Pharma Quality Officer M/V/X

Beschrijving van de functie

• Monitor and ensure compliance with Good Distribution Practices (GDP) regulations, guidelines, and standards set forth by regulatory authorities
• Conduct regular audits and inspections of facilities, processes, and documentation
• Collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs)
• Develop, review, and maintain documentation related to GDP compliance
• Implement document control processes to manage revisions, approvals, and archival of quality documentation.
• Perform risk assessments and quality risk management activities
• Conduct internal quality reviews and assessments
• Support the investigation of deviations, out-of-specification results, and customer complaints related to distribution activities, ensuring timely resolution and appropriate documentation
• Lead or participate in quality improvement initiatives, root cause analyses, and implementation of corrective actions to enhance overall quality performance.

SKILLS AND QUALIFICATIONS

• Ability to interpret and apply regulatory standards to ensure compliance in distribution operations.
• Experience in developing and maintaining quality documentation
• Knowledge of QMS principles
• Strong analytical and problem-solving skills
• Ability to lead or participate in quality improvement projects, root cause analyses, and implementation of CAPAs.
• Commitment to ongoing professional development through training.
• In-depth understanding of Good Distribution Practices (GDP) regulations and guidelines
• Knowledge of document control processes, deviation management, CAPA systems, and quality recordkeeping practices.

Taalvaardigheden

• Engels (troef)

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

• Nederlands (troef)

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

Voordelen van de betrekking

BENEFITS

· Full-time contract, undetermined time

· Attractive salary package, including 13th month

· Meal vouchers and ecocheques

· Hospitalization insurance + group insurance

· Transport reimbursement according to CLA PC 226

· 20 vacation days + 6 ADV days + 1 NXB day after 3 years + 1 CLA day after 1 year

· Free coffee, thee, water, soup

· You will be part of a dynamic team

· Benefits Plan ("MyChoice")

· Good Work-Life-Balance, possibility to Work From Home (hybrid or remote model)

· Extracurricular activities (teambuilding, lunches, etc.)

· Training opportunities, internal and external

· Mobile phone & laptop