Job Description:
The QA Systems & Validation Specialist will play a crucial role in ensuring the compliance of SK biotek Ireland's Swords Campus with Good Manufacturing Practices (GMP) regulations. This 12-month contract position reports directly to the Quality Manager.
Main Responsibilities:
* Assess changes for GMP compliance according to site change control procedures for facilities, utilities, laboratory, and manufacturing equipment as well as control system changes.
* Review master and completed qualification and validation protocols, summary reports, and associated data for conformity to regulations, SOPs, specifications, and other applicable acceptance criteria.
* Provide expertise in validation ensuring compliance with current industry regulations, guidelines, and trends.
* Participate in cross-functional project teams as the quality assurance validation representative.
Key Skills and Qualifications:
* Bachelor's degree in Chemistry, Engineering, or a science-related discipline.
* At least 3 years of pharmaceutical experience, preferably in a QA role.
* Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.
* CQV, CSV, GMP, QA skills.
Working Relationships:
This role requires high-level interaction with various functions on site, including Manufacturing, QC, Utilities, and Engineering.
About the Team:
The Quality team at SK biotek Ireland is responsible for ensuring the highest standards of quality and compliance across all operations.