Audit and Supplier Qualification Specialist

• Support, participate and host both Client and Regulatory audits
• Management of audit responses and ensure closure of actions within agreed timeframes
• On-going interaction with clients in relation to audits to ensure expectations and timelines are communicated in a proactive and timely manner
• Management and co-ordinate all aspects on site Supplier Management Programme, including supplier audits, preparation of QTA’s and supplier qualification
• Ensure on-going compliance with customer, regulatory and internal requirements
• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
• Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to the auditing Manager/designee
• Generation of SOP/Forms/JA's/WI's on MasterControl
• Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health & Safety meetings
• Interact and communicate daily with staff and support departments
• To undertake such tasks and to manage specific and/or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

• Bachelor’s or associate degree or Diploma / Certificate in Pharmaceutical and/or life science (e.g. quality assurance, or similar). May substitute experience in lieu of educational requirements
• 3-5 years previous supplier management and auditing experience is preferred with particular emphasis on hosting and conducting audits
• Good working knowledge of cGMP and associated regulations (Eudralex Volume 4
• ISO 13485)
• Experience in a similar role / working in Quality Assurance, Quality Systems, Compliance
• To have demonstrable experience within Quality Systems
• Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets
• Ability to manage multiple tasks and set priorities
• Good interpersonal skills
• Good Written communication skills

Lead auditor qualifications would be advantageous