Senior Quality Assurance Manager
vor 4 Wochen
The role involves leading 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.
Main Responsibilities:- 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.
- Implementation of the defined quality objectives for their QMS areas.
- 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 assist with GMP internal audits.
- Coordinates and 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.
- Control and further development of the QMS areas under their oversight.
- Supports tasks within wider QMS or business areas as required.
- Leads and 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.
- Supports in the execution of training for quality & other relevant personnel.
- Undertakes and supports quality related tasks associated with strategic projects.
- 5 Years' Experience within a quality systems related role (ideally pharma related)
- Ideally 2 to 3 years experience of leading teams/people with experience in disciplinary processes.
- Demonstrable experience within Quality department, ideally in a packaging or pharmaceutical company
- Knowledge of packaging equipment, facilities and processes
- To have good knowledge of Quality Assurance inspection requirements
- Risk Analysis and Associated Methodology
- Received formal training in GMP requirements from Quality Assurance
- Fluent in business English and German
- Good Interpersonal skills
- Good written communication skills
- Good numeracy / literacy
- Good team skills
- Technical aptitude
- Strong commitment to Quality Assurance principles
- Analytical approach / attention to detail
- Professional
- Self-motivated and organised
- Persuasive
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides integrated services to the pharmaceutical and biotechnology industries. We are committed to helping our clients bring life-changing therapies to market.
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