Quality Officer Pharma
il y a 3 semaines
As a Quality Officer specializing with a focus on Good Distribution Practices (GDP), you will play a crucial role in ensuring the highest standards of quality and compliance within the pharmaceutical distribution process. This role requires meticulous attention to detail, strong regulatory knowledge, and effective communication skills to uphold regulatory requirements and maintain product integrity throughout the supply chain.
**Compliance Oversight**
- Monitor and ensure compliance with Good Distribution Practices (GDP) regulations, guidelines, and standards set forth by regulatory authorities such as the FDA, EMA, and other relevant agencies.
- Conduct regular audits and inspections of facilities, processes, and documentation to verify adherence to GDP requirements.
- Collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs) to address any identified non-compliance issues.
**Documentation management**
- Develop, review, and maintain documentation related to GDP compliance, including Standard Operating Procedures (SOPs), work instructions, and quality records.
- Ensure accuracy, completeness, and traceability of documentation related to the distribution process, including shipping documents, and temperature logs.
- Implement document control processes to manage revisions, approvals, and archival of quality documentation.
**Quality Assurance**
- Perform risk assessments and quality risk management activities to identify and mitigate potential risks to product quality and patient safety.
- Conduct internal quality reviews and assessments to evaluate the effectiveness of quality systems and processes.
- Support the investigation of deviations, out-of-specification results, and customer complaints related to distribution activities, ensuring timely resolution and appropriate documentation.
**Training and Education**
- Develop and deliver training programs on GDP requirements, quality systems, and compliance standards for employees involved in the distribution process.
- Provide guidance and support to personnel to ensure a thorough understanding of their roles and responsibilities in maintaining GDP compliance.
**Continuous Improvement**
- Identify opportunities for process optimization and efficiency improvements within the distribution operations while maintaining compliance with GDP regulations.
- Lead or participate in quality improvement initiatives, root cause analyses, and implementation of corrective actions to enhance overall quality performance.
- Monitor key performance indicators (KPIs) and quality metrics to assess the effectiveness of quality systems and drive continuous improvement efforts.
**Requirements**:
- Developing and maintaining quality documentation, including Standard Operating Procedures (SOPs), and quality records.
- Knowledge of QMS principles and practices to ensure effective management of quality processes and systems.
- Strong analytical and problem-solving skills
- Ability to conduct risk assessments and quality risk management activities
- Attention to detail and data-driven decision-making
- Excellent communication skills, both verbal and written.
- Ability to collaborate with stakeholders across different departments to implement quality initiatives, address compliance issues, and drive continuous improvement.
- Ability to lead or participate in quality improvement projects, root cause analyses, and implementation of corrective and preventive actions (CAPAs).
- Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment.
- Time management skills to meet deadlines, respond to regulatory requests, and ensure timely completion of quality-related activities.
- Commitment to upholding ethical standards and integrity in all quality-related activities.
- Willingness to stay updated on industry trends, regulatory changes, and best practices in pharmaceutical quality and distribution.
- Commitment to ongoing professional development through training.
- In-depth understanding of Good Distribution Practices (GDP) regulations and guidelines issued by regulatory authorities such as the FDA, EMA, and other relevant agencies.
- Professional terminology in ENG and NL. Japanese is an asset.
- Knowledge of MS Office
**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 holidays + > 10 extra days
- Mobile phone + subscription
- Free coffee, tea, water, soup
- You will be part of a dynamic team
- Benefits Plan (“MyChoice”)
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