Pharma Supplier Quality Specialist
Job ID: JOB-12468
Pharmaceutical Supplier Quality Engineer (Hybrid role)
Our Cork based Client has an exciting opportunity for someone experienced in Quality/ Supplier Quality to join their team. This person will provide Quality Assurance support and guidance for all pharmaceutical and medical device Suppliers, Contract Manufacturers and Distributors, following Pharma Quality Standards or local Procedures to ensure internal and external GxP (GMP,GCP,GLP,GDP) compliance across suppliers
- Technical Team Member which comprises of representatives from Purchasing, Supplier Quality and Business Units responsible for all aspects of Supplier Management.
- Demonstrates Technical skills in Commodity Management.
- Coordinate and schedule supplier audits and create detailed audit plans, reports, corrective audit plans and evaluate supplier responses in accordance with company SOPs and current GxPs.
- Perform GXP audits based on a defined audit plan within specific time constraints and maintain the Global Audit Schedule in a current state. Requires domestic and international travel.
- Responsible for supporting objectives of the SQ function in terms of Quality, Cost and Service.
- Supports Continuous Improvement of Quality & Quality Systems, Service Capability and Total Cost of Ownership throughout the Supply Chain.
- Supports/Manages investigation of Material Quality issues as they arise. Works with Supplier, Quality, Procurement & Business Units to resolve issues and disposition product.
- Initiate improvements to the Quality and Supplier Management Systems, ensuring compliance to all relevant Quality Standards and Regulatory requirements, including generation and amendment of applicable Standard Operating Procedures and related documents for compliance with GMP, GDP, GCP and ISO 13485. Works with Procurement, Supplier Engineering, Receiving Inspection & Business Units to ensure that components meet established requirements.
- Ensures that adequate Corrective Actions are identified, implemented and controlled by Suppliers
- Provides guidance to other functional areas in applying Supplier Management system requirements
- Contributes to the development, maintenance and improvement of Supplier Management Policies and Procedures.
- Communicates effectively with all Internal & External Stakeholders.
- Develops new Supply sources with Procurement Team. Onboarding and ongoing review of suppliers for Pharmaceutical suppliers
- Assesses and Approves Supplier Requested Process Changes
- Identifies, Supports and Leads Material Value Improvement Projects (VIP’s) throughout the Supply Chain.
- Degree or equivalent in a life science, or science related field
- Lead Auditing Certification (either by independent body or by corporate program).
- At least 5 years’ experience working in the Pharmaceutical, Devices or related industry with a working knowledge of the requirements of the MHRA and FDA essential, along with understanding of ISO requirements and experience of sterile products desirable.
- At least 3 years’ experience of internal and external audits from with a GMP / GCP regulated environment.
- Must possess a sound knowledge of national and international cGMP/ cGCP regulations and expectations to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being audited
For further information on this role in please contact Mark Wilson on 0860449473 or email email@example.com
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