We have a new opportunity for a quality assurance specialist to overview all activities concerning stabilities of assigned Biotech drug products.
To design, interpret and report stability studies for assigned Biotech drug products,
To comply with current GMP and regulatory requirements, requests from Health Authorities, general (ICH, FDA, etc.) 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
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 (TechOps), taking into account
current regulatory requirements, requests from Health Authorities, general guidelines (e.g.
ICH, FDA, etc.) Supports preparation for internal and external inspections 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.
Prior experience in quality assurance and stability testing methodology
Fluency in English language, German is an advantage
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.