QC Specialist NPI

4 days ago

Cork, Cork, Ireland Cpl Full time

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

MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it 

contact  Jenn Dinan  on or email 

QC Specialist NPI

The candidate must have a sound technical knowledge of analytical techniques and knowledge of related laboratory equipment in one or more of the following areas: Chemistry, Biochemistry or Microbiology. The candidate must have prior experience of working in an FDA/EMEA regulated facility.

The individual will be responsible for:

·Acts as the QC representative for the site cross functional team for new product introduction (NPI).

·Co-ordinates & plans activities related to the successful transfer of Analytical Methods for NPIs being introduced to the site

·Acts as the QC product owner responsible for APR/PQR, CPV trending for batch related testing,
• Represents QC in global analytical teams related to Commercial Products and NPIs

·Writing, reviewing and approving regulatory documents for NPIs

·Completes Qualification of analytical equipment to support method transfers.

·Co-ordination of Raw material, Utilities, In Process, Final Bulk and Final product analytical testing and sampling.

·Partners with other Departments and Team Leaders to ensure that activities related to QC are completed in an efficient manner.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;


• Supports Team leader on day to day testing operations.


• Performs Data and QC Investigations review and approval.


• Reviews Specifications and plans for associated LIMS scheduling.


• Reviews and approves deviations, CAPA's, Change Control.


• Plans and oversees lab related projects, ie., Method transfers, Equipment Qualification etc.,


• Proactively identifies and drives lab process improvements.


• Trains laboratory team on specific analytical technology.


• Provides superior technical support on specific analytical technology.


• Supports lean initiatives in the area of lab operations, ie., test method execution, documentation updates and equipment qualification etc.

KEY COMPETENCIES REQUIRED:
•

·Collaboration and team work

·Strategic thinker

·Problem solving and attention to detail

·Results and performance driven

·Coaching and mentoring style

·Integrity, trustworthiness and objectivity

·Customer focus
• Clear communication skills

·Adaptable and flexible

·Innovative

·Inclusive, facilitative style

QUALIFICATIONS AND EXPERIENCE:ESSENTIAL

·BSc or higher in Science related discipline

·A minimum of 3 years experience within the Pharmaceutical Industry

·Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals

All applications will be treated with the strictest of confidence

CV's to or apply via the link

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