QA Officer Drug Substance
Solliciteren
Plaats
BrusselsBelgië
België
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2026-03-07Online to:
2026-05-06EUR 20.00 HOUR
QA Officer Drug Substance
- Jefferson Wells Belgium
- België
- 9 uren geleden
QA Officer Drug Substance
Contracting – Brabant Wallon
Your responsibilities: BACK-UP FUNCTION The position can act as back-up for his direct colleagues after appropriate training
OPERATIONAL QA ROLE Assure that intermediates and active pharmaceuticals products get produced and released in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH) Follow up of product related: change control, failure investigation, deviations, CAPA and action plans, qualification of dedicated equipment (protocols and reports) Review of batch record from intermediates to drug substance Batch disposition of chemical intermediates (DS manufacturing) Review of master batch records and specifications
CONTINUOUS IMPROVEMENT Support the Pharma Manufacturing (BPM) Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operations Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the site. Using a Risk Based Approach, ensure that all BPM Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures hereby considering objectives, plans and projects Promote quality and operational excellence and cultivate “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the BPM and related supporting services Ensure general cGMP training of internal customers Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements Ensure communication of compliance status and issues to appropriate levels of the organization Ensure a relevant cGMP level regarding subcontractors used to support routine operations for BPM and related supporting services Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections
Your profile: Min 3 years experience in Quality Assurance in a regulated pharmaceutical environment or other life science or health related field Experience with Chemical/ pharmaceutical production, development and /or regulatory requirements, including knowledge production best practices in pharmaceutical industry Experience with Quality Management System Ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision Excellent team player attitude with excellent interpersonal relationship and communication skills Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings Fluent in French and English
Our offer ? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, lena.palmeri@jeffersonwells.be
Contracting – Brabant Wallon
Your responsibilities: BACK-UP FUNCTION The position can act as back-up for his direct colleagues after appropriate training
OPERATIONAL QA ROLE Assure that intermediates and active pharmaceuticals products get produced and released in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH) Follow up of product related: change control, failure investigation, deviations, CAPA and action plans, qualification of dedicated equipment (protocols and reports) Review of batch record from intermediates to drug substance Batch disposition of chemical intermediates (DS manufacturing) Review of master batch records and specifications
CONTINUOUS IMPROVEMENT Support the Pharma Manufacturing (BPM) Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operations Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the site. Using a Risk Based Approach, ensure that all BPM Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures hereby considering objectives, plans and projects Promote quality and operational excellence and cultivate “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the BPM and related supporting services Ensure general cGMP training of internal customers Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements Ensure communication of compliance status and issues to appropriate levels of the organization Ensure a relevant cGMP level regarding subcontractors used to support routine operations for BPM and related supporting services Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections
Your profile: Min 3 years experience in Quality Assurance in a regulated pharmaceutical environment or other life science or health related field Experience with Chemical/ pharmaceutical production, development and /or regulatory requirements, including knowledge production best practices in pharmaceutical industry Experience with Quality Management System Ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision Excellent team player attitude with excellent interpersonal relationship and communication skills Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings Fluent in French and English
Our offer ? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, lena.palmeri@jeffersonwells.be
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