Senior Quality Assurance Specialist

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Main Purpose of Job :

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.

Qualifications and Experience :

Join us and be part of building the bridge between life changing therapies and patients.