Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.
Johnson & Johnson
BE - Analyst 2, Quality Assurance
Job is closed
Posted
Sep 27, 2022
Job ID:
JJJP00012274
Location
Geel
Hours/week
40 hrs/week
Timeline
9 months
Starts: Oct 3, 2022
Ends: Jun 30, 2023
Payrate range
Unknown
Application Deadline: Oct 3, 2022 12:00 PM
Quality Support Engineer QA ? QS&E
Assuring high Quality Standards and cGMP Compliance during: - Projects concerning Qualification of (process) equipment, utilities and facilities & automation systems ? Final responsibility for release of these systems regarding cGMP compliance - Change Controls for equipment, utilities & facilities, automation systems. - Review and approval of base load activities (SOP?s, trend reports, ?) - Deviation Management This includes: · Represent quality, as Quality SME, in different forums, team meetings & projects · Ensure quality oversight of the operational and project activities by documented QA approval of GMP documentation, periodic system quality reviews and by active participation in project teams including: o Review and approval of Qualification Documents (URS/SRS, Impact Assessments, PQP, DQ IQ OQ & PQ protocols & reports, QSR o Review and approval of cleaning test/monitoring/verification & validation protocols and reports o Review and approval of Change Controls in CC Management System o Review and approval of procedures, work instructions, forms o Review and approval of SAP Master Data o Review and approval of periodic monitoring and trend reports o Review and approval of Periodic System Quality Review documents (PSQR) o Ensure that deviations/complaints are timely and properly investigated such that the internal and external customer and product expectations are met o Support in-depth investigations by providing technical, quality and compliance expertisex
Define adequate CAPA?s for Quality Investigations regarding equipment, utilities and facilities, automation and cleaning with potential quality impact o Follow up CAPA execution and record closure o Ensure that deviations/complaints with potential impact on patients and/or product supply are properly escalated
Understanding of pharmaceutical product development, qualification, validation, manufacturing, packaging, labelling, testing, release, storage and distribution processes · Knowledge of task related cGMP regulations and guidelines · Technical background and base knowledge of chemical/pharmaceutical process equipment · Strong analytical thinking, risk assessment and decision-making skills · Strong quality mindset · Strong communicator · Assertive, ability to convince and motivate · Integer and stress proof
Degree
Master?s Degree in scientific/technical discipline prefered
Languages
Dutch and English (spoken as well as written)
Assuring high Quality Standards and cGMP Compliance during: - Projects concerning Qualification of (process) equipment, utilities and facilities & automation systems ? Final responsibility for release of these systems regarding cGMP compliance - Change Controls for equipment, utilities & facilities, automation systems. - Review and approval of base load activities (SOP?s, trend reports, ?) - Deviation Management This includes: · Represent quality, as Quality SME, in different forums, team meetings & projects · Ensure quality oversight of the operational and project activities by documented QA approval of GMP documentation, periodic system quality reviews and by active participation in project teams including: o Review and approval of Qualification Documents (URS/SRS, Impact Assessments, PQP, DQ IQ OQ & PQ protocols & reports, QSR o Review and approval of cleaning test/monitoring/verification & validation protocols and reports o Review and approval of Change Controls in CC Management System o Review and approval of procedures, work instructions, forms o Review and approval of SAP Master Data o Review and approval of periodic monitoring and trend reports o Review and approval of Periodic System Quality Review documents (PSQR) o Ensure that deviations/complaints are timely and properly investigated such that the internal and external customer and product expectations are met o Support in-depth investigations by providing technical, quality and compliance expertisex
Define adequate CAPA?s for Quality Investigations regarding equipment, utilities and facilities, automation and cleaning with potential quality impact o Follow up CAPA execution and record closure o Ensure that deviations/complaints with potential impact on patients and/or product supply are properly escalated
Understanding of pharmaceutical product development, qualification, validation, manufacturing, packaging, labelling, testing, release, storage and distribution processes · Knowledge of task related cGMP regulations and guidelines · Technical background and base knowledge of chemical/pharmaceutical process equipment · Strong analytical thinking, risk assessment and decision-making skills · Strong quality mindset · Strong communicator · Assertive, ability to convince and motivate · Integer and stress proof
Degree
Master?s Degree in scientific/technical discipline prefered
Languages
Dutch and English (spoken as well as written)
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