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