Pharmaceutical & Biotechnology

Tech Transfer Lead

  • Contract
  • South Dublin, County Dublin, Ireland
  • 42000691

PE Global is currently recruiting for a Tech Transfer Lead for a leading multi-national Biotech client based in Dublin South.

This is an initial 12-month contract position. This role will require the ability work a 4 cycle shift days and nights (2-3 times over the course of the year shift will be required).

ROLE:

 Development of validation plans, process performance qualifications for vial and syringe filling.
• Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
• Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
• Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
• Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
• Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
• Act as the responsible point contact from ADL site for the transfer project for drug product teams and Global Operations Teams.
• Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.
• Collate and report on relevant shipping and filter validation.
• Assist in deviation and exception resolution and root cause analysis.
• Contribute to product quality assessments and process flow documents.

 

REQUIREMENTS:

  • Third level Bachelor’s degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience.
  • Knowledge of cGMPs and other worldwide regulatory requirements.

Interested candidates should submit an updated CV.

Please click the link below to apply,  or alternatively send an up to date CV to rebecca@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

 

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