Job Description Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in ****, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.
We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
PSC is hiring a Biotechnician in Cork, Ireland.
Reporting to the Drug Product Team Lead, the successful candidate shall work as part of a team of Sterile Filling Technicians to complete both the manufacturing and visual inspection of sterile drug product as per the schedule for onward processing in the packaging facility.
The candidate will be required to work closely within a cross-functional team including other Sterile Filling Technicians, Maintenance Technicians, Quality, Material Operations, Supply Chain and others.
Requirements This role requires flexibility with regards to work schedules.
This role is currently a 3-Shift rotation (3 Shift Rota (12hr) + 25%) with potential for future shift work changes as required: · Demonstrate technical knowledge and experience in cleanroom operations incorporating recombination and pooling of Drug substance and aseptic filling in an isolator environment.
· Perform all operational tasks related to recombination, pooling, sterile filling and visual inspection in accordance with established procedures.
· Responsible for the writing, updating and execution of Batch Records, SOPs and other GMP Documentation.
· Complete detailed batch record and GMP documentation entries which are accurate, attributable, complete, legible clear, original, timely prompt.
· Perform environmental monitoring and routine batch sampling per applicable SOPs.
· Perform housekeeping duties.
· Maintain an exemplary personal training record.
· Pro-actively identifies compliance risks and takes appropriate preventative actions.
· Proactively identify equipment issues and perform root cause analysis, make recommendations and aid in implementation for more complex and reoccurring issues.
· Proactively lead and support continuous improvement initiatives within the sterile filling facility.
· Provide leadership and guidance on shift to support and influence positive behaviour.
· Support investigations into Quality events, including reporting production issues, writing reports and implementing CAPAs, etc. as required.
· Participate in/Lead cross functional team initiatives.
· Participate support site inspections by regulatory agencies.
· Demonstrate commitment to a high level of safety awareness within the sterile filling team.
· Execute all operations activities in a safe manner and in strict accordance to SOPs, cGMP regulations and site Quality standards.
· Support Sterile filling equipment commissioning and qualification.
· Interface with external vendors service providers.
Requirements This role requires flexibility with regards to work schedules.
This role is currently a 3-Shift rotation (3 Shift Rota (12hr) + 25%) with potential for future shift work changes as required: · Demonstrate technical knowledge and experience in cleanroom operations incorporating recombination and pooling of Drug substance and aseptic filling in an isolator environment.
· Perform all operational tasks related to recombination, pooling, sterile filling and visual inspection in accordance with established procedures.
· Responsible for the writing, updating and execution of Batch Records, SOPs and other GMP Documentation.
· Complete detailed batch record and GMP documentation entries which are accurate, attributable, complete, legible