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    Quality Assurance Manager for QC - Dublin, Ireland - Alexion Pharmaceuticals

    Alexion Pharmaceuticals
    Alexion Pharmaceuticals Dublin, Ireland

    1 week ago

    Default job background
    Full time
    Description

    This is what you will do:

    Responsible for the management and oversight of quality activities associated with QC at ADMF, ensuring commercial, Stability and/or clinical products are tested and approved in accordance with cGMP, Corporate and Regulatory requirements.

    Responsible for ensuring that QC Management, the Director of Quality Operations and the QP group are informed of all critical and major issues and investigations that may impact the quality and/or compliance status of product at Alexion.

    You will be responsible for:

  • Leading and managing a quality team to co-ordinate the quality activities for QC e.g. record closure, Periodic Review, investigation support
  • Acts as Quality point person on behalf of QC, providing guidance and feedback on quality assurance issues
  • Responsible for the quality oversight for QC related activities at Alexion College Park for testing activities, method transfer, method validation, retain and stability program. This includes raw materials, clinical and commercial products for Drug Substance, Drug Product, and Finished Product, including co-packaged products
  • Provide QA oversight and guidance of QC related change controls, Laboratory Investigation Reports, Quality Control deviations, root cause analysis/CAPAs, method transfer documentation, validation and qualification documentation and timely closure as per Alexion SOPs and QMS
  • Supports continuous quality system improvements and support implementation of improvements for Quality Control in Compliance, Deviation Management and the Change Control Programs
  • Provide QA and compliance support to Quality Control (QC) projects
  • Provide support and expertise for inspection readiness activities, during inspections including interaction with inspectors and responses to observations
  • Responsible for quality review and approval of GMP documents, including but not limited to analytical method transfer documentation, policies, operational standards, stability documentation, APQRs in accordance with Alexion's internal procedures and GMP principles
  • Supports QC Management to create an environment for 'right first time' in focusing on principles of lean, visual management and building in efficiencies as necessary

    • You will need to have:

  • Minimum of 8 years relevant experience within the pharma industry or a related field
  • Minimum of 3 years supervisory experience
  • Strong knowledge of cGMP requirements for pharmaceutical manufacturing required
  • Direct experience of GMP management within a pharma/biopharma company is essential, including exposure to FDA, HPRA or other authorities of similar standing
  • Excellent accuracy and attention to detail
  • Good knowledge of relevant computer packages e.g. Trackwise, EQV
  • Planning and organizing skills to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities
  • In depth understanding of current regulatory requirements for QC and up to date knowledge of pharmaceutical legislation and industry practice

    • We would prefer for you to have:

  • Has previously demonstrated success in managing a team.
  • Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written
  • High level technical skills including analytical, auditing, biopharmaceutical manufacturing and regulatory inspection management. Technical writing skills required

    • Date Posted

    24-Apr-2024

    Closing Date

    14-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
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