Quality Specialist - Supply Chain
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| Job Type | Fixed Term |
| Area | Dublin, Ireland |
| Sector | QualitySupply Chain |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2099 |
| Job Views | 287 |
- Description
- We are recruiting for a Quality Specialist, Supply Chain on a fixed term contract for our Clients Global Supply Chain Quality team in Dublin city centre. In this role you will provide QA support for on-site Supply Chain departments and regional/global teams. Ensure activities are carried out as per GDP guidelines. Carry out activities such as internal auditing, non-conformance, change control, update and review of SOPs and training. Carry out management of distributors in EEMEA region including setup, annual requalification, temperature excursion management, New Product Introduction & release of orders in SAP.
Why you should apply:
This is a great opportunity to join a company that offer a career of limitless possibility
There is a culture of innovation, inclusion and development, and are recognized as a great place to work
What you will bedoing:
Support all local/regional Quality requirements and implement as appropriate for the Supply Chain functions
Ensure alignment between Corporate Standards, Policies and Procedures and regional/local quality SOP’s.
Support Integration projects as required
Responsible for the Document Controller functions on One Vault.
Support the local/regional Change Control & Risk Assessment System
Conduct self-inspection of local QMS to evaluate compliance, providing reports to Management Team including the RP.
Maintain CAPA / Non-Conformance program and initiate Corrective Action plans with department managers as appropriate.
Provide KPI reports to management including distributor performance, audit results and status of Corrective Actions.
Ensure all EEMEA Distributors meet the requirements of company Quality Policies and Procedures.
Support onboarding/discontinuation of Distributors via Change Control
Perform risk assessments on all EEMEA Distributors to validate compliance with Quality System and Technical Agreements.
Support GxP compliance of Distributors in EEMEA
Perform QA actions for all Distributor Markets new product launches including bona fides checks, Technical Agreement update, site record update in Global TrackWise etc.
Act as QA Representative for the Indirect Markets Supply Team.
Support audits conducted by Corporate Audit including management of responses to audit findings.
Provide support for mock recall/recall activities within distributor markets.
Release Product for distribution where country of destination is not listed on ECR, using SAP transactions.
Support quality improvement initiatives across EEMEA/WEC region as part of regional quality management review.
Act as QA representative for supply chain expansion and compliance projects
Support Manufacturing and Commercial Quality sites for local quality requirements.
Support APIL’s inspection readiness program.
Ensure obligations from Good Distribution Practices, Medical Device Regulation and corporate policies are incorporated into Quality management system.
What you need to apply:
3 years college education in a medical/scientific related field.
3 years’ experience in a quality related position or production in the pharmaceutical or medical device industry.
Previous administrative experience, working at a senior level, ideally in a pharmaceutical or medical device company.
Previous experience with ISO standards and GMP/GDP quality systems required for pharmaceutical/ medical device industry.
ISO 9001:2015 Internal Audit Certification strongly preferred
Previous TrackWise experience is a strong advantage
