Quality Systems Manager

Job Description

Pets Choice Ltd TA Bob Martin manufactures veterinary medicines, biocides and many other companion animal healthcare and hygiene products at its factories in Yatton, Cardiff and Blackburn. Reporting to the Technical Director the Quality Systems Manager will be responsible for ensuring that all products comply and/or exceed all regulatory requirements and meet all customer and consumer expectations of quality through the products usage and appearance whetherit is branded or private label.Primary Responsibilities

• Responsible for the design and implementation of Quality Management Systems based on GMP, GLP, GDP and BRC that creates an ethos of quality across all sites which supports manufacturing excellence.
• Maintain a Quality Management System that ensures compliance with a Medicines Manufacturing license (ManA) for the Yatton site and BRC for Cardiff.
• Manage a Quality Systems team who create the quality framework and who then work with Operations colleagues to implement the system and to resolve any issues to refine and improve the systems effectiveness.
• Liaise with third party suppliers to ensure that we have all necessary Quality contracts in place to meet contractual requirements for the distribution of medicines and compliance on pharmacovigilance.
• Responsible for managing the internal audit schedule and assign trained auditors to perform the audits.
• Responsible for managing the suppliers audit schedule and assign trained auditors to perform the audits.
• Maintaining QMS documentation, focusing on Policies, SOP`s, Work Instructions, Test Methods, etc. Manage the review and approval cycle of all controlled documents.
• Help in the general standardisation of processes, focusing on process mapping and simplifying existing documentation.
• To assist in the interpretation of regulatory requirements and to help all departments to mirror them into their associated Policies, SOP`s, Work Instructions and Test Methods which will all form the Document System that defines all business activities.
• Responsible for managing the training program and training records of the Quality Department staff.
• Organise and lead on customer related audits.
• Liaise with inspection bodies and lead and organise external audits.
• Responsible for managing corrective action plans resulting from deviations found during internal and external audits (inspection bodies and customers)
• Provide technical support to the Companys Consumer Care function as and when required, e.g. analysing and commenting on returned samples in consumer complaints.
• Overall responsible for the review and implementation of procedures within the company.

Requirements

• Excellent written and verbal communication skills are required by the job holder as in the course of the duties.
• Flexibility and the capability of working alone with minimal supervision would be a key quality of the ideal candidate.
• Good understanding of GMP regulations in the context of pharmaceuticals and Quality Assurance activities, especially relating to GMP documentation and controlled document.
• Experience with Validation activities would be a considerate advantage.
• Knowledge of GxP guidelines and regulations such as GMP and GDP.
• This is a broad, challenging role that requires meticulous attention to detail, strong communication skills and the ability to multitask.
• We are inviting candidates with a strong QA & scientific / technical / engineering background (ideally a degree), and work experience gained in a GMP environment.
• Knowledge of QA processes and systems, combined with experience of SOP creation and improvement, would be a strong advantage.

Based: Yatton, SomersetFull time, Permanent

Keyskills :
Control SystemsDocument ManagementQuality AssuranceQuality ControlRegulatory Requirements