Pharmaceutical & Biotechnology
QC Project Manager
- North Dublin, County Dublin, Ireland
PE Global is currently recruiting for a QC Project Manager for a leading multi-national Pharma client based in Dublin.
This is a 12 contract position.
- 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
- 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
• Knowledge of applicable regulatory requirements is desirable
• Excellent written and verbal communication skills
Interested candidates should submit an updated CV.
Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up to date CV to email@example.com.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***