QC Senior Project Specialist

Found in: beBee S IE - 1 month ago

Dublin, Ireland Cpl Full time

Our client are seeking to recruit a QC Site Operations Projects Senior Specialist to support the QC Site Operations Projects team at its Multi-Product Cell Culture Drug Substance Facility. Reporting to the QC Site Operations Projects Senior Manager, they will support the activities in the Projects team as defined below

 

Key Responsibilities:

 

·      Support the QC teams with continuous improvement projects as part of the QC Projects team portfolio.

 

·      Support of process improvements for onboarding, training plans and method specific training.

 

·      Support of process improvements for investigation reduction and right first time in the QC teams.

 

·      Support Lean labs and automated scheduling tool process improvements.

 

·      Project management of projects assigned to self, including planning, tracking, communication and escalations were needed.

 

·      Strategically plan and implement procedures and systems to maximise operating efficiency through the use of Operational Excellence tools

 

·      Support of operational training activities to support efficiency and compliance across QCSO e.g support onboarding and other training related requests.

 

·      Support of transfers managed by QC Projects team where needed.

 

·      Perform activities to support Drug Substance release e.g tracking, data collation.

 

·      Compliance with Standard Operating Procedures and Registered Specifications.

 

·      Ensure any laboratory process improvements align with the clients Safety culture.

 

·      Approval of SOPs, Training documents etc where required.

 

·      Participate in regulatory agency inspections as required.

 

 

The successful candidate must demonstrate excellent written and verbal communication skills and experience of working with teams and influencing decisions. Experience leading cross-functional teams and knowledge of applicable regulatory requirements is desirable.

 

The ideal candidate should hold a minimum of a third level qualification (Degree) in Science or related discipline along with approximately of 6 years of experience in a pharmaceutical / healthcare laboratory or related technical function.  A strong knowledge of laboratory operation, in particular training and testing requirements from receipt to CoA is required. Involvement in project scoping and tracking is desirable.

 

 

 

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