Quality Assurance Specialist

Pe Global

Tipperary, Cork

PE Global are recruiting a Senior QA Specialist for one of our clients based in Tipperary. Job Responsibility: Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities. Responsible for preparation and review of SOP related to Quality unit i.e. QA, QM and QA Validation and their issuance and archival. Responsible for QA documentation, Training and QA validation activities at site. Responsible for preparation and review of Process & Cleaning Validation protocol and compilation of process validation report. Responsible to co-ordinate with Quality control and Micro department for sample preparation and testing of Validation / Equipment, Utilities and System qualification / Re-qualification study. Responsible to conduct sampling activity as per the approved cleaning validation protocol. Responsible for preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System. Responsible for preparation and follow up for collection of data related to Validation Master Plan schedule. Responsible for preparation / Revision of validation as well as IPQA SOP’s. Routine IPQA activity and Calibration of IPQA instruments. Interested candidates should submit an updated CV, marked for the attention of Catherine O’Sullivan. Catherine.osullivan@peglobal.net or 021 4297900. This job originally appeared on RecruitIreland.com.

2555 days ago