• 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 Bioanalytical Chemist – Co. Dublin

    Role Summary

     

    • A new opportunity has arisen for the position of a QC Analyst at our client’s busy pharmaceutical site in Co. Dublin.
    • The QC Analyst role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of the new strategic Drug Substance facility.
    • This tremendous opportunity will be responsible for verifying the raw materials analytical methods and performing supplier qualification.
    • The successful candidate will be key in the layout of the lab testing to ensure the process is streamlined and in line with site lean methodologies.
    • The candidate will be the key talent in analytical raw materials techniques and in Pharmacopeia methods.
    • The facility will utilize the latest innovations in technology and automation and latest in analytical technics. The candidate will work with a high performing cross functional team of talent sourced from across the company and the biotechnology industry. Together, the team will build the future of the biologics facility through a Quality culture that delivers unconstrained supply, Right First Time to patients through an inspired team.
    • The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise.
    • The full analytical scope will incorporate micro, chemistry, bioassay, raw materials, stability and in-process. Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc.) will allow the candidate challenge current thinking in designing for the future.
    • The candidate will have responsibilities in analytical transfer and qualification of methods.

     

    Core Duties and Responsibilities:

     

    • The desire to continuously learn, improve and develop.
    • Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers.
    • Perform and carry out a variety of routine analytical techniques including but not limited to HPLC, HIC, CE, IEX, HP-SEC, UV, pH, Colour, Osmolality, Degree of Coloration and Appearance in compliance with GMP requirements.
    • Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
    • Support the laboratory testing schedule to achieve an efficient QC system.
    • Receive and manage samples that come into the lab for stability, in-process and release testing.
    • Solution preparation, cleaning, routine equipment maintenance and system set-up.
    • Writing and update of SOPs.
    • Maintain good housekeeping and hygiene within the laboratory.
    • Calibrate and maintain all designated laboratory instruments.
    • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
    • Ensure training is current for all job functions performed.
    • Assist in training new QC Analysts on routine procedures and practices.
    • Order, stock and receive laboratory supplies.
    • Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
    • Ensure that cGMP standards are maintained at all times.
    • Delivery of area performance to meet or exceed performance or quality goals.
    • Promote and participate the implementation and maintenance of the relevant safety programmes.
    • Participate and Comply with the site Quality Management System requirements.
    • Responsible for driving a culture of Continuous Improvement by deploying site Six Sigma tools.
    • Possibility of shift work.
    • This position will be on days with the possibility of shift work when required.

     

    Minimum Qualifications and Experience:

     

    • Degree qualification (Science/Quality/Technical)
    • Master preferred
    • Preference Lean Six Sigma
    • 1-3 years industry experience with significant knowledge and experience in working in a Raw material lab unit and working with contract labs
    • Experienced in testing as per the pharmacopeia
    • Working knowledge of QC Systems (Empower, elogs, Electronic Lab Notebook, LIMS)
    • Ability to respond to changing priorities
    • Strong organisational skills
    • Good verbal and written communication skills
    • Excellent troubleshooting and problem-solving skills
    • Good attention to detail
    • Ability to think logically and be proactive.
    • Ability to work as part of a team and on own initiative in a constructive manner
    • Flexible and self-motivated

     

    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.