Quality Assurance Officer (Ref:CBS16)

As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal products. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.
We are currently looking to recruit a Quality Assurance Officer to the Quality Assurance team. This role is a permanent position.
The successful candidate will be required to work closely with the Operations teams, project managers as well as with other functions within the organisation.

The main responsibilities will be to:
* Review and approve documentation related to manufacturing and analysis (batch manufacturing records, process descriptions, analytical methods etc)
* Participate as a QA representative on cross-functional project teams
* Assess and approve standard operating procedures, validation documentation, reports and other relevant quality-related documents
* Assess and approve deviations and investigation reports to ensure that root causes have been identified and appropriate actions are implemented
* Perform audits of suppliers
* Participate in internal and external inspections
* Work with teams to identify areas for continuous improvement of the quality system and provide quality guidance

Qualifications:
* University degree in scientific subject
* Specialized in microbiology and clean room manufacturing
* Knowledge and experience of working in a quality assurance role
* In-depth understanding of Good Manufacturing Practises. Experience in interpreting and applying regulations and guidelines
* Experience from working in the pharmaceutical manufacturing industry (preferably with biologics)
* Good communication, organizational and interpersonal skills
* Ability to work independently
* Quality orientated
* Fluent in Swedish





The position will be based at the Södertälje site.
Applications should be sent in writing stating the appropriate reference number with full C.V. to:
Maria Krook, Cobra Biologics, email; maria.krook@cobrabio.com

CLOSING DATE: 15 January 2014, applications will be reviewed on a continuous basis as received