Syntese - A Ferring Company
Are you a quality-minded, driven Process Supporter, and do you want to play a key role in safeguarding quality by driving optimization and development of Syntese’s production?
Syntese is looking for an experienced Process Supporter to join their manufacturing site in Hvidovre. The company is among the world’s largest manufacturers of Mesalazine, an Active Pharmaceutical Ingredient (API), essential in the treatment of Inflammatory Bowel Diseases. As Syntese is a fully integrated manufacturing company within Ferring Pharmaceuticals, you will be a major contributor in enhancing quality and ensuring operational excellence in the handling of all Production Support related tasks and responsibilities.
Production support and optimization projects in a cross-functional context
As Process Supporter, you will join Manufacturing Support Science & Technology (MSST). MSST is a cross-functional department consisting of both production support and R&D resources. Currently, the department is comprised of five Process Supporters, a Laboratory Technician and four Development Chemists working closely together.
You will be responsible for handling production support activities in a correct and timely manner as well as participating on various optimization and production development projects. You will review batch documentation, handle deviations in addition to defining and reviewing corrective and preventive actions. Furthermore, you will manage changes through the change request process and validate production processes.
As Syntese has a focus on further strengthening our quality management system, your previous experience in managing manufacturing and process challenges will be highly valued and you will experience a great degree of maneuverability and independence in your job. If relevant, you will also get the chance to work closely together with Development Chemists and carry out investigations in the analytical- and synthesis laboratories or pilot plant. You will have a variety of stakeholders, including Manufacturing, Quality and Technical departments as well as external suppliers and consultants.
Your tasks will include, but not be limited to:
- Review batch documentation
- Create, investigate, and complete deviations
- Define and review Corrective and Preventive Actions (CAPA)
- Manage changes through Change Requests
- Develop and update GMP documentation
- Do project work in all project phases
- Validate production processes
- Do investigations in analytical- and synthesis laboratories or pilot plant
Experience with production support, organic chemistry and/or validation of processes
You hold an academic degree in Chemistry, Chemical Engineering, Pharmacy or equivalent. You have solid GMP knowledge and at least a couple of years’ experience in life science. You know about and have experience with at least two of the following areas: Handling deviations in API and/or pharmaceutical production, knowledge of production equipment, organic chemistry, evaluation of analytical results, validation of processes or statistical analysis.
You have excellent communication skills, including experience in developing written documentation and arguments. Furthermore, you have flair for IT and a desire to work with process control systems. Your working style is determined, structured, and independent. As the work is GxP related, correct and timely documentation is an integrated part of your approach to solving a task. As a person, you are friendly and forthcoming together with being flexible and an active contributor to keeping spirits high.
At Syntese, you will experience great space for action and the possibility to work independently in addition to having a high impact in the organisation due to Syntese’s empowering culture and very short decision paths. Working at Syntese, you will join Ferring Pharmaceuticals Group which is committed to supporting all employees in their career development and to ensuring all their team members receive the right level of support and progression. Ferring employs over 6,000 people across 56 countries and the diversity of their team brings exciting ideas and innovation. By working together, they can apply new science to unmet needs to help people live better lives.
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Research Manager, Pernille Hemmingsen or Research Consultant, Emilie Tondering at +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.
Syntese A/S is part of Ferring Pharmaceuticals, a research-driven, specialty biopharmaceutical leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Syntese was founded in the early 1980s when a Ferring Group team in the Synthesis department invented the 5-ASA purification process that was to become the cornerstone of their business. Today, Syntese manufactures Mesalazine, an Active Pharmaceutical Ingredient (API) used in treating Inflammatory Bowel Diseases. Syntese is renowned worldwide for stable Mesalazine of exceptional quality. The company has been growing steadily during its lifespan and is now among the world’s biggest manufacturers of Mesalazine – and still the only company that is dedicated only to Mesalazine and nothing but. Syntese’s Mesalazine is registered in more than 90 countries, including the EU, the US, Canada, Japan, Australia, and Russia.
Deadline: As soon as possible