Sterility Assurance H/F/X

Beschrijving van de functie

Contracting - Brabant Wallon

The QA Ops Aseptic Processes Senior Specialist is responsible for developing, implementing, and overseeing the sterility assurance practices to maintain compliance with regulatory requirements and industry standards. Manage critical and complex major deviations linked to Sterility Assurance (e.g. hidden surface, gradeA/B contaminations etc.) and manage CAPA's in respect to the compliance and the product quality. Approve Environmental Monitoring Risk Assessment, Is the SME for the Sterility Assurance topics in manufacturing units, approve the SOP's related to the subjects, support the Sterility assurance Ops specialists. Approve AQ and aseptic audits (9000002094), coaching during APS is required periodically with the responsibility to assess the overall process and coach people Approve aseptic summary of media sim; Approve or co-approve with the SAM the QMS gap analysis impacting Sterility Assurance topic (e.g. facility design) Is Fronter in audit/inspection for aseptic topics Perform coaching/mentoring of operational/QA Teams, provide Sterility Aseptic training, develop the competencies of the Sterility Assurance shopfloor. Act as a local Sterility Assurance expert / referent Contribute to prepare the major planned technical interventions in classified areas (e.g. shutdown management)

Jouw profiel

Minimum 5-8 years of experience in GMP environment Substantial knowledge of regulatory, GMP, sterile manufacturing, and legal requirements needed. Expertise: aseptic practices/processes, material transfer, environmental monitoring of classified areas, gowning (incl. behaviors in classified areas) etc. Strong knowledge of cGMP and guidelines (FDA/EU/WHO) Demonstrated impact and influence, strong competencies in risk management in order to escalate, to own and to manage risks linked to Sterility Assurance. French speaker with good level of written and spoken English Operational excellence background (Orange-Green Belt) is a plus

Taalvaardigheden

• Frans (troef)

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

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