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Project Manager - Quality Control

Project Manager - Quality Control

  • Location:

    Dublin

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Next Generation

  • Contact email:

    Nuira.Esmau@nextgeneration.ie

  • Job ref:

    JOB-13660_1701251634

  • Published:

    3 months ago

  • Duration:

    24 Months

  • Expiry date:

    2023-12-29

A temporary QC Project Manager reporting to the Quality Control Director, responsible for managing the Quality Control start-up activities associated with a new state of the art Sterile Drug Product Manufacturing facility.

Key Responsibilities

  • Overall responsibility for identifying, defining, scheduling, coordinating and driving to completion all Quality Control Projects within the remit of the Sterile Drug Product facility start-up operations.
  • Work with the QC Projects team to ensure the delivery of Method Transfer activities under the remit of the Sterile Drug Product Facility Start Up.
  • Compliance with all BMS Policies, Standard Operating Procedures and Registered Specifications.
  • Ensure the new laboratory within the Global Biologics Laboratory Building is set up to meet the needs of the new Sterile Drug Product Facility
  • Ensure the new GBL laboratory is set in a safe manner with Safety as a primary concern in its design.
  • Work closely with each of the QC teams to ensure they are informed of critical milestones, progress and support requirements.
  • Provide an effective and efficient QC Service to the Sterile Drug Product Project team through strong communication and focus of key priority milestones
  • Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
  • Review and Approval of project strategy reports, protocols and associated Project documentation.
  • Participate in regulatory agency inspections as required.
  • Strategically plan and implement procedures and systems to maximise operating efficiency through the use of Operational Excellence tools.
  • Manage and contribute to the achievements of department productivity and quality goals.
  • QC Point of contact at all SDP meetings, liaison with network SMEs such as Micro CoE, ASO and MS+T
  • Build schedules and ensure delivery timelines are met
  • Manage headcount and hiring schedule in line with agreed timeframe. Ensure new hires ready to support key activities and meet site timelines.
  • Support Equipment Qualification timelines, URS generation, Attend FATs
  • Ensure all equipment, lab design, methods are accounted for and can be introduced successfully into SDP site
  • Troubleshooting issues and resolving problems

Qualifications & Experience

  • Minimum of a BSc in Science or related discipline
  • Minimum of 8 years hands on experience in a GMP Laboratory Setting
  • 4 years Project Management / People Management experience
  • Strong background in Quality and Aseptic Manufacturing is required
  • Personal and Project management skills
  • Experience leading cross-functional teams