Gdp Operations Manager Emea
vor 3 Monaten
**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**:
**Key Duties and Responsibilities**:
- 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**:
**Qualifications, Knowledge and Skills Required**:
- 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
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