The opportunity
Are you an ambitious professional who is already familiar with pharmaceutical production processes? Are you someone who enjoys asking questions? Do you find it important to understand the way things work? Get ready for a new challenge in the Pharma industry and join the investigation and improvement team, as a Pharmaceutical Specialist!
What is the goal of the Investigation and Improvement team? They are the brain of the company! The key aim of the team is to investigate any issues in production and find the root cause. They draw up, initiate and execute improvement proposals in response to production deviations. They assess or decide whether production activities should be stopped or adapted. Be part of this dynamic team and take your career to the next level! Work between production and the quality department and participate in various projects to improve quality aspects. In this dynamic position every day looks different. If you are creative, likes to be busy and always enjoys something new, then this position is for you!
How you’ll spend your day
Responsible for pharmaceutical and quality aspects within production, including:
Ensure the improvement, support, testing and control of the activities related to pharmaceutical manufacturing process (bulk production and packaging):
• Support the production department in case of deviations and quality issues.
• Assess or decide whether production activities should be stopped or adapted due to a deviation.
• Make proposals to improve manufacturing methods and products, and to implement developments in manufacturing technology.
Provide substantive and technical support to the Business Unit with regard to quality issues and improvement processes:
• Monitoring and reporting on (deviations from) the manufacturing processes.
• Investigate and document observed deviations and complaints.
• Conduct and document root cause investigations and CAPAs.
• Drawing up, initiating and executing improvement proposals in response to production deviations, (internal and external) audit observations or as part of continuous improvement.
• Making recommendations for working conditions, (product) safety and the environment.
• Participate in various projects to improve quality aspects.
• Support with Compliance investigations and Audit responses.
Implement and maintain the corporate quality and GMP instructions and ensure adequate protocolling:
• Reviewing SOPs, manufacturing and validation protocols, Master Batch Records (MBRs)
• Prepare and review trend reports on manufacturing processes
• Participate / contribute to projects, changes, CAPAs, root-cause investigations etc.
• Knowledge transfer, training of manufacturing personnel or technicians.
Participate in the Tier structures of the Business Units.
Important: Person will sometimes work on-call.
