QC IP Specialist
Veröffentlicht:
26 September 2024Pensum:
100%Vertrag:
Festanstellung- Arbeitsort:Janssen
Position Title: QC IP Specialist
Department: QC
Report to: QC Manager
Location: Janssen, Ringaskiddy
Closing Date: 26th September
Johnson & Johnson Innovative Medicine Ringaskiddy are recruiting for a QA Team Lead.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where sophisticated diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to build a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to tackle the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver significant solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we cultivate a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.
At Johnson & Johnson, we all belong.
Duties and Responsibilities
- 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 or Microbiology.
- The individual will be responsible for:
- Qualification of analytical equipment and related testing functions eg HPLC, Spectrophotometry, microbiological API and aseptic release, Total Organic Carbon etc.
- Testing coordination during plant and laboratory utility qualification.
- Co-ordinates & plans activities related to the successful transfer of Analytical Methods.
- Co-ordination of Raw material, Utilities, Intermediate, and API product analytical testing and release.
- Implementation of Analyst Training programs and implementing analyst training.
- Partners with other Departments and QC Team Leader to ensure that activities related to QC are completed in an efficient manner.
- Supports QC team by effectively troubleshooting laboratory issues.
- Supports site/product investigations as required.
- Reporting to the QC Manager 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 and approves deviations, CAPA’s, Change Control.
4. Plans and leads all aspects of lab related projects, ie., Method transfers, Equipment Qualification etc.,
5. Proactively identifies and drives lab process improvements.
6. Trains laboratory team on specific analytical technology.
7. Provides outstanding technical support on specific analytical technology.
8. Supports lean initiatives in the area of lab operations, ie., test method execution, documentation updates, equipment qualification. 5S and A3 etc
9. Presents clear and concise data to customers, i.e., internal investigations and regulatory inspectors etc.,
10. Stays ahead of analytical technology and compliance trends.
11. The candidate must stay in sync with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures and duties outlined in the Safety Health and Welfare at work Act.
Minimum Requirements
Key Proficiencies Required:
- Collaboration and partnership.
- Strategic problem solver.
- Results and performance driven
- Coaching and mentoring style
- Integrity, trustworthiness and objectivity
- Customer focus
- Clear communication skills
- Adaptable and flexible.
- Innovative
- Inclusive, facilitative style