QC Senior Analyst

Takeda (Dublin, Ireland) 6 days ago
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JOB PURPOSE:

The QC Senior Analyst has an important role to play in the start-up of the TIL GC Quality Control laboratory in a new biologics manufacturing facility and the routine operation of the QC laboratory when start-up is complete.  The QC Senior Analyst will have specific and varying duties and some key tasks and responsibilities are outlined below.  During start-up flexibility is important and responsibilities may change or other duties may arise.

RESPONSIBILITIES:

Quality Systems:

  • Contribute effectively to the design and implementation of quality systems in the QC laboratory
  • Work with other QC personnel in the preparation and review of the required documentation in the QC laboratory, including Standard Operating Procedures, Analytical Procedures, Analytical Worksheets and Material Specifications.
  • Participate, as directed, in the following activities in the QC laboratory:
    • Equipment Calibration and Maintenance
    • Reference Standard Management
    • Purchasing
    • Laboratory Auditing
    • LIMS data management and maintenance
    • Lean Laboratory Techniques

      QC Laboratory Activities:

  • Provide expertise in a variety of analytical test procedures.
  • Schedule other analysts work
  • Review of other analysts documentation and test results
  • Stand in for QC Executive when required
  • Carry out sampling and analytical testing of raw/starting materials, Master Cell Stock, Drug Substance and Drug Products according to approved TIL GC procedures and plant schedules.
  • Ensure that all testing information is recorded accurately and completely according to TILGC procedures.
  • Ensure that any deviations or out of specification (OOS) results are reported immediately to the QC Executive so that corrective action may be taken.
  • Lead root cause analysis in deviation investigations, OOS investigations, and change proposals. Determine CAPAs required preventing reoccurrences.
  • Provide samples to contract testing laboratories and liaise with these laboratories as required.
  • Training of analysts

    Validation:

  • Review of method transfer and method validation protocols and reports.
  • Carry out method transfer and method validation work as required, to meet project deadlines.
  • Review equipment qualification documentation for QC Laboratory equipment.

    Good Laboratory Practices:

  • Ensure that Good Laboratory Practices are followed at all times.
  • Ask, if in doubt, about any particular practice or unusual finding.
  • As a member of the quality function, work with other departments to promote a culture of compliance to Good Manufacturing Practice within the plant.

    GENERAL RESPONSIBILITIES:

  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager
  • Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times
  • Prepare for and support internal and external audits (FDA, HPRA, corporate).
  • Prepare and review documents as required

    EDUCATIONAL REQUIREMENTS: 

  • Minimum of a BSc Degree (life science)

    RELEVANT EXPERIENCE:

  • A minimum of 4 years' work experience in a regulated GMP/GLP environment
  • Practical experience with HPLC systems and troubleshooting
  • Practical experience in cell counting, morphology and flow cytometry is desirable.
  • Experience with writing and reviewing SOP's / validation protocols
  • Experience with Method transfer / validation
  • Experience working in an Biologics facility, desirable but not essential

    SKILLS/COMPETENCIES:

  • Good time management
  • Experienced in technical writing
  • Ability to work on own initiative in an unsupervised manner
  • Ability to adapt to changing priorities
  • Ability to work independently and meeting established timelines.
  • Knowledge of cGMPs.
  • Successful track record in achieving goals as part of a team within a growing, dynamic environment
  • Demonstrated adaptability and flexibility to support a growing organisation.
  • Self-motivated and ability to work under pressure

Grange Castle, Ireland

Employee

Regular

Full time


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