Contract: Qualified Person - Compliance / 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