Temps Plein QA Specialist, Clinical Manufacturing & Supply Quality
Description de L'emploi
Ville: Rixensart WBR BE
– Diploma: Scientific university degree (Pharmacist, Engineer or equivalent)
– Professional Experience : Minimum 5 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
– Knowledge: Very good knowledge of English, GMP regulated environment, clinical trial and product development
– Use of Pack Office (Word, Excel, PowerPoint)
– Well organized– rigorous
– Analytical and synthesis ability
– Initiative Taken
– Sense of observation and critical thinking
– Good relationship : working within pluridisciplinary teams, sharing knowledge, listen to others
– Leadership capability to manage people and costs
– Ability to adapt communication depending on audience
In the respect of Quality, Safety and GSK standards and cGMP regulations, the QA Specialist :
– Develops, assures and maintains the quality of the product and processes
− Standard procedures
− Quality audits/review
− Key Performance Indicators (KPIs)
− Step quality decision
– Organizes and takes responsibility for Quality Assurance in all activities related to clinical
vaccines for CM&S TRD department (Drug Substance)
– Approves master production records and procedures for production
– Develops strong partnership with transfer and validation team to ensure that CPP and CQA
are adequately integrated in the operational procedures or master batch record and in line with PVDS requirements.
– Ensures all GMP productions are in line with product development evaluations and regulatory
– Ensures batches of the intermediate product related to the area of responsibility are released in a timely manner and in line with the product specification file
– Ensures deviations, complaints, change controls, OOS investigation, maintenance and calibration plans are reviewed and handled in a timely manner
– Ensures critical topics and risks are adequately managed and timely escalated to higher
– Represents QA in all operational meetings related to the area of responsibility (staff meetings, deviation, CAPA, change control follow-up meetings,…). Responds to client requests in non-standard situations, investigating all the facts
– Performs internal audits
– Contributes to local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirements
– Understands and manages complex technical/production problems and evaluates their potential impact on product quality.
– Compiles quality reviews. Understands key business/scientific issues in own area and takes them into account in work processes.
– Listens carefully, presents information clearly; makes technical information
– Assures regulatory inspection readiness and provides QA expertise to act as a key spokesperson during external regulatory inspection. Ensures CAPA follow-up.
Safety / Quality
– Put in place the necessary actions to ensure the safety of staff
– Identifies improvements in terms of EHS
– Respects and ensures the wearing of personal protective equipment ( EPI)
– Manages deviations and CAPA related to the area of responsibility. Generates possible solutions, assesses each using standard procedures and makes a sound decision.
– Participates to the creation and review of Standard Operating Procedures
– Trains production and QA teams to new procedures or GMP refresh
– Leads meetings to improve practices and compliance level of the quality system with regulatory, GSK Corporate and SME.
– Is up-to-date on internal/external business issues and developments in own area and uses them to set direction and resolve problems for own team.
– Leads, trains, coaches, develops and motivates the team towards the pursuit of operationnal excellence
– Proposes and follows annual objectives for the team. Prioritises and organises own work to deliver to short-term deadlines. Measures the effective performance.
– Contributes to the cohesion and group dynamics.
– Transfers all relevant technical knowledge to the team
– Ensures transfer of information between the different members of the team
– Participates to the organization of the department
– Ensures Quality Oversights on the shopfloor (50%) to transfer practical information, knowledge and improvement tracks.
– Maintains a social climate within the team
– Works to control costs related to own work. Controls own capacity managment
– Ensures succession is in place for key roles in the network to minimize operational risk
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.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
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.
You may apply for this position online by selecting the Apply now button.
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