QA Officer Drug Substance H/F/X

Beschrijving van de functie

Contracting - Brabant Wallon

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

Jouw profiel

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

Taalvaardigheden

• Frans (troef)

  • Begrijpen : Vaardig - (C1)
  • Schrijven : Vaardig - (C1)
  • Lezen : Vaardig - (C1)
  • Spreken : Vaardig - (C1)

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