QA Compliance Specialist (Arklow, Co.Wicklow, IE)

.

Reporting to the QA Compliance manager, the QA Compliance Specialist is jointly responsible for supplier and outsourced activity management, management of audits, inspections and CAPAs related to them, recall and delivery of GMP Training.

Key responsibilities will include, but are not limited to:

Ensure the effective implementation and continuous improvement of the Pharmaceutical Quality System (PQS), maintaining compliance with current regulatory and corporate quality requirements.

Provide complaint data for Product Quality Reviews (PQRs), Continued Process Verification (CPV) activities to support ongoing product and process performance monitoring.

Participate in the preparation of and follow up of regulatory and other external inspections of SII

Draft, review and approve written procedures and other documents including amendments to those documents (e.g. SOP’s WISOP’s, Quality Policy and other compliance related documents.).

Coordinate the preparation and submission of Quality Defect Reports as required.

Support any recalls as necessary and support any planned mock recalls

Coordinate the internal & external audit programmes and the self-inspection programme.

Participate in Internal Audits, Self-Inspections, and Visit and Communication on Quality (VCQ) activities, ensuring findings are addressed in a timely and effective manner.

Support of all inspections and customer audits, ensuring effective implementation of CAPAs arising from audits and complaints.

Participate in the preparation of and delivery of routine and annual GMP training on site.

Support continuous improvement on site and corporate projects as required.

Lead and participate in Quality Risk Management exercises, as required.

Work collaboratively with all site departments to provide support as required and to promote a strong GMP culture and ensure the highest standards of quality and compliance are maintained across the site.

Coordinate the on-site approval of new suppliers of excipients, active ingredients and packaging materials. Ensure that all required quality agreements are in place with material manufacturers and suppliers.

Prepare periodic Raw Material and Packaging Material Reviews in accordance with legislation. Co-ordinate with all relevant departments to agree a schedule and ensure the required information is provided in order to complete the review.

Obtain certification from suppliers (e.g. BSE/TSE, allergen, ISO etc.) as required, upon request by the Regulatory Affairs group.

Control and evaluate planned changes to approved Suppliers manufacturing processes and/or materials though the change management system.

Maintain the Approved Supplier List.

Participate in the preparation and review of protocols and reports for Ship to Stock materials and other reduced sampling and/or testing programmes

Perform formalised risk assessments for ascertaining the appropriate GMP for excipients as required by the relevant guidelines.

Support the Global Supply Project as required.

Requirements for the position:

Essential:

2+ years’ experience in the Pharmaceutical Industry and a 3rd level qualification in a scientific discipline or 5+ years’ experience in a quality function in the pharmaceutical industry

Strong communication, interpersonal and organisational skills

Strong IT skills

Excellent writing skills

Strong attention to detail and decision-making skills

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.