Senior Quality Specialist

Title:

Senior Quality Specialist

Company:

Ipsen Ltd

Job Description:

We are excited to announce an opening for a Senior Quality Specialist role within our dynamic, innovative, and collaborative team. This position is perfect for someone with extensive experience in quality who is eager to contribute to a high-visibility role. The successful candidate will have the opportunity to become a qualified auditor,  Responsible Person and Responsible Person for import if they are not already at this level. Proven experience in quality (especially GDP), strong regulatory knowledge, and excellent communication skills are essential for this role.

As a Senior Quality Specialist, you will be an integral part of the Quality function within the UK & Ireland Commercial affiliate. You will work closely with and support the Senior Quality Manager/Responsible Person to manage all aspects of the Quality Management System (QMS), ensuring that your covered regions are GxP compliant and inspection ready.

If you’re passionate about quality, have a curious and proactive mind set and are ready to take on new challenges with a high performing team and department, we would love to hear from you!

Responsibilities:

• Take ownership and provide support on QMS processes (Deviations, CAPA & Change Controls) including Root Cause Analysis, Risk Assessment, Action completion, and timely closure of records.

• Act as a Training Specialist – accountable for the UKIE Training Matrix, manage training within iLearn, conduct monthly Quality Inductions, and provide general business support.

• Act as an SME for Quality Risk Management – chair Risk Management Committee Meetings, ensure all identified GxP risks are captured and progressed, complete trending, reporting, and measure process effectiveness.

• Manage GxP Change Controls including oversight, progression of records, trending, reporting, and measuring process effectiveness.

• Log and manage Temperature Excursions.

• Manage controlled documentation including the completion of gap analyses vs global document updates.

• Lead the completion of Product Quality Review.

• Responsible for the management of the Quality functions section of the RQ SharePoint.

• Provide SME insight and content for Management Review activities.

• Complete checks to confirm that products imported into Great Britain and requiring QP certification are locally released.

• Engage with local and global supply chain colleagues to maintain awareness of planned shipments and product types.

• Receive, log, and manage Product Quality Complaints including engagement with manufacturing sites on investigation reports.

• Complete weekly reconciliation reports.

• Complete trending reports on complaint types and measure process effectiveness.

• Support the Senior Quality Manager in compiling the annual audit risk assessment and schedule.

• Responsible for the annual mock recall.

• Complete Internal and External Vendor Audits. While providing support during Ipsen local and global inspections and audits.

• Complete activities conducted by the RQ Officer in times of absence:

• Administrative activities associated with the electronic document system (Easidoc).

• Creation & Allocation of training in the electronic training system (iLearn).

• Generation of KPIs and metrics.

• Complete delegated activities for the Responsible Person (UKIE) in times of absence.

• Additional project work as defined in annual objectives & development plan.

Essential requirements:

• Educated to Degree level (life sciences) or equal experience.

• Previous experience within a Quality role.

• Previous experience within the pharmaceutical industry

• Detailed knowledge of EU Good Distribution Practice and MHRA/HPRA requirements.

• Experience of participating in both internal GxP audits and regulatory inspections.

• Knowledge and training within GxP.

• Experience and advanced knowledge of Microsoft Office.

• Excellent verbal, written, analytical, and interpersonal skills.

• Self-motivated, organised, and able to problem solve.

Preferred requirements:

• Experience as a Responsible Person for Import (RPi).

• Quality Management System Lead Auditor or Pharmaceutical GMP Lead Auditor Qualification

• Membership of an acceptable professional body.

IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.