Contract Quality Co-ordinator
Contract Type: Temporary
Job Elements: -
• 5 Month initial contract
• Provides support in coordinating the preparation and execution of external regulatory inspections, Health Authority and certifying body audits, so as to gain the best possible outcomes.
• Provides finished goods distribution compliance expertise to the organization as required.
• Responsible for executing all aspects of Supplier Quality and Compliance, alignment of Distributors Quality Systems with requirements of the QMS and for continuous improvement of distributors' quality and compliance performance.
• Responsible for guidance of distributors in resolution of distributor related non-conformances, CAPA and changes.
• Uses the Supplier Quality Tools, Quality Engineering (QE) principles, and practices to develop and optimize Distributors systems and processes and to Identify opportunities to continuously improve quality, cost, and time factors, consistent with business objectives.
The ideal candidate will have:
• Minimum of Degree, or equivalent in Chemistry, Biochemistry, Biology or Chemical Engineering discipline or 6 or more years supplier quality, regulatory or compliance experience in a highly regulated environment
• Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications.
• Good written and oral communication skills.
• Understanding in FDA CFR Part 820, Part 11, and ISO 130485 regulations is required.
• Ability to use PC''s and associated Microsoft software.
• Ability to effectively interface with governmental and independent auditors.
Petrie Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers.