Kenny-Whelan (a specialist division of the CPL group) are hiring a QC Specialist NPI to work on contract within the QC Department at Janssen Sciences in Ringaskiddy Cork.
New vacancy July
Eligibility: MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND - i.e., have a valid work permit with 12 months permission.
Contact: Jenn Dinan on email.
Responsibilities:
The individual will be responsible for:
1. Acting as the QC representative for the site cross-functional team for new product introduction (NPI).
2. Coordinating & planning activities related to the successful transfer of Analytical Methods for NPIs being introduced to the site.
3. Acting as the QC product owner responsible for APR/PQR, CPV trending for batch-related testing.
4. Representing QC in global analytical teams related to Commercial Products and NPIs.
5. Writing, reviewing, and approving regulatory documents for NPIs.
6. Completing Qualification of analytical equipment to support method transfers.
7. Coordinating Raw material, Utilities, In Process, Final Bulk, and Final product analytical testing and sampling.
8. Partnering with other Departments and Team Leaders to ensure that activities related to QC are completed efficiently.
Scope of Responsibilities:
Reporting to the QC Team Leader, the person will advise on various plant-wide testing issues and will be responsible for the following:
1. Supporting Team Leader on day-to-day testing operations.
2. Performing Data and QC Investigations review and approval.
3. Reviewing Specifications and plans for associated LIMS scheduling.
4. Reviewing and approving deviations, CAPA’s, Change Control.
5. Planning and overseeing lab-related projects, e.g., Method transfers, Equipment Qualification.
6. Proactively identifying and driving lab process improvements.
7. Training laboratory team on specific analytical technology.
8. Providing superior technical support on specific analytical technology.
9. Supporting lean initiatives in the area of lab operations.
Qualifications and Experience (Essential):
1. BSc or higher in a Science-related discipline.
2. A minimum of 3 years experience within the Pharmaceutical Industry.
3. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
All applications will be treated with the strictest of confidence.
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