Senior Quality Assurance Specialist
The role is focused on ensuring processes align with global standards and regulatory requirements. As a senior quality assurance specialist, you will be the go-to expert for quality matters on site.
Key Responsibilities:
* SQC Preparation and Publication: Coordinate and prepare monthly SQC slides and summaries, finalize meeting minutes, and publish them in the local 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 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.
Qualifications:
* Education: BSc in Science or QA discipline.
* Experience: Proven ability to drive performance in another similar QA role.
* Skills: Organizational and planning skills, ability to streamline processes, excellent communication skills, and project management expertise.
* Attributes: Open-minded, enthusiastic, collaborative, and a champion of diversity and quality concepts.