Description
Would you like to work within a global healthcare company devoted to improving life through the development of products and technologies in the area of diagnostics, medical devices, nutritionals and branded generic pharmaceuticals in 150 countries?My Client is currently seeking a Senior Supplier QA Auditor and this role will involve the following:
Major Responsibilities
- Independently conducts and leads audits across company's Supplier and TPM network.
- Identifies compliance risks to current standards / regulations and may guide in the planning and execution of Quality System improvements.
- Ensures compliance to Division and Corporate policies and procedures by promptly reporting non-compliance issues
- Provides guidance and trains colleagues; provides oversight to one or more junior level auditors
Expertise and Problem Solving
- Participates as SME in audits; provides compliant, and strategic solutions to complex quality issues.
Project Management
- Leads projects that are cross-functional in scope; directly influences project direction and scope; champions new initiatives and acts as the catalyst for change within and potentially across Divisions
Regulations
- Maintains and demonstrates understanding of global standards, regulations and regulatory bodies
Supervisory / Mgmt. Responsibilities
- May assume managerial responsibilities as needed
Education / Experience
- Apprenticeship or Bachelor's degree in Life Science, Engineering or closely related discipline is required; minimum of 8 years of related experience in the medical device / pharmaceutical industry
Background / Skills / Knowledge
- Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; IVDD; etc.
- Trained in auditing techniques; Certified Auditor qualification or equivalent is required.
- Excellent written and verbal communication skills
Accountability / Scope
- Reports to Manager, Global Compliance and Auditing
- Carries out assigned duties and tasks related to area of responsibility with management guidance; may be responsible for decision making.
Logistics
- Minimum 50% travel
To hear more about the role please apply below with an up to date CV or call me Anna Mooney .