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Contract: Qualified Person - Compliance / North Holland

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Location: Haarlem, North Holland

The client are currently recruiting a Qualified Person - Compliance based in the North of Holland.

Qualified Person - Compliance

Essential Duties and Responsibilities:

Local Quality System deployment :

  • Ensure GMP &GDP compliance at the commercial unit
  • Propose initiatives on continuous improvement of processes

Operational implementation Quality Management System (QMS):

  • QP certification

o Ensure QP batch certification according to GMP Annex 16 for products for NL market as well as European Countries

  • Change control, deviations and CAPAs
    • Administer, maintain and develop systems for change control, deviation and CAPA handling
  • Suppliers/customers and 3rd party service providers
    • Maintain and monitor a list of approved suppliers/customers/providers
    • Ensure Quality Agreements are drawn up and kept updated with all local suppliers/customers and 3rd party service providers as required
  • Ensure managing the portfolio with respect to new introductions, site changes and technical transfers to be in compliance with EU GMP standards
  • Subcontracting
    • Handling a subcontracting activity
  • Archiving

Ensure relevant quality-related documentation is archived as required

Critical Quality Incidents:

  • Escalate to Regional Commercial Quality Head critical quality issues raised at the local level
  • Ensure local deployment of action plan related to quality incidents

Authorities Inspection readiness:

  • Ensure permanent authority inspection readiness
  • Define inspection CAPA plan and submit it for approval to Sub Regional Commercial Quality Head

Education Required:

  • Master´s Degree in Pharmacy, Medicines, Biology or an equivalent combination of education and experience to the functional role to register as a QP Education Preferred
  • Post-graduate or Doctoral degree in Pharmacy, Medicines, Biology or similarly related fields of specialization

Experience Required:

  • Minimum of 5-year experience as a QP in a pharmaceutical company or importer/distributor

Experience Preferred

  • Minimum of 5-year experience as a QP in a pharmaceutical company or importer/distributor specialized or Technical Knowledge Licenses, Certifications needed
  • Demonstrated knowledge and working experience with QP regulations
  • In-depth knowledge of the pharmaceutical industry as it relates to Quality Compliance
  • Working knowledge of pharmaceutical operations
  • In-depth understanding of cGMP & GxP's regulations
  • Experience with development and implementation of Quality Systems and application of risk assessment tools
  • Proficient computer skills in current software including MS Office
  • Excellent English

How to Apply

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