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Qualified Person - Compliance

  • Job reference: 931534
  • Location: Haarlem, North Holland
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 30/07/2020

Orion Group are currently recruiting a Qualified Person - Compliance on behalf of one of our Multinational Pharmaceutical Clients 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

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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