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13 Juil 2017

Temps Plein MPU PS MMC Product and Quality Expert Manager

Wavre

Description de L'emploi

GlaxoSmithKline
Ville: Wavre WBR BE
Scientific university degree (Biologist, Biochemist, Bio-engineer, PhD,..)

– Technical experience in laboratory and/or working experience in

pharmaceutical/biotechnology industry

Preferred qualifications:

– Excellent knowledge of products and manufacturing techniques for vaccines

– Excellent knowledge of quality control technics

– Excellent knowledge of cleaning principles

– Good knowledge of statistical tools

– Good communication skills

– Excellent knowledge of written and oral English (and French)

– Good knowledge of Word, Excel, PowerPoint, Microsoft project, Outlook,

Documentum, SAP (Deviations, change control, data trending),..

– Capability to understand different manufacturing processes so as to critically analyse

and challenge the manufacturing processes

– Capability to interact, communicate and collaborate with the GSK Vaccines network

(TRD, Manufacturing, QA, Local Validation, RA, MSAT, Product Transfer,..)

– Capability to deal remotely with foreign sites and with different cultures

– Capability to manage several projects in parallel

– Technical experience in laboratory (PhD student, research,..)

– 5 years’ experience in a pharmaceutical function related to process development,

process validation or manufacturing activity is an asset

Details:

Job Purpose:

– Owner the product expertise of the quality control expertise and cleaning expertise

For the MPU PS/MMC

– Key Responsibilities:

– Responsible of products for the MPU PS MMC:

– Life cycle project:

– Be the MS LCV representative within GIO

– Provide support in the collect and the analysis of the data for the periodic

quality review

– For a given technical change, provide support to the LCTT leaders by

timely ensuring the preparation of high quality RA document.

– Transfer activities:

– Provide support to the Tech Transfer Leader/coordinator

– Follow-up of the commercial production:

– Shopfloor to train people

– Providing help in the management of critical deviation

– Providing support to the TRA , CPV coordinator

– Providing support to the trend analysis

– Support the PQR exercise

– Participate as leader or member of product / Validation task force

– Shopfloor to understand and explain issue

– Performing analysis of the data (statistics , OE tools)

– Ensuring a close follow-up of the defined actions with the different stakeholder

– In charge of the Quality control expertise for the MPU products

– By supporting complex deviations linked to QC issue

– Understanding of all QC testing performed on MPU products

– Being able to train MPU people on the QC testing principle

– In charge of the cleaning management by:

– Defining the cleaning strategy / validation

– Support the floor on problem solving

– Ensuring the interim report

Maintain all those topics in inspection readiness level and provide the necessary

support in any internal or external audit in addition to providing expert input to and

review of regulatory documentation

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.

Our department:

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 more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.

The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.

Our Company:

GSK is one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK Vaccines is one of the world’s leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world’s countries.

For further information, please visit www.gsk.com.

Contact information:

You may apply for this position online by selecting the Apply now button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/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 employment businesses/agencies in respect of the vacancies posted on this site.

villes : Wavre. Les catégories d'emploi : Engineering - Technique. Types d'emplois : Temps Plein.

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