Introduction

For an important industrial pharmaceutical company based in canton of Neuchâtel, we are looking to recruit for a temporary contract 12 month a

GDP Operations EMEA / APAC Manager 100%
 

The GDP Operations EMEA/ APAC manager is responsible for supporting the maintenance of the Quality Management System for EMEA/APAC. These activities include change control, non-conformance investigation, supporting internal/ corporate and health authority inspections, supply chain projects, compilation of metrics and document management. This role will interface with In-Market Quality and Global Supply Chain Compliance colleagues.

Description de la mission

• Prepare, update, and/or approve procedures in accordance with GMP/ GDP and company requirements
• Manage all documents in accordance with records management procedures and data integrity requirements
• Serve as the Local Process Owner in the execution of QMS activities, compliance initiatives, best practices, and industry standards per implementation strategy
• Monitor deviations, internal and external change controls and CAPAs, standalone actions to ensure progression and timely closure.
• Develop responses to internal audits and ensure appropriate implementation of corrective actions as required
• Support and participate in local initiatives or projects to increase compliance and reduce costs/ non-conformance.
• To review executed forms (destruction, redeployment, etc) and ensure GDP requirements are met .
• Ensure that the quality, safety and traceability of medicinal products are maintained within the supply chain.
• Management of complaints, ensuring they are dealt with effectively
• To escalate any complaints, reported defects, reported falsified medicinal product
• To lead technical or risk assessment exercises where needed including contracted activities which may impact on GDP.
• To execute ad-hoc reviews of processes and procedures and provide support in collaborating with Compliance Excellence on executing the self-inspections per defined intervals) and implement corrective actions as necessary.

Profil attendu

• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Excellent communication skills both written and verbal
• Attention to detail
• Results and performance driven
• High customer orientation, excellent interpersonal, communication and teamwork skills
• Ability to build trustful relationships, engage and influence stakeholders at all levels, including market and GPS leadership
• Excellent analytical, organizational, and problem-solving skills