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 and 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

For 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.

For 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

Have an awareness of the issues surrounding falsified medicines

Outsourced Activities

Support with regular audits of GDP approved service provides

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