Specialist, Complaints/TTS
-University degree in Sciences (Bio Engineer, Biologist, Chemist,...)
-Biological manufacturing processes knowledge is an asset
-Fluent English and French, spoken and written
-At least 5 years within the Pharmaceutical Industry
See Basics Qualifications
GlaxoSmithKline Biologicals (GSK Biologicals), the vaccine division of the GSK Group, is a global vaccine research, development and production company, at the cutting edge of innovation in the fight against the most deadly infections and diseases. Headquartered in Belgium, GSK Biologicals employs over 11,000 people worldwide, of which 7,000 in its three Belgian sites: Rixensart, Wavre and Gembloux. GSK Biologicals’ global production network is in the midst of becoming the largest in the entire vaccines industry; 15 production sites strategically positioned around the world manufacture, formulate, fill, pack, check and deliver over a billion doses of about 30 different vaccines.
Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.
As the name suggests, it operates in a multi-national context across 15 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.
The department itself is divided into operating units that focus on various aspects of the manufacturing and supply process. These include Supply Chain Management, Global Quality Assurance, Technical Services, and Industrialisation, which oversees the transfer of production from R&D levels to a commercial scale.
Applicants should have a scientific or engineering university degree, along with some pharma or bio-pharma industry experience. In return, you'll have the opportunity to use your strong organisational skills in a challenging and complex project-driven environment.
-Raises and maintains the status of quality in the organisation and enables a company to promote itself as one that provides quality goods and services.
-Involves Total Quality Management (TQM) programmes and the development of standard procedures in accordance with GSK standards and cGMP Regulations.
RE01 Technical complaints
-Collects technical complaints data on all marketed products
Implements and manages technical complaints processes and databases
-Performs data trending with rapid identification and analysis of recurrent technical issues, to define quality profiles of all products and drive patient risk management
-Delivers high quality product quality data and analysis to
internal and external customers throughout the product life cycle
-RE02 Technical complaints
-Provides internal and external parties with technical
information on company products
-Collects the information requirements and ensures a timely
treatment of technical enquiries and requests
-Optimises the filing and acces of the system (codification,
indexation, etc) as well as documentation techniques (may include intranet and/or extranet developments)
-Provides limited training and advises the Bio manufacturing sites
-Ensures complaints are recorded, investigated adequately and answered in a timely manner
-Communicates monthly reports describing trends, root causes and CAPA’s of technical complaints to the management of all GSK Bio sites
-Coordinates investigations as a team leader in case of serious incidents
-Organises and leads interdepartmental meetings in case of serious incidents (PIRC, BPDR committee);
-Informs, communicates on recurrent and serious events through meetings such as Site Quality council, PIRC, BPDR committee, Technical committee (Comité C);
-Responds to external (GSK commercial units) and internal
(Manufacturing sites, BCSP, ...) clients' needs through explanation and clarification of issues and reporting (per building, site, product, country, topic);
-Prepares and presents major technical complaints and trend
analysis to Quality Councils
-Maintains and updates GSOP’s regarding complaints, recalls and counterfeiting
Our Offer:
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Contact information:
You may apply for this position online by selecting the Apply now button.
GSK only accepts spontaneous individual applications. GSK does not accept referrals from recruitment companies and/or interim employment agencies in respect to the vacancies posted on this site. All recruitment companies/agencies are required to and, indeed, are invited to contact the Head of "recruitment” (Human Resources department) to obtain prior written authorization before referring any candidates to GSK. In the absence of such a written authorization, any actions undertaken by the recruitment company/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by recruitment companies/agencies in respect to the vacancies posted on this site.
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