Teva Pharmaceutical Specialist 

Netherlands, North Holland, Haarlem 

199828876

Responsible for pharmaceutical and quality aspects within production, including:• 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.• 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.

• Minimum of a bachelor degree in Pharmacy, Pharmaceutical technology, Bio-Chemistry or any related field
• Knowledge of (aseptic) pharmaceutical production processes
• Experience in working with Quality Systems / GMP and experience in working with production control systems would be an advantage
• Act and behave as the liaison between Quality and Manufacturing departments.
• Good communication and consulting skills
• Fluent English knowledge
• Dutch language knowledge would be an advantage
• Strong analytical, reporting and planning skills
• Resistant to a hectic production environment
• Training and knowledge transfer skills

Associate Director Production

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