Process Supporter (Pharmaceutical, Osted)

Job summary

The Process Supporter is responsible for enhancing production operations by managing deviations, resolving issues, and ensuring compliance through proper documentation. This role involves handling non-conformances, initiating corrective actions, and maintaining training materials to align with regulatory requirements.

Qualifications

• Relevant background in pharmacy, technical training, or process support.
• Minimum of 3 years of experience in a GMP regulated production environment, particularly in Pharma or Medical Devices.
• Familiarity with non-conformance (NC) and corrective and preventive actions (CAPA).

Responsibilities

• Oversee deviation management and assist in CAPA documentation.
• Develop and update Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Create and maintain training materials and ensure compliance with training requirements.
• Implement training for new or updated processes and maintain training records in the quality management system.
• Collaborate with managers to identify training needs and design training programs.
• Participate in NC and CAPA work related to training in conjunction with Quality Assurance.

Skills

• Knowledge of TrackWise and Documentum is advantageous.
• Familiarity with ERP systems, preferably SAP.
• Strong organizational skills and ability to manage multiple tasks.
• Effective problem-solving skills and a structured approach to improving systems.
• Strong communication skills and ability to work collaboratively.

Education

• Relevant technical or production-related training in a regulated environment.

Tools

• TrackWise, Documentum, ERP systems (preferably SAP).