Gdp Operations Emea/ Apac Manager

Vor 4 Tagen

Basel, Schweiz LHH Vollzeit

I am looking for my client, international pharmaceutical industry located in Boudry, a GDP Operations EMEA/APAC manager for 12 months.

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.

Your 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.

Your profile:

- Bachelor’s Degree in a Scientific/ Technical discipline required.
- A minimum of 5-8 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.

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