Description
On behalf of my client, one of the largest pharmaceutical companies in the world with headquarters in Basel, Switzerland I am currently recruiting for a:Stability studies specialist 100% m/f
Job Purpose:
- To overview all activities concerning stabilities of assigned Biotech drug products.
- To design, interpret and report stability studies for assigned Biotech drug products, to satisfy current GMP and regulatory requirements, requests from Health Authorities, general (ICH, FDA, etc.) guidelines.
- To ensure the compliant, efficient and timely handling and management of stability samples of assigned Biotech drug products and associated documentation.
- To ensure that all aspects of the operational business comply with cGMP and HSE legal and regulatory requirements and with the Corporate Quality Manual, Policies and local SOPs
Main Tasks:
- Ensures that all sample logistics (e.g. transportation, receipt, labelling, storage, disposal), are performed and documented according to the local Quality system and SOPs, HSE and ecological standards and requirements
- Manages the administration of stability programs in LIMS (i.e. timely and correct preparation of programs as well as their changes) taking into consideration regulatory stability requirements and information in the approved stability protocols
- Ensures samples are taken according to the relevant stability program, that samples are stored in the stability chambers promptly upon receipt and all samples and associated documentation are available the laboratories within the required timelines
- Communicates with the manufacturing sites in case of any deviations related to the samples (e.g. number and condition of samples, etc.)
- Provides expert advice to customers (e.g. regulatory affairs) on all stability related topics, such as deviations in product storage, transportation, etc.
- Compiles and interprets stability data and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories.
- As part of the preparation of stability reports monitors stability data and communicates any adverse trends to management and study sponsor.
- Timely prepares and reviews stability protocols and reports taking into account current regulatory requirements, requests from Health Authorities, general guidelines (e.g. ICH, FDA, etc.)
- Supports preparation for internal and external inspections at PharmOps CH according to the Quality Manual and answers questions during inspections.
- Ensures implementation of associated corrective and preventive actions.
- Supports external inspections at customer sites on stability matters, related to assigned product responsibility.
- Supports implementation of associated corrective and preventive actions.
- Timely prepares evaluation reports of stability data in support of Annual Product Reviews, Product Quality Reviews, etc.
Candidate Profile:
- University degree in Pharmacy or Chemistry or equivalent
- Experience in ensuring regulatory compliance of stability studies
- Good GMP knowledge and stability guidelines (ICH Q1, etc.)
- Sound knowledge of current GMP and regulatory requirements, general guidelines (ICH, FDA, etc.)
About me:
I am a specialized recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word format including your hourly rate expectation for immediate consideration.
For any additional information's you can reach me on or at