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GDP Operations EMEA/ APAC Manager

Ref: JN-012023-385615

Posted on 11 January 2023
Category
Life Sciences

Great opportunity of 12 months for a leader in the pharmaceutical industry as GDP Operations EMEA/ APAC Manager.

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, non-conformance 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/ non-conformance.
  • 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 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.
  • 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 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.
  • Ability to apply GDP regulations and international guidelines to all aspects of the position.
  • Demonstrated knowledge and application of industry regulations as they apply to quality, including those of HPRA, EMEA, FDA and other authorities.
  • 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 problem-solving skills

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