QA/QC Specialist

- 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.) and 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 Pharma Corporate Quality Manual, Policies and
local SOPs
- Ensures that all sample logistics (eg 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 (ie 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

(eg number and condition of samples, etc.)
- Provides expert advice to customers (eg 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 (eg
ICH, FDA, etc.) and guidelines (eg Quality Manual, NovStyle templates, 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.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.