Document management

• Approval and issuance of batch records and other GxP documents as required.
• Coordinate issuance and tracking of controlled documents.
• Issue of batch documents and collation and review of records post manufacture to ensure appropriate GMP standards are maintained.
• Collation of completed GMP documentation and coordination of associated archiving activities.

Vendor management

• Document risk assessments of vendors quality systems by means of on-site audits, questionnaires or other tools.
• Ensure designated vendors are audited on a regular basis to ensure regulatory and quality standards are met and escalate vendor quality issues and risks to management.
• Coordinate vendor qualification and audit schedules.
• Arrange and perform audits of suppliers and vendors.
• Provide subject matter expertise on vendor management practices during client audits.

Internal auditing and self-inspections

• Provide QA support during regulatory inspections and client audits.
• Complete internal audits and self-inspections.
• Tracking completion of GMP self-inspections and audits.
• Track actions arising from Inspections, audits, and self-inspections.

Support Local Quality Compliance Council

• Generate quality metrics and trend data to support the on-going management of compliance through the Quality Council.

Training

• Perform training relating to the quality systems and GxP.

Batch release and batch record review

• Perform QA release of product.
• GMP review and approval of batch records and other completed GMP records

Continuous improvement

• Identify opportunities to quality management for improving processes to benefit quality, compliance, business efficiency.
• Implement initiatives to benefit quality, compliance, business efficiency.

Quality Risk Management

• Act as quality oversight for risk identification and assessment processes.

Functional Competencies (Technical knowledge/Skills)

• Highly motivated with a strong commitment to continuous learning and professional development
• Demonstrates intermediate proficiency in desktop software applications, including Microsoft Office, Excel and Adobe PDF
• Culturally aware, with the ability to think and work effectively in a global environment, supported by strong interpersonal, verbal and written communication skills
• Good understanding of Good Manufacturing Practice (GMP) within the pharmaceutical industry, with demonstrated ability to apply regulatory standards and guidelines
• Advanced knowledge of elements of the Quality Management System and continuous improvement methodologies
• Demonstrates a strong sense of urgency when addressing issues and ensures timely completion of commitments
• Effectively communicates quality issue, along with potential recommendations, to various functional groups.
• Handles highly confidential information with professionalism and discretion
• Capable of training and supporting new and less experienced Quality team members
• Able to work independently and reliably in a fast‑paced environment

Experience, Education and Certifications

• Experience working in a Good Manufacturing Practice (GMP) environment - either manufacturing or research - essential. Knowledge of steriles manufacturing preferred.
• Exposure to working in operations, QC or QA within a pharmaceutical environment essential - experience working in radiopharmaceuticals would be ideal.
• Good understanding of advising manufacturing or project teams from a quality and GxP compliance perspective.
• Good understanding of QMS maintenance, risk management, auditing and/or computerized systems.
• Educated to degree level (Chemistry or Life Sciences preferred) or equivalent qualification.
• English: Fluent