Project Manager - Quality Control
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Location:
Dublin
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Sector:
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Job type:
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Salary:
Negotiable
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Contact:
Next Generation
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Contact email:
Nuira.Esmau@nextgeneration.ie
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Job ref:
JOB-13660_1701251634
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Published:
over 1 year ago
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Duration:
24 Months
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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
