Description:
Reporting to the Head of Quality, the Senior Specialist Quality Assurance (QA) will lead the QA function, ensuring adherence to quality and compliance requirements. This role involves managing the QA team and contributing to the overall success of our organization.
Principal Responsibilities:
- Support the Head of Quality in managing the PQS.
- Oversee operational aspects of Quality procedures, including Deviations, CAPAs, Change Control, Documentation Management, GMP Training, Internal Audit, Complaints & Recalls, and more.
- Manage resources, providing training to the QA team for effective execution of procedures and processes.
- Collaborate cross-functionally with other departments on various activities, including validation support, materials management, and manufacturing support.
- Ensure QA oversight across functions and approval of SOPs and controlled documents.
- Develop and own Quality metrics, utilizing data to drive on-time delivery of records and fostering a high-performance culture.
- Own the QA training program and drive a culture of continuous improvement.
- Act as the system owner for identified QA systems in the Validation Master Plan.
- Manage the QA team, focusing on building a high-performance culture.
- Identify and implement improvement projects, supporting the development of systems for Quality record management and metrics.
- Develop QA capabilities and services to support the delivery of commercial revenue.
- Establish and maintain processes to support the QP team in preparing, reviewing, and communicating quality records for release activities.
- Contribute to Supplier Management activities, including scheduling and executing qualification activities.
- Ensure inspection readiness of the QA function and support Compliance and regulatory inspections.
- Serve as a delegate for the Head of Quality, as required.
Experience & Qualifications:
Essential
- Primary degree in a relevant Life Sciences discipline.
- 5-10 years of QA experience in a GMP-regulated pharmaceutical/biopharmaceutical company.