Sr. Specialist

About the role

The Sr. Specialist will ensure that production activities in the J‑II sterile value stream comply with safety, quality, and regulatory standards. You will drive continuous improvement, manage risk assessments, and support investigations to maintain a safe and compliant manufacturing environment.

Key responsibilities

• Monitor and enforce EHS requirements, ensuring proper PPE use and safe work conditions.
• Conduct and document departmental safety risk assessments, implementing mitigation actions.
• Lead continuous‑improvement initiatives and benchmark against other value streams.
• Ensure production follows cGMP/GxP policies, contamination control strategies, and quality risk assessments.
• Manage QMS activities such as CAPA implementation, change control, and deviation investigations.
• Report safety incidents and support the Sterile Value Stream Manager with safety‑related projects.
• Track and report safety and quality KPIs to meet annual objectives.

Required profile

• Proven experience in pharmaceutical or sterile manufacturing environments.
• Strong knowledge of local regulatory, EHS, cGMP, and GxP requirements.
• Ability to lead risk assessments, investigations, and continuous‑improvement projects.
• Excellent communication and teamwork skills.

Required skills

• cGMP/GxP compliance
• CAPA management
• Risk assessment and mitigation
• Contamination control strategy (CCS)

What we offer

• Opportunity to contribute to a leading pharmaceutical company’s safety and quality culture.
• Professional development in a collaborative, innovative environment.