Transforming Lives Through Therapies. Global Impact Ahead.
We are PCI.
Our investment is in People who make a difference, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of quality systems.
We are seeking a Quality System Specialist to join our team.
Main Purpose:
The role entails implementing and executing tasks related to day-to-day quality systems aspects. The individual will take responsibility for quality assurance matters around processes and documentation within the City North business unit.
Main Responsibilities:
* Developing and reviewing Standard Operating Procedures (SOPs), Work Instructions, and Forms.
* Reviewing Deviations, Events, Non-Conformance Reports, Corrective Action Requests, risk assessments, and providing support to departments on completion of records.
* Following up on change control actions with appropriate action owners and driving for timely closure of actions.
* Preparing Quarterly reports for each site.
* Preparing Product Quality Review reports (PQRs).
* Preparing Monthly Metrics and driving for closure of records.
* Completing complaints investigations and assisting with close-out of complaints.
* Performing cGMP internal audits.
* Assisting in the performance of external audits.
* Responsible for executing training for quality personnel.
* Assisting with preparation for customer/regulatory audits.
* Assisting with audit requests during customer/regulatory audits.
* Preparing responses to customer audits.
* Hosting/attending cross-departmental meetings as required as quality representation.
* Identifying and supporting opportunities for improving processes and/or procedures.
* To undertake such tasks and manage specific or ad-hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
Join us and be part of shaping the future of quality systems that connect life-changing therapies with patients.