Biotech NPI QC Analyst

2 weeks ago

Dublin, Dublin City, Ireland TN Ireland Full time

Employment Type: Contract

Experience: 3+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. This is an excellent opportunity to gain experience in Ireland's leading aseptic manufacturing plant.

Responsibilities:

  1. Under minimal supervision, responsible for one or more activities in QC including analytical testing, characterization, sample and data management.
  2. QC Representative for NPI activities and routine Product meetings.
  3. Assist with activities related to QC projects and/or QC tasks within Site projects.
  4. Plan and perform non-core testing related to NPI activities.
  5. Manage all sample management activities related to NPI activities throughout the site.
  6. Create/own and approve protocols, sample plans, SOP and documentation related to NPI.
  7. QC Representative responsible for Method Validation and Transfers co-ordination and readiness.
  8. Responsible for own training and safety compliance.
  9. Sample shipments and temperature monitoring activities for NPI activities.
  10. LIMS data coordination of non-core (NPI) activities.
  11. Contribute to team by ensuring the quality of the tasks/services provided.
  12. Contribute to the completion of milestones associated with specific projects or activities within the team.
  13. This role will support QC and manufacturing operations; extended hours and weekend work flexibility may be necessary.
  14. With a high degree of technical flexibility, work across diverse areas within QC.
  15. Plan and perform analyses with great efficiency and accuracy.
  16. Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
  17. Report, evaluate, back-up/archive, trend and approve analytical data.
  18. Troubleshoot, solve problems and communicate with stakeholders.
  19. Initiate and/or implement changes in controlled documents.
  20. May train others as necessary.
  21. Participate in audits, initiatives and projects that may be departmental or organizational in scope.
  22. Write protocols and perform assay validation and equipment qualification/verification.
  23. Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  24. May contribute to regulatory filings.
  25. May conduct lab investigations as necessary.
  26. Evaluate lab practices for compliance on a continuous basis.
  27. May represent the department/organization on various teams.
  28. May interact with outside resources.
  29. Create APPX data files and randomisation memo to facilitate data analysis.
  30. LIMS data coordination of commercial and import testing on site where applicable.
  31. May provide technical guidance.

Requirements:

  1. 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
  2. Strong background in Chemistry and Analytical testing is required.
  3. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
  4. Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories.
  5. Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
  6. Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
  7. Strong communication skills (verbal and written) at all levels.
  8. Strong technical writing skills for GMP documentation (e.g. investigations, procedures, change controls).
  9. Demonstrated ability to work independently and deliver right first-time results.
  10. Working knowledge of aseptic compliance within the manufacturing environment.
  11. Auditing documentation and operation process.

Package:

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