CK Group are recruiting for a Technical Transfer Lead to join a biopharmaceutical company at their site based in Dun Laoghaire on a contract basis for 12 months.
Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis.
This Technical Transfer Lead role will be based at our clients site in Dun Laoghaire, County Dublin.
Up to ?56 per hour, depending upon experience.
Technical Transfer Lead Role:
- Development of validation plans, process performance qualifications for vial and syringe filling.
- Ensure 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.
- Third level Bachelor\'s degree in Science, Engineering or a relevant quality discipline or equivalent working experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Extensive experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
For more information or to apply for this Technical Transfer Lead position, please contact Natasha on 44 1246 457739 or email firstname.lastname@example.org, quoting job ref 48791.
It is essential that applicants hold entitlement to work in Ireland.
You MUST be eligible to work in Munster. Learn more
- Agency: CK Group
- Contact: Natasha Young
- Phone: 01246 457722
- Reference: 48791
- Posted: 26th August 2020
- Expires: 23rd September 2020