18307-Supply Chain QA Auditor-Dublin Contractor

This role is an 11 Month Hybrid contract with a view to extension.

Role will be 3-4 on site and 1-2 days from home.

Purpose

The Supply Chain QA Auditor conducts routine audits of data, information, procedures, equipment, systems (including computer systems), and/or facilities to ensure compliance with SOPs and GMPs, and worldwide regulations. Review and approve production and analytical documentation accompanying the release of API, Safety Assessment, or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements. In addition, the Auditor communicates and resolves audit comments with client areas. Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards. Issue reports summarizing deficiencies and works with areas to execute remedial action. Notify appropriate management of inspection results. Works with moderate work direction and is skilled and knowledgeable about the position.

Responsibilities

• Be involved in material qualification through gathering reviewing and approval of supplier documentation.
• Be responsible for the quality aspects of receipt and release of incoming materials for the site.
• Raise and manage change controls that reflect the suppliers’ changes – to ensure that changes are communicated, evaluated, risk-assessed, and implemented in a manner consistent with our client’s policies. Liaise with suppliers to accurately evaluate and implement the suppliers’ changes. Participate in Material Review Board activities to control such activities.
• Raise and manage supplier complaints to assess and resolve issues with incoming materials; work with the supplier to prevent future reoccurrences.
• Be involved in all quality-related activities for the warehouse and dispensary which are required by our client’s Manufacturing Division Quality Manual or with the potential for impact on product quality, patient safety, or data integrity. Including quality review and approval of deviations, change controls and Standard Operating Procedures (SOP’s).
• Raise and manage change controls for BOMs, and routings for internal manufacturing (in conjunction with the SAP Process and Data stewards).
• Manage or participate in Supply Chain-focused and cross-departmental projects as needed.
• Will work closely with stakeholders and SMEs from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
• Liaise with above site groups for material and supplier management
• Responsible for adhering to site and above site KPI, tracking and reporting of same.

Requirements

• Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career.

General requirements:
• This role requires a QA Specialist with a minimum of 5 years’ experience in Quality Assurance or Supply Chain, Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
• A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.

Technical requirements:
• Must have at least 2 years of experience in performing the supply chain and quality related activities in a regulated environment.
• Preferred to also have a background in Quality Control Testing including method validation/verification/qualification or Supplier Management.

About you:

• The motivation to be an inspiring member of a high performing team.
• The desire to continuously learn, improve and develop.
• A great communicator, decisive decision maker and proven ability to deliver excellence.
• Confidence to direct off-site suppliers to the project, willingness to support the team and a laser light focus to deliver excellence.
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Experience with new product introductions and/or process qualification/technology transfer.