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  • Operations Director

    Operations Director, Galway Our client, a Medtech manufacturing organisation based in Galway, now seeks an Operations Director who will provide leadership onsite, ensuring operations goals and company KPIs are achieved within a regulated cGMP manufacturing environment. The successful candidate will lead strategy, planning, and management of all aspects of operations on the manufacturing site, ensuring that cost, compliance and customer requirements are met. The ideal candidate will be a proven Operations leader, with a demonstrated successful track record of deliver in large regulated commercial manufacturing environments. This hire will exercise a people centered approach in th...

    Job Type:
    Permanent
    Location:
    Galway
    Salary:
    N/A
    Job Ref:
    123786
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  • External Operations, API , Associate Director

    External Operations, API, Associate Director Dublin Our client is a highly successful global pharmaceutical manufacturer. API process expert responsible for being the technical lead representative supporting API manufacturing at Contract Manufacturing Organizations’ (CMO’s). Required to support new product introductions, technology transfers, continually monitor and improve API operations conducted at CMO’s. Job Spec Review and maintain practices & systems in managing contract manufacturers to ensure compliance with cGMP, and other regulatory requirements – ensuring that appropriate policies, rules, regulations and agreements are followed Oversee activities related to API produc...

    Job Type:
    Permanent
    Location:
    N/A
    Salary:
    N/A
    Job Ref:
    123785
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  • Regulatory Affairs Associate Director

    Regulatory Affairs, Associate Director Dublin Unique opportunity to develop and deliver global clinical regulatory strategy Our client is a fast growing highly profitable multinational biopharmaceutical company with a rich exciting pipeline of drug compounds across a diverse range of therapeutic targets at an advanced stage in research. With a hugely experienced and successful executive management team this company has a newly created vacancy for an experienced Regulatory Affairs Associate Director. This newly created position will be located in Dublin with flexibility to work from home. Job Purpose The Associate Director, Regulatory Affairs EU will report to the Head of Regulat...

    Job Type:
    Permanent
    Location:
    Dublin
    Salary:
    N/A
    Job Ref:
    123784
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  • QP Qualified Person

    Qualified Person Part-time Dublin. QP release and certification of all assigned products within the EU & other relevant markets; assuring that the DP batch has been manufactured and checked in accordance with the requirements of its MA and in accordance with the principles and guidelines of GMP & any other legal requirements. Product Certification & Release should be performed in accordance with 2001/83/EC (as amended) and 2001/82/EC (as amended). QP and batch release activities should be in accordance with EU GMP Annex 16: Certification by a Qualified Person and Batch Release. Identify deficiencies in product quality and quality systems. Review and approval of Annual Product Qu...

    Job Type:
    N/A
    Location:
    Dublin
    Salary:
    N/A
    Job Ref:
    123782
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  • Lead Quality Compliance Specialist

    Lead Quality Compliance Specialist My client a leading Pharmaceutical company now require a Lead Internal Auditor to join their expanding team. The Lead Internal Auditor is responsible for leading the internal audit program on site, including supporting regulatory and customer inspections. The Quality Compliance Specialist will have specific and varying duties as assigned by the Quality Systems & Compliance Manager. This is a permanent role based in Dublin and it comes with a good salary with good benefits. Lead Quality Compliance Specialist Manage the internal audit programme including preparation of annual schedule Execution of internal audits as per schedule Oversight of GMP ...

    Job Type:
    Permanent
    Location:
    Dublin
    Salary:
    N/A
    Job Ref:
    123780
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