Nl Compliance Officer

Combined Compliance Officer Role

Trade Compliance: 3 days / Healthcare Compliance: 2 days

Compliance

• 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.

Healthcare Compliance

• 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

• Compliance: Support the DCM in creating a tone of compliance in the branches. Perform regularly audits on TC focus topics, support implementing preventive controls and corrective actions.
• Healthcare GDP: 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, all personnel are trained in Trade Compliance and GDP and 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, including product integrity and product storage.
• Maintain records for the repair, maintenance, calibration and validation of equipment including computerized systems.
• Ensure storage areas are temperature mapped, qualified and validated.

Documentation

• The accuracy and quality of records.
• Records storage.
• Maintaining comprehensive written procedures that are understood and followed.
• Ensure procedures are valid and version controlled.

Operations – support with

• Compliance: Assist operation with screenings and pre-checks, execute regular file audits focusing on compliance areas of concern and support complete monthly branch assessments.
• Monitor and control TC reports on branch workflow based on compliance reports.
• Report any anomalies according to escalation procedures.
• Proactive support in implementing preventive controls and understanding performance of all departments for both branches.
• HC: Support due diligence checks, necessary checks and authorized activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP.
• Co-operate with marketing authorization holders and national competent authorities in the event of recalls.

Complaints, returns, suspected falsified medicinal products and medicinal product recalls

• Ensure relevant customer complaints are dealt with effectively, informing 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.
• Coordinate and promptly perform any recall operations for medicinal products.
• Co-operate with marketing authorization holders and national competent authorities in the event of recalls.
• Have an awareness of the issues surrounding falsified medicines.

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 and 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).

The back-up responsible person should fulfil their responsibilities personally and should be contactable in absence of the RP/DP.

Requirements

• 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.
• Employ due diligence in the discharge of their duties, maintaining full compliance with procedures and appropriate regulations.

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