The Role

• Carry out functions relevant to the Quality (Good Manufacturing Practice) objectives and policies of Catalent Limited.
• Provide Quality Assurance expertise to ensure Quality processes operate to acceptable standards.
• Manage the control, tracking, and timely flow of Good Manufacturing Practice documentation to support production schedules.
• Review and approve material specifications, ensuring compliance with pharmacopoeia, Good Manufacturing Practice, and client requirements.
• Review and approve incoming, intermediate, and finished materials for release.
• Review and approve randomisations, Good Manufacturing Practice documentation, and packaging batch records for accuracy and compliance.
• Liaise with cross-functional teams to resolve quality issues and maintain delivery timelines.
• Support Quality Management System activities, including timely closure of TrackWise records.
• Conduct internal audits, monitor trends, and support continuous improvement initiatives.
• Host client audits and coordinate responses to audit observations and corrective actions.
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The Candidate

Minimum Requirements

• Bachelor of Science in a relevant scientific topic or appropriate Quality experience in a pharmaceutical environment.
• Proven number of Quality experience in a Pharmaceutical or Clinical Trials setting.
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Preferred Skills & Background

• Excellent verbal and written communication skills.
• High level of concentration and attention to detail.
• Ability to prioritise daily and weekly workload.
• Ability to work independently.
• Strong analytical and problem-solving skills.
• Ability to be decisive on material and product quality issues to ensure compliance.
• Knowledge and experience in environmental monitoring is desirable.
• Comfortable in a client-facing setting.
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