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Country Quality Release Officer

Job description

The Country Quality Release Officer – Qualified Person

  • Is part of the Country Quality organization, which - as a whole - creates, maintains and monitors the quality management system

  • Is responsible for preparing and/or performing market and distribution release and batch (import) certification of medicinal products.

  • Is responsible for GMP oversight and for maintenance of the applicable procedures and compliance to the current legislation, and for deviation, change control, complaint, CAPA and incident management within his/her area of expertise.

  • Drives cross-divisional standardization and efficiency gains through innovation and operational excellence.

  • Is, in close collaboration with Country Quality Head and Head of Release

 JOB DESCRIPTION

  • Perform duty of care checks for all batches of medicinal products (transport conditions and documentation thereof, availability and completeness of batch documentation, correctness of used printed packaging materials) and this in accordance with the registered product specifications and with national and international legislation

  • Perform QP batch (import) certification and release for market and distribution of medicinal products in accordance with the marketing authorization and GMP requirements

  • In case of local repackaging activities,

    • Prepare, execute, release local repackaging activities

    • Responsible for batch record review and oversight of outsourced activities

  • Deviation, change control, complaint, CAPA and incident management within his/her area of expertise

  • Evaluate and approve Product Quality Reviews

  • Escalate product quality issues to management and is the main contact with competent authorities; contactable 24/7

  • Ensure relevant procedures are established, implemented and maintained, within his/her area of expertise

  • Artwork quality review and approval for commercial products

  • Deliver successful GxP inspections and internal audits, within his/her area of expertise

  • Participation in the NCQ organization’s back-up system to ensure business continuity

  • Create and maintain strong collaborative relationship with all internal & external customers (such as warehouse and manufacturing sites)

  • Ensure training compliance

Skills and personality
  • Degree in Life Science + QP certification or degree in industrial pharmacy (minimum 1 year)

  • Registration on the list of Qualified Persons as required in RD 14/12/2006

  • Strong knowledge of GMP/GDP and work experience in a quality organization

  • Languages: Dutch, French and English fluent

  • Excellent communication and diplomacy skills

  • Excellent administrative management skills

  • Good interpersonal savvy

  • Living ethics and values

  • Eye for detail, accuracy and punctuality

  • Ability to read, interpret and transcribe data accurately

  • Good sense of organization, planning, priority setting and initiative

  • Open, pro-active and positive mindset, agile, flexible & resilient even when resistance

  • Pragmatic, eager to learn, problem solving mindset, business acumen and corporate mindset

  • Hands-on experience with MS excel and other electronic platforms such as SAP, Trackwise

Contract

Executive search

Experience

minimum 2 years

Education

Industrial Pharmacist

Languages

Dutch, English, French

Sector

Pharmaceutical industry

Region

Brussels

Job type

Full-time

 
 

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