The role involves responsibility for relevant sections of the Quality Management System (QMS) to implement and execute tasks relating to day-to-day Quality Assurance (QA) aspects, but also executing those tasks him/herself. The role entails taking responsibility for QA matters around processes and documentation and for the QA team under their responsibility and supervision.

Responsibility:

Oversight of assigned Quality Management System areas that would also include but not be limited to:

• Lead, support, develop and mentor QA team members under their direct supervision.
• Leads development and maintenance of QMS documents and eDMS.
• Leads in the execution of training for quality & other relevant personnel.
• Implementation of the defined quality objectives for their QMS areas.
• Control and further development of the QMS areas under their oversight.
• Distribution, structuring and monitoring of quality tasks associated to QMS areas.
• Assist in the execution of tasks related to the daily aspects of QA department and QMS.
• Participation in customer meetings to discuss metrics or QMS aspects.
• Coordinates and assists with internal GMP audits.
• Assists in the performance of external audits (e.g vendors, as required).
• Supports and assists with customer and regulatory audits and actions as required.
• Hosts/attends cross-departmental meetings as required acting as the quality representative.
• Supports relevant aspects of the QMS associated with management of changes, investigations, deviations, root cause analysis, CAPAs, risk assessments, qualification/validation, recalls and quality metrics as required by the business.
• Undertakes and supports quality related tasks associated with strategic projects.

Requirements:

• 5 Years’ Experience within a quality systems related role (ideally pharma related) required.
• 2 to 3 years experience of leading teams/people with experience in disciplinary processes required.
• Demonstrable experience within Quality department, ideally in a packaging or pharmaceutical company or comparable required.
• EU GMP framework knowledge required.
• Knowledge of packaging equipment, facilities and processes preferred.
• Training and Documentation management experience preferred.
• Fluent in business English and German required.
• Good Interpersonal skills
• Good written communication skills
• Good team skills
• Analytical approach / attention to detail
• Self-motivated and organised
• Persuasive negotiating skills