Temps Plein QA Specialist – SAP Process and Data Management
Description de L'emploi
Ville: Wavre WBR BE
– Education : Scientific university degree (Pharmacist, Engineer or equivalent) or equivalent experience acquired through professional experience.
– Experience :
o minimum 5 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
o Experience on Process improvement is a strong asset
– Knowledge :
o very good knowledge of English (spoken, written and read)
o Knowledge of GMP regulated environment
– Technical and system/process specialist giving QA support to the LBPM (Local Business Process Management – SAP) and Data Management activities under the responsibility of Belgium Site Management, Belgium Engineering and Maintenance (BeEM) and Logistic and Incoming Materials (LIM) through Wavre and Rixensart sites.
– Being part of the team that will cover Quality Assurance activities for :
o Data Integrity Program for Belgium MPU’s and SPU’s.
o Data Integrity Action Plans for Belgium Site Management, Belgium Engineering & Maintenance, Logistic & Incoming Materials
o Paper Document Archiving Process for Belgium Site MPU’s and SPU’s.
o All business processes (SAP) applicable on the Belgian site, from R&D to Belgian Operations
– This job includes ability to evaluate potential consequences or risks identified on patient safety and regulatory aspects (escalation and communication).
– Proactively identify potential quality processes risks and manage these risks through the dedicated risk register.
– Lead and coordinate a continuous improvement and compliance program to ensure processes are performing optimally both in terms of efficiency and compliance to department-specific and GSK standard requirements
– Review, correct and improve Standard Operating Procedures against their purpose and scope. Assure readability and alignment against reference standards (Policies & processes).
– Be the preferred front line contact person during inspection for the subject of expertise as well as for all operational aspects belonging to the area of responsibility
– Masters the key QA activities related to production, QC, maintenance and calibration, warehouse, CSV, validation, project activities in his/her area of responsibility
– Ensures deviations, complaints, change controls, OOS investigation, maintenance and calibration plans are reviewed and handled in a timely manner
– Represents QA (decision responsibility) in all meetings related to the area of responsibility (staff meetings, deviation, CAPA, RPC follow-up meetings, …)
– Ensures critical topics are adequately escalated to higher management
– Acts as QMS subject matter expert (= knowledgeable of the QMS standard related to the area of expertise, ensure all requirements of the standards are cascaded in SOP’s, accountable for gap analysis and related action plans)
– Performs internal and act as external supplier audits
– Understands technical/production complex problems and evaluates potential impact on product quality
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.
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.
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