Packaging Validation Team Lead
As a Packaging validation Team Lead you will be responsible for leading a cross functional team to ensure that the Validation Activities associated with the Packaging and Labelling and Shipping of Sterile Filled Syringes and Vials are in compliance with Division Quality System requirements and recognised international standards.
Development of Validation Strategy, Plans and development of Installation Verification, Functional Testing and Performance Qualifications (PQs) for Vial and Syringe Packaging for a large scale packaging operations.
Working with the Packaging team to ensure all aspects of activity within the Packaging Validation adhere to required policies and procedures, including safety and training.
Ensure that the PAckaging Validaiton meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
Review, Approve and execute validation protocols and can complete risk assessments from a quality system perspective.
Assist with Engineering and external vendors regarding equipment SA
Schedule and coordination implementation of any existing Validation program to ensure continued compliance to the necessary regulations.
Lead deviation and exception resolution and root cause analysis.
Develop and rollout Validation Training for the site on subjects assigJob Description
Packaging Validation Team Lead
As a Packaging validation Team Lead you will be responsible for leading a cross functional team to ensure that the Validation Activities associated with the Packaging and Labelling and Shipping of Sterile Filled Syringes and Vials are in compliance with Division Quality System requirements and recognised international standards.
Development of Validation Strategy, Plans and development of Installation Verification, Functional Testing and Performance Qualifications (PQs) for Vial and Syringe Packaging for a large scale packaging operations.
Working with the Packaging team to ensure all aspects of activity within the Packaging Validation adhere to required policies and procedures, including safety and training.
Ensure that the PAckaging Validaiton meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
Review, Approve and execute validation protocols and can complete risk assessments from a quality system perspective.
Assist with Engineering and external vendors regarding equipment SA
Schedule and coordination implementation of any existing Validation program to ensure continued compliance to the necessary regulations.
Lead deviation and exception resolution and root cause analysis.
Develop and rollout Validation Training for the site on subjects assig
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
