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 oremail.
Responsibilities:
The individual will be responsible for:
1. Acts as the QC representative for the site cross-functional team for new product introduction (NPI).
2. Coordinates & plans activities related to the successful transfer of Analytical Methods for NPIs being introduced to the site.
3. Acts as the QC product owner responsible for APR/PQR, CPV trending for batch-related testing.
4. Represents QC in global analytical teams related to Commercial Products and NPIs.
5. Writing, reviewing, and approving regulatory documents for NPIs.
6. Completes Qualification of analytical equipment to support method transfers.
7. Coordination of Raw material, Utilities, In Process, Final Bulk, and Final product analytical testing and sampling.
8. Partners with other Departments and Team Leaders to ensure that activities related to QC are completed efficiently.
General 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. Supports Team leader on day-to-day testing operations.
2. Performs Data and QC Investigations review and approval.
3. Reviews Specifications and plans for associated LIMS scheduling.
4. Reviews and approves deviations, CAPA’s, Change Control.
5. Plans and oversees lab-related projects, i.e., Method transfers, Equipment Qualification, etc.
6. Proactively identifies and drives lab process improvements.
7. Trains laboratory team on specific analytical technology.
8. Provides superior technical support on specific analytical technology.
9. Supports lean initiatives in the area of lab operations, i.e., test method execution, documentation updates, and equipment qualification.
Qualifications and Experience (Essential):
1. BSc or higher in 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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