Quality Systems Auditor Job in Merseyside, North West Uk

A Quality Systems Auditor is required for a global pharmaceutical company who manufacture human and animal healthcare products which enhance wellness and performance.

Due to continued growth, the now require a quality systems auditor to carry out audits of the Site, Material Suppliers and GMP Service Providers to ensure that they comply with the appropriate quality requirements / regulations e.g. cGMP, Corporate Standards, ISO 9001, FDA, MHRA and FAMI QS.

Key Responsibilities:
• Carry out site self-assessments.
• Carry out external supplier audits on behalf of the company and Global network.
• Ensure Site performs effective quality management reviews which include:
• Develop and implement Quality Lead Team schedule. Facilitate monthly QLT.
• Develop Annual Global Quality system reviews
• MSOC reporting metrics
• Responsibility for Compliance reports (Site and Contract Manufacturers).
• Manage site and Team Quality Plans.
• Co-ordinate Global and external Regulatory ISO audits of the Site.
• Perform gap assessments against changes to Global Quality Standards.
• Develop and manage quality projects for the Site and the Quality Unit.

A thorough knowledge and understanding cGMP and the ability to apply the requirements of cGMP (as defined by the Regulatory agencies and Global Quality Standards) to processes and procedures is essential as well as several years' experience in a Quality or technical role or previous audit experience.

Essential skills:
• Must have strong influencing, leadership and interpersonal skills.
• Proven ability to manage a variety of conflicting demands to meet clearly defined goals.
• Good oral and written communication skill
• Ability to interact effectively at all levels of the organisation both internally and externally; and with Suppliers, Contract Manufacturers and Regulatory Inspectors.

Desirable Skills:
• Good basic computer skills, using Word, Excel. Powerpoint.
• Global systems e.g. Trackwise, Regulus, SAP
• Effective presentation skills