We are seeking an experienced Production Expert III to support pharmaceutical manufacturing operations within a highly regulated production environment. This is an excellent opportunity for a quality-focused professional to play a key role in ensuring GMP compliance, driving continuous improvement initiatives, and supporting operational excellence across production activities.

Verantwoordelijkheden

• Provide quality oversight and support for bulk manufacturing and packaging activities.
• Support investigations relating to deviations and production-related quality issues.
• Assess production impacts and support decision-making when deviations occur.
• Recommend and implement improvements to manufacturing processes and product quality.
• Monitor production performance and identify opportunities for continuous improvement.
• Conduct investigations into deviations, complaints, and quality events.
• Lead root cause analyses and develop effective CAPAs.
• Support internal and external audits and compliance-related activities.
• Contribute to health, safety, environmental, and product quality initiatives.
• Review SOPs, validation protocols, batch records, and associated GMP documentation.
• Support change controls, CAPAs, validation activities, and quality projects.
• Ensure documentation meets regulatory and company quality standards.
• Deliver training and facilitate knowledge sharing across teams.
• Work closely with production leadership, operators, technical specialists, QA professionals, project teams, and Qualified Persons (QPs).
• Participate in department meetings and improvement initiatives.
• Provide expert guidance on quality-related matters across the business unit.

Vereisten

• Master's degree (or equivalent academic level) in Pharmacy, Chemical Engineering, Life Sciences, or a related discipline.
• Experience working within pharmaceutical manufacturing environments.

Gewenste Vaardigheden

• Strong knowledge of GMP and quality assurance systems.
• Experience investigating deviations, performing root cause analysis, and managing CAPAs.
• Excellent analytical, communication, and reporting skills.
• Fluent English communication skills, both written and verbal.
• Experience within aseptic manufacturing environments.
• Knowledge of pharmaceutical production control systems.
• Experience supporting audits, inspections, and compliance activities.
• Previous involvement in quality improvement or operational excellence projects.

We are committed to creating an inclusive workplace where everyone can thrive. We welcome applications from all qualified individuals and encourage candidates from underrepresented backgrounds to apply. If you require any reasonable adjustments during the recruitment process, support will be available to help ensure an accessible and positive candidate experience.