25 days ago
We are seeking a QC Analytical Services Senior Specialist to write and continuously improve the protocols for 5 Contract Testing Labs.
The ideal candidate will have experience writing and developing protocols for sample testing and experience with verification and validation.
The role is hybrid, based out of Dublin 15, A 12 month fixed term contract.
Key Duties and Responsibilities:
* Management of CTL forecasting for various sample types
* Tracking sample shipments and testing status at contract test labs
* Results entry from CTL CoA in electronic laboratory system
* Coordination of contract test lab method and specification updates
* Managing investigations and deviations in QC and the CTL's, in conjunction with Technical Lead, area SME's
* Prioritization of workload in the CTL's
* Communication to global and local stakeholders on status of testing in CTL's
* Support process improvements to standardize the management of all CTL's
* Participate in the OpEx strategy and support process improvements
* Support additional QC analytical services activities, as required
Additional responsibilities will include;
* Management of method & specification Management and Compendial Updates
* Gather feedback from all areas impacted by changed proposed for implementation
* Support completion of impact assessments
* Inform relevant groups (e.g.: bioassay or raw materials) on the proposed/implemented changes
* Collect feedback from the affected area designees
* Provide feedback to global Compendial Affairs team within the due date
* Track relevant quality records to maintain implementation of the change in the facility
* Update relevant local procedures if applicable
Qualifications, Knowledge and Skills Required:
* The ideal candidate should hold a minimum of a B.Sc. in Biochemistry or related discipline and must have at least 3 years' experience, in a GMP laboratory setting ideally within a biologics laboratory.
* An understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories is desirable, in particular raw materials and microbiology testing requirements.
* Excellent communication skills are critical.
* The successful candidate must also demonstrate excellent time management and organisational skills.
The Next Step for you:
Should this position be of interest to you please forward your CV to Nuira Esmau at Next Generation Recruitment via the Apply button. Next Generation are specialists in recruiting for roles in Data Science, Digital, Engineering & Life Sciences, IT, Supply Chain & Operation, Engineering and are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.