Planning & Scheduling Specialist

• Own and coordinate deviation records, supporting timely investigations and effective CAPA implementation
• Support and monitor change control activities to ensure compliant and efficient implementation of process and system changes
• Create, maintain and improve Standard Operating Procedures (SOPs) and Good Manufacturing Process (GMP) documentation that support robust and inspection-ready operations
• Execute calibration, validation and qualification activities for equipment and systems in accordance with approved standards and procedures
• Investigate technical issues, perform root‑cause analyses and help implement sustainable corrective actions
• Perform quality risk assessments to support sound decision‑making and maintain a high level of compliance
• Partner with cross‑functional stakeholders to support audits, inspections and ongoing readiness activities
• Contribute to improvement projects that enhance compliance, system performance and operational efficiency
• Support Environmental Health & Safety activities, including Management of Change, where applicable
• Ensure accurate, complete and timely technical and quality documentation across assigned responsibilities

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Pharmacy, or a related field preferred
• Several years of experience in a GMP‑regulated pharmaceutical, biotechnology, or clinical manufacturing environment
• Hands‑on experience in deviation management, change control, CAPA management and SOP/documentation processes
• Practical knowledge of calibration, validation and qualification activities for equipment and systems
• Strong technical problem‑solving skills with the ability to work independently and make sound decisions within established procedures
• Solid understanding of GMP requirements and quality risk management principles
• Fluent in English, written and spoken; additional language skills are an advantage
• Comfortable managing multiple priorities in a fast‑paced and regulated environment
• Experience with systems such as SAP, Pro Cal, eVal, DeltaV, Veeva Vault, MEDS, or eShop Floor is considered an advantage.

Demonstrates expertise in deviation management, change control, and CAPA implementation within GMP‑regulated environments, ensuring compliance and operational efficiency. Proficient in creating and maintaining SOPs and quality documentation while supporting audits and inspections.

• Deviation Management
• Change Control
• CAPA Management
• GMP Compliance
• Quality Risk Management

• Deviation Management
• Change Control
• CAPA Management
• Calibration Activities
• Validation Activities
• Qualification Activities
• Quality Risk Assessment
• Technical Problem‑Solving
• SOP Documentation
• GMP Requirements

• Strong Decision‑Making
• Ability to Work Independently
• Comfortable Managing Multiple Priorities

• Life Sciences
• Pharmaceutical
• Biotechnology
• Clinical Manufacturing
• Environmental Health & Safety

• SAP
• Pro Cal
• EVal
• DeltaV
• Veeva Vault
• MEDS
• EShop Floor