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Quality Assurance Senior Specialist Liège Belgium,  


Posted on : 01 December 2016

Project Description

In order to face the development of its activities, ASIT biotech is currently seeking a Quality Assurance Senior Specialist to support of the Quality Assurance/Regulatory Affairs activities of ASIT biotech in the development of new ASIT+TM technology based allergy immunotherapy products. Main responsibilities will include Establish policies, procedures and quality standards (working with operating staff to establish technical procedures) Assure compliance with quality and industry regulatory requirements Organize in-process control and ensure proper documentation is in place Develop and monitor quality indicators Organize, execute and document internal audits and develop, recommend and monitor appropriate corrective actions Coordinate and support on-site audits/inspection and perform audit of subcontractors Determine training needs and establish training plan Review and approve the batch records of R&D department as well as study reports that will be incorporated into regulatory submissions to assure scientific rigor and accuracy Release the batches of drug substance manufactured by contract manufacturing organizations and ensure the timely release of the batches of drug product Coordinate investigations required following deviation and out-of-specification results Is responsible for document management systems Requirements and competencies Scientific degree in life sciences or pharmacy Minimum 5 years of experience in the field of Quality Assurance Aptitude for problem analysis and solving Attention to detail Decision making Acting as a catalyst for change and improvement in performance/quality Team player, strong interpersonal skills Strong organizational and communication skills (oral and written) Fluent French and English Demonstrated ability to deliver results to the appropriate quality and timeline We offer A company with a very high growth potential, Interactions with a very competent team and motivating environment, Involvement in the development of innovative products to satisfy a real unmet medical need, Attractive salary and benefit package Position Location: Li?ge Belgium Applicants should send their CV to: Mr. Albert Vicaire (albert.vicaire@biotech.be) with reference to Quality Assurance Senior Specialist Application . About ASIT biotech ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+TM technology platform, ASIT biotech is currently the only developer of AIT product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotechs product pipeline entails two novel ASIT+ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+TM and house dust mite: hdm-ASIT+TM), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+ platform is flexible and would be applicable across a range of allergies. gp-ASIT+TM, our product candidate for the treatment of grass pollen rhinitis consists of a mixture of natural allergen fragments obtained from a purified specific proteinic extract from Lolium perenne pollen. In contrast to the synthetized peptides, the natural peptides (70% of the fragments ranging from 1,000

Locations

Liège, Belgium

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