Quality Manager & Responsible Person (RP)

• Support the implementation & maintenance of Healthxchange’s commitment towards GDP, GMP and GPhC Regulatory standards
• Provide daily support towards Healthxchange’s operations licences at all sites
• namely WDA(H) & MS licenses
• Assist the Head of Quality in implementing and maintaining applicable standards across all Healthxchange operations
• Act as the Responsible Person
• Oversight and maintenance of the Quality Management System (QMS) including document control, change management, deviation and CAPA management, complaint management and validation activities
• Assist in the development and improvement of procedures, protocols and departmental documentation
• Support customer, supplier qualification and re-qualification
• Outsourced activities qualification
• Partake and support internal and external audits to assess compliance whilst continually removing risk from Healthxchange operations
• Perform quality risk assessments
• Perform investigation of temperature excursions and impact assessments
• Management of the product recall
• Provide guidance and support to cross-functional internal teams on QA related topics
• Drive continuous improvement initiatives to enhance QA systems, processes & performance
• Maintain and support GDP/GMP training to internal colleagues to ensure staff are consistently aligned with applicable industry regulations and expectations
• Collaborate with the Head of Quality to manage and report QA KPIs that assess Quality effectiveness across Healthxchange, including trend analysis and identification of improvement opportunities
• Collate information and host Quality Management Review meetings
• Ensure timely resolution of QA related issues and deviations to minimize risk to customers, patients and Healthxchange supply chain of products
• Support the Head of Quality in communications with external agencies and clients in all matters pertaining to QA/Regulatory
• Other duties which may be reasonably required from time to time, including delegated duties during the absence of colleagues

• Batchelors degree in related field (Quality Assurance, life sciences etc)
• Minimum of 3 years’ experience in a QA role in pharma industry (GDP, GMP, GxP)
• Experience in GxP QMS management
• Previous RP experience on WDA(H) (preferably with the same licence conditions)
• Strong analytical, problem-solving and decision-making skills
• Effective communication and interpersonal skills
• Excellent attention to detail with strong analytical skills
• Ability to work independently and collaboratively across multiple cross-functional departments
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

Preferred knowledge of Lean Six Sigma principles and methodologies

• Company pension
• annual performance bonus
• 25 days holiday plus bank holidays (and increasing with service)
• staff discount
• staff social events
• access to Health Assured EAP