GMP Quality Systems Professional

7 days ago


Nenagh, County Tipperary, Ireland PE Global Full time

Job Description:

The Quality Specialist Quality Systems supports the Quality Systems activities in both Drug Substance and Drug Product facilities. This role participates as a member of the Quality Systems Team, ensuring timely completion of core functions in accordance with schedules and policies.

Responsibilities:

  • Timely completion of Quality Systems core functions.
  • Leadership on validation standards required for a Drug Substance and Drug Product pharmaceutical facility.
  • Validation documentation review and approval.
  • Laboratory quality assurance oversight.
  • Stability report review and approval.
  • Microbiology point of contact.
  • Quality agreement system management.
  • Annual review system management.
  • Quality oversight.
  • Supplier change evaluations quality role.


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