CLS is currently looking to recruit an experienced Quality Manager to oversee their Quality and Validation functions in our MedPharma facility in Galway city. This is an exciting role in a fast-paced commercial environment. The person appointed will have the full support of an existing team in quality and will continue to manage a system that is up to date and fully compliant.

  • Maintain and improve the Quality System to realize the highest quality standards attainable for all activities conducted by the company
  • Represent the QC department in regulatory and client audits and ensure the timely close out of actions/ recommendations identified from all audits
  • Support the commercial requirements of the business with input and collaboration across business units and through departmental budgeting and business support.
  • Ensure that data integrity is maintained as per ALCOA+
  • Author, reviewer and approver of SOPs, analytical validation protocols and reports.
  • Operate CAPA/deviation and customer complaints and identify and implement continuous Improvement programs as appropriate
  • Investigate out of specification results utilizing Structured Problem Solving and Root Cause Analysis tools and implementing effective corrective and preventative actions while ensuring all investigations are closed within the specified lead-time

Professional Competencies:

  • Relevant 3rd level qualification in science
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent combination of education, training, & experience
  • Demonstrated knowledge of quality systems, FDA and EU guidelines as they relate to analytical testing
  • Experience with regulatory inspections
  • Strong Interpersonal skills and professional skills to interact at all levels including senior management, colleagues and clients
  • Well-developed and proven analytical skills

Skills

High level of integrity, team orientated with a methodical, analytical and problem-solving mindset. Proactive and self-motivated with great people skills, Experience in quality management, Quality Control and GMP.

Apply for this position

Suitable applicants are invited to email their CV with cover letter to: hr@cls.ie

We will reply only to those applicants that we are progressing to the next recruitment stage.