Technical Transfer Specialist
Neuraxpharm, Spain
Job Description
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of central nervous system disorders (CNS). We have a direct presence in 19 countries and plan further geographic expansion as part of our strategy to strengthen our position as a European leader in CNS treatments.
With its focus on CNS, Neuraxpharm develops and commercializes established brands, value added medicines, generics, Consumer Healthcare products, medical cannabis and beyond-the-pill-solutions and is continuously striving to offer a wide range of effective, high quality and affordable CNS treatment options in Europe.
Present with our products in more than 50 countries, Neuraxpharm also manufactures pharmaceutical forms and active pharmaceutical ingredients in our own manufacturing sites in Spain. With more than 900 professionals, Neuraxpharm has a unique understanding of the CNS market built over 35 years.
Neuraxpharm is searching for a vacancy: Technical Transfer Manager
Main Missions are:
Evaluation and assessment of production and analytical instruction for:
- Raw materials: excipients and pharmaceuticals active ingredients
- Semi finished: For solids and liquid forms
- Pharmaceutical finished products: For solids and liquid forms.
Definition of production and analysis transfer program for the defined transfers in products, the main topics are:
- Transfer validation strategy
- Analytical Method Transfer / Validation
- Process Validation
- ICH stability guidelines
- GMP Guidelines
- Change Control procedures
- Variation guideline basic understanding
-Write or approve the technical documentation of the Quality Control, Quality assurance and regulatory department in accordance with current quality regulations.
-Provide technical support and to coordinate Quality Control analysts, QA specialist and regulatory specialists towards the execution of all activities of preparation, follow up and achievement of objectives, supervise all the activities and results of the work defined in the transfer program/project. To define actions to address any gap or difficulty faced during the activities.
Requirements
- Experience minimum demonstrable of 1-2 years as technology transfer in Quality Control and quality assurance technician of a pharmaceutical company.
- Extensive knowledge of basic and specific manufacturing and analytical methods for pharmaceutical products.
- Analytical Method Transfer / Validation
- Process Transfer / Validation
- ICH stability guidelines
- GMP Guidelines
- Change Control procedures
- good understanding of the Variation Guideline
- Degree in Pharmacy or Chemistry.
Benefits
- Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
- Economic conditions will be according to the experience and skills provided.
- A motivated and committed environment based on a diverse and inclusive culture.
- A specialized team focused on our core activity: Improving our patients’ lives.