• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland +353 21 206 6178 info@prochem.ie
  • QC Specialist – Co Carlow

    Role Summary

     

    • Our client based in Co. Carlow offers a fantastic Quality Control Specialist opportunity for candidates interested in a new challenge in a cGMP regulatory environment.
    • The successful candidate will join the quality team, a supportive, growing team in the analysis of Biologics and Vaccines 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.

     

    Core Duties and Responsibilities:

     

    • Work as directed by the Associate Director Quality Control /Quality Control Manager (Chemistry) according to Company safety policies, cGMP and cGLP.
    • Drive compliance with company’s Global policies, procedures and guidelines and regulatory requirements and 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.
    • Initial Travel Requirements: Occasional travel may be required for training purposes.

     

    Minimum Qualifications and Experience:

     

    • Bachelor’s Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline.
    • The ideal candidate will have 3-5 years’ 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.
    • Strong interpersonal and communication skills (verbal and written).

     

    To Apply

     

    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    14 Danville Business Park, Kilkenny, Ireland
    +353 56 77 90100
    recruitment@prochem.ie

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.