devices.
·To manage and perform internal and external audits for commercial products and processes and to review investigations related to product quality complaints.
·To support the QP in the execution of their legal and routine duties, and to maintain key quality documents in line with Global Quality objectives.
·To provide direct line management of Quality Officers and / or Quality Technical Administrators;
·To manage the process, assist and facilitate the identification, assessment, investigation and reporting of quality incidents;
·To provide advice and training on all quality related matters, including GMP, ISO standards, validation, and auditing;
·To review and approve quality related documents for the site, including batch review in support of the certification process;
·To support and facilitate internal and external inspections;
The ideal candidate will have:
·A degree or equivalent in a scientific subject is preferred.
·A minimum of 5 years relevant experience in a Quality environment in the pharmaceutical industry.
·In depth working knowledge of Quality Management Systems, cGMP, regulatory requirements and appropriate ISO standards is essential.
·Project management and project leadership experience, well developed planning skills with ability to meet deadlines.
·Excellent verbal and written communication skills, including the ability to communicate persuasively.
·Able to demonstrate auditing experience, both internal and external.
·Excellent teamwork Ability to work and lead successfully in a matrix organisation.
·Ability to influence and challenge.
Petrie Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers.