Overview
Team Horizon is seeking a CW Validation Lead (Senior) for our client in Dublin.
Validation lead for a large-scale Fill Finish Project in the Pharmaceutical Industry.
Lead a team of Validation engineers to ensure the Validation activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
Why you should apply
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing
Coordinates and Supervises all Validation activities
Approves Validation planning documents detailing overall strategy for the project.
Develops and approves the master list of Validation test documents and activities.
Reviews and Approves all C&Q summary reports and Validation Summary reports.
Ensures the Validation schedule is developed and maintained.
Ensures all Validation Engineers who perform Validation activities have relevant training assigned.
Pre-Approval and Post approval of Validation test documents.
Manages Validation coordination meetings.
Responsible for Overall Tracking and Reporting of Validation status and risks/issues.
Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
What you need to apply
BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality
Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects
Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
- Demonstrated strong Communication and Leadership skills.
Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry
In-depth understanding and application of validation principles, concepts, practices, and standards.
In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing
Working knowledge of sterilization/decontamination systems and industry practices.
Experience with AVS (Airflow Visualization) Studies.
Experience of aseptic processing
#J-*****-Ljbffr