About the Role:
* We are seeking an experienced Quality Assurance Specialist to oversee quality processes and ensure compliance with global standards and regulatory requirements.
* The successful candidate will be responsible for coordinating SQC preparation and publication, managing deviation processes, and ensuring alignment with global standards.
* This role requires strong organizational and planning skills, excellent communication skills, and project management expertise.
Key Responsibilities:
1. Coordinate and prepare monthly SQC slides and summaries, finalize meeting minutes, and publish them in the local DMS system.
2. Represent the site in global meetings, handle communication, and address questions related to deviations, audit observations, and CAPAs.
3. Calculate and review deviations to ensure compliance.
4. Ensure alignment with global standards, act as a subject matter expert, and resolve PQS internal issues.
5. Utilize statistical tools for data preparation, extraction, and analysis to support business compliance.
6. Interpret quality metrics and trends to identify risks and deviations, ensuring timely actions are taken.
8. Identify gaps, implement solutions, and champion innovation to ensure sustainable quality management.
9. Design, develop, and deliver GMP compliance training and awareness campaigns.
10. Promote and manage change processes effectively, engaging others and making timely decisions.