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
- Ensure that data integrity is maintained as per ALCOA+
- Author, reviewer and approver of SOPs, analytical validation protocols
- 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
- 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
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: email@example.com
We will reply only to those applicants that we are progressing to the next recruitment stage.