Crest Solutions are seeking a QC Specialist to join our team and work on our customer site in Carlow.

This role offers a fantastic QC Specialist opportunity for candidates interested in a new challenge in a cGMP regulatory environment. Join a supportive, growing team in a new state of the art Quality Operations laboratory. The QC Specialist will report directly to the QC Chemistry Manager and will help in the analytical method transfers and validation as well as routine testing.

What We Do

Crest Solutions are an engineering and software company that supply and support the resourcing of engineers, analysts, specialists and other professionals in this field. We are home to a vibrant group of professionals, working together to deliver to our clients. As a Gold Certificated company in the NSAI Excellence Through People scheme, Crest Solutions strives to guide many of Ireland’s most successful organisations to become more efficient, productive, flexible, competitive and innovative, through the development of great people.

Responsibilities and Tasks:

• Work as directed by the Associate Director Quality Control /Quality Control Manager (Chemistry) according to Company safety policies, cGMP and cGLP.
• Execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Participates in the method transfer of analytical techniques for Chemistry testing.
• Plan and perform multiple, complex routine/ non-routine methods and procedure when required.
• Participate in the peer review of analytical data
• Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues.
• Lead training of staff on technical aspects of the role.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Qualification of analytical equipment and related testing functions.
• Compliance with Standard Operating Procedures and Registered specifications.
• Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
• Lead laboratory Investigation Reports and deviations through the Non-Conformance procedures.
• Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
• Plan and implement procedures and systems to maximise operating efficiency
• Manage and contribute to the achievements of department productivity and quality goals
• Represent the QC Department on site/inter departmental projects.
• Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.
• May be required to perform other duties as assigned.

• 3-5 years of experience in a pharmaceutical laboratory, ideally in similar role.
• A good working knowledge of HPLC systems and software is desirable.
• A good knowledge of cGMP, GLP, Quality Management Systems.
• Method validation and method transfer experience would be Advantage.

• Great place to work
• Team of passionate people who love what they do
• Interesting projects, ability to implement your own ideas and improvements
• Opportunity to learn and grow