A Leading Dublin based biotech organisation requires a QA (Quality Assurance) Manager to support their Global Distribution/ Shipping and logistics from their state-of-the-art manufacturing facility in line with regulatory standards and GDP (Good distribution Practice).
- Manage Distribution Quality Support group. Provide quality support for our clients' Global Supply Chain in Logistics, Customer Operations, and Commercial Distribution functions.
- Supporting the Responsible persons/ Quality Managers in distribution related quality management systems.
- Own GDP processes and procedures applicable to multiple entities/markets. Collaborating with RPs and equivalent Country Quality Managers, drive continuous improvement and harmonization/optimization of processes / procedures.
- Develop and enhance training materials related to GDP as needed.
- Define and monitor standard quality KPI and review quality indicators with recommendation for actions for improvement.
- Attend and develop Distribution related Quality Management Review meetings
- Collaborate with appropriate RP and Country Quality Managers to provide quality oversight for cold chain validation activities.
- Act as QA technical contact point with Country Quality Managers at affiliates. Provide guidance, drive and monitor Quality issues related to cold chain and GDP to resolution within the company and with external parties.
- Collaborate with Responsible Person, review documentation including but not limited to Quality Agreements, change controls, deviations, validation documentation, SOPs and specifications
- Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
- Support Responsible Persons in relevant region to ensure compliance with the general conditions of the Wholesale Distribution Authorizations and ensure compliance with the requirements of GDP.
- Demonstrable experience in international pharmaceutical and/or bio tech industry with increased level of responsibility
- Experience in QA and GDP
- Experience in managing contractors
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
- Demonstrated success records in improvement processes
- Ability to operate efficiently in a complex matrix organization and international environment
- Management skills for management of a team of Specialists/Sr. Specialists,
Please apply with your CV now for this contract opportunity for a chance to work with a growing global organisation on their expanding global distribution network.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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