About the Role
We are seeking a dedicated Quality Assurance Specialist to join our thriving team. As a senior member, you will be the go-to expert for quality matters on site, ensuring that processes align with global standards and regulatory requirements.
The ideal candidate will have a proven ability to drive performance, excellent decision-making skills, and the ability to meet strict deadlines in a similar QA role.
* SQC Preparation and Publication: Coordinate and prepare monthly SQC slides and summaries, finalize meeting minutes, and publish them in the local DMS system.
* Deviation Process Management: Represent the site in global meetings, handle communication, and address questions related to deviations, audit observations, and CAPAs.
* Deviation Event Category Limits: Calculate and review deviations to ensure compliance.
* QRM Process: Ensure alignment with global standards, act as a subject matter expert, and resolve PQS internal issues.
* PQS Statistical Tools: Utilize statistical tools for data preparation, extraction, and analysis to support business compliance.
* Quality Metrics Monitoring: Interpret quality metrics and trends to identify risks and deviations, ensuring timely actions are taken.
* Quality Plan Execution: Execute the site quality plan and deliverables, reporting on quality and compliance issues.
* Inspection Readiness: Maintain ongoing inspection readiness, manage remediations, and ensure compliance with GMP and quality processes.
* Continuous Improvement: Identify gaps, implement solutions, and champion innovation to ensure sustainable quality management.
* Training and Awareness: Design, develop, and deliver GMP compliance training and awareness campaigns.
* Change Management: Promote and manage change processes effectively, engaging others and making timely decisions.