Support in Country Quality and Compliance

Description:

This mission is to cover a maternity leave. The contractor is expected in the office at least 2 days per week.

The main responsibility is to ensure business continuity in the office.

Main activities are described as following.

Country Quality Management

Develop, implement and maintain the companies local Quality Management Systems (procedures).

Applying Quality Risk Management (QRM) principles.

Involved in local management review meetings.

Audits/inspections & Self-Inspections

Management of audits and inspections of the companies local office (e.g. HA, Corporate).

Prepare / Review / Approve Responses / Corrective and Preventive Actions (CAPAs).

Training

Ensure that initial and continuous training programs are implemented and maintained, including assessment of training effectiveness.

Complete trainings as required for role.

Documentation

Ensure Quality-related tasks are included in job descriptions for relevant personnel.

Development and keeping of records for any delegated duties.

Ensure quality and accuracy of documentation and records retention.

Approve and review local procedures with Quality impact.

Product Quality

Tracking, trending or signaling of PQCs.

Handling and routing of suspect Counterfeit, Diversion or Tampering (CDT) notifications.

Deviations

Deviation management, overview and tracking.

Management of CAPAs, including tracking.

Ensure handling of temperature excursions during transport, warehousing and distribution.

Change Management

Ensure Change Control procedure is applied.

Customer and Supplier Qualification

Ensure the customers and suppliers have the appropriate HA authorization to manufacture, warehouse, distribute, or purchase medicinal products.

Ensure transactions are monitored for detection of unusual sales patterns and initiate deviation procedure including HA notification as needed.

Outsourced operations

Participate or ensure due diligence and audits to assess competence and reliability of the client external partner(s).

Review and approve Quality Agreements to ensure inclusion of appropriate Quality elements partner(s).

Approval of any subcontracted activities which may have impact on GDP.

Quality oversight of subcontractors and Third-Party Logistics provider (3PL) to ensure operations (e.g. incoming inspection of the clients products, storage, picking and distribution) complies with regulatory requirements and the conditions specified in the Dossier.

Compliance monitoring (e.g. Visits, meetings, metrics reviews).

Delivery of products

Involved in decision on the final disposition of returned, rejected or falsified products independent from commercial functions or management.

Ensure that any additional requirements imposed on certain products by national law are adhered to (e.g. MIF for immunological products).

Control of incoming goods arrangements.

Ensure or Monitor accuracy of delivery documentation (e.g. Batch Release Certificates).

Warehousing and inventory management

Ensure correct storage conditions are applied and monitored.

Returned Goods Management

Approve deviations from First Expiry First Out (FEFO) principle.

Distribution/transportation

Ensure end-to-end knowledge of transportation conditions from manufacturing site to customer.

Ensure adherence to product storage conditions and special conditions.

Ensure qualified equipment and packaging is used for temperature-sensitive products.

Ensure handling of complaints related to distribution.

Repackaging/re-stickering

Management of repackaging/re-stickering activities in coordination with the Back-up QRP.

Oversight of repackaging/re-stickering activities.

Metrics / Regulatory Compliance

Ensure preparation of Quality Metrics (e.g. deviations, inspection outcomes, PQCs, CAPAs).

Present Quality Metrics to stakeholders (e.g. management, Quality Compliance Council).

Oversee and Track Quality Improvement Actions.

The responsibilities above also include authority to issue instructions, act and take decisions to fulfill HA requirements and to safeguard patient health.

Education

Master Degree in Life Sciences.

Experience in Quality Assurance at least of 2 years.

Good knowledge of Good Distribution Practice.

Good knowledge of the operation of the Supply Chain.

English/Dutch/France.