• Contract
  • Meath

Website Asset Recruitment

Asset Recruitment

Ref: 01080

QA Systems Lead

Responsibilities:
Responsible for the release of incoming goods, products for which production or packaging is outsourced, and products and processes in full compliance with quality procedures, legal guidelines, quality guidelines and market authorization. Responsible for advice on and improvements of quality related issues, in order to ensure an optimal quality of released products and processes. Will understand the quality requirements for the introduction of materials to site, will have the capability to communicate the requirements to suppliers and will use good documentation practices and be capable of implementing these at a local level. Minimal work direction needed, highly skilled and knowledgeable to the position.

Role
• Manage of members of the QA Systems team
• Responsible for providing oversight and coaching to the QA Systems team on the site Quality Management Systems (Change Controls, Documentation Management, CAPAs, Audit Readiness, Supplier Quality Management , and Pest Control).
• Monitor and support the performance of the site Quality Systems according to the company and cGMP standards
• Implementing industry best practices specific to Quality System processes that promote manufacturing, materials management, validation, and Quality Control Laboratory readiness.
• Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement
• Implementing efficiency improvements in Quality Systems continuously and participating in site projects and initiatives.
• Preparation/review, and or approval of GMP documentation, including SOPs, policies, analytical documentation as required.

Skills & Qualifications
• A degree in biochemistry, chemistry or engineering related discipline
• 6 years+ working knowledge in the biotechnology and/or pharmaceutical industry.
• Demonstrated ability of Quality Management System tools and continuous improvement.
• Demonstrating ability in leading a team
• Ability to work independently and effectively in a fast-paced environment delivering to a high quality standard.
• Strong technical aptitude (ability to read & comprehend technical documentation and execute procedures) and demonstrated experience interfacing with regulators is desirable.
• Established partnership, negotiation & conflict resolution skills.
• Exceptional analytical, problem-solving & root-cause analysis skills.

 

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