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Distribution Operations Emea/ Apac Manager
vor 2 Wochen
Responsibilities:
- Responsible for supporting the maintenance of the Quality Management System for EMEA/APAC.
- Hold role as interface with In-Market Quality and Global Supply Chain Compliance colleagues.
- Prepare, update, and approve procedures in accordance with GMP/ GDP and company requirements.
- Change control, nonconformance investigation, supporting internal/ corporate and health authority inspections, supply chain projects, compilation of metrics and document management.
- 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/ nonconformance.
- To review executed forms (destruction, redeployment) and ensure GDP requirements are met.
- Management of complaints, ensuring they are dealt with effectively.
- Escalate any complaints, reported defects, reported falsified medicinal product.
- Lead technical or risk assessment exercises where needed including contracted activities which may impact on GDP.
- Execute adhoc reviews of processes and procedures and provide support in collaborating with Compliance Excellence on executing the selfinspections per defined intervals) and implement corrective actions as necessary.
- Ensure that the quality,safety and traceability of medical products are maintained within the supply chain.
Qualifications:
- Bachelor's Degree in a Scientific/ Technical discipline required
- A minimum of 58 years' experience in a Quality or compliance role within the Pharmaceutical industry, most specifically in relation GDP.
- Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use
- Up to date knowledge of relevant pharmaceutical legislation and GDP.
- Excellent interpersonal and Innovative skills
- Ability to operate as part of a team is critical.
- Excellent communication skills both written and verbal
- Attention to detail, adaptable and flexible, 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 problemsolving skills
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