Pharmaceutical Specialist
Teva
Haarlem, Netherlands
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!
Your responsibilities
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 etc.
- Knowledge transfer, training of manufacturing personnel or technicians.
Your profile
- 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.
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