Pharma Quality Officer
Functieomschrijving
- 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.
Aanbod
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