NL Compliance Officer

We are seeking a combined Compliance Officer to join our team in Rozenburg, Netherlands. As a Compliance Officer, you will support the Trade Compliance team and serve as backup for the Branch DCM. You will ensure district-level compliance with company policies and applicable trade laws and regulations.

Responsibilities

• Support the Trade Compliance team and serve as backup for the Branch DCM
• Ensure district-level compliance with company policies and applicable trade laws and regulations
• Act as the Deputy Responsible Person/Designated Person, supporting the NL RP/DP (Healthcare Manager)
• Maintain full RP/DP qualification and license registration
• Support GDP compliance in AMS and ensure adherence to WDA license requirements and regulatory obligations

Quality Management

• Support the DCM in creating a tone of compliance in the branches
• Perform regular audits on TC focus topics
• Support implementing preventive controls and corrective actions
• Quality risk management
• Corrective and preventative actions (CAPA) to address deviations
• Change control and Measurement of performance indicators and management review

People

• Support training programs are implemented and maintained
• Ensure all personnel are trained in Trade Compliance and GDP
• Monitor training records

Premises & Equipment

• Support appropriate standards of GDP are maintained for own premises and contracted storage premises
• Maintain the safety and security of medicinal products within the appropriate environments
• Ensure storage areas are temperature mapped, qualified and validated

Documentation

• Ensure the accuracy and quality of records
• Records storage
• Maintaining comprehensive written procedures that are understood and followed

Operations

• Assist operations with screenings and pre-checks
• Execute regular file audits focusing on compliance areas of concern
• Support complete monthly branch assessments
• Monitor and control TC reports on branch workflow based on compliance reports
• Report any anomalies according to escalation procedures

Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls

• Ensure relevant customer complaints are dealt with effectively
• Inform the manufacturer and/or marketing authorization holder of any product quality/product defect issues
• Support with final disposition of returned, rejected, recalled or falsified products

Outsourced Activities

• Support with regular audits of GDP approved service providers

Self-Inspection

• Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program
• Necessary corrective measures are put in place

Transportation

• Apply the appropriate transport requirements and methods for cold chain, ambient and hazardous product
• Ensure all transport equipment is appropriately qualified

Management of Active Pharmaceutical Ingredients (API) & Active Substance Registration (ASR)

• The Back-up Responsible Person is also the Designated Person for Active Substances, as per Directive 2011/62/EU (Falsified Medicines Directive)

Qualifications

• Prior relevant knowledge and experience related to Compliance and the distribution of medical products
• Access to pharmaceutical knowledge and advice when it is required
• The local regulatory regulations in relation to wholesale distribution
• The European Pharmaceutical Directive related to wholesale distribution of medicinal products
• Good Distribution Practice (GDP) licensed

Additional Information

• All your information will be kept confidential according to EEO guidelines.