Cleaning Support Specialist

Website TPM05414

Summary:
Our client, a biopharmaceutical company located in South Tipperary, is seeking a Cleaning Support Specialist. The successful candidate will be responsible for issuing and management of cleaning changes and documentation as well as reviewing and incorporating relevant updates as communicated via the Technical Team Lead.

Responsibilities:

  • Responsible for management and tracking of Cleaning validation parameters and commitments.
  • Support for Cleaning Investigations.
  • Compilation of CPV reports, CAR, and APRs.
  • Ownership and management of changes.
  • Generation and tracking of cleaning campaign documentation.
  • Stewardship of validated campaign data.
  • Liaising with product teams to align turnaround targets.
  • Investigation support for Cleaning QNs.
  • Assessments of OOTs.
  • Support project assignments as required.
  • Completion of validation reports.
  • Maintain accurate records in compliance with GMP expectations.
  • Understand and internalise procedures relevant to GMP operations.
  • Communicate clearly and concisely on technical issues.
  • Deliver project goals on time.

Qualifications & Experience:

  • Degree qualification in a science or engineering-related discipline.
  • Knowledge of GMP standards.
  • Previous experience in API or Drug Product manufacturing is desirable.

To apply for this job email your details to orla.daly@tandempm.ie.