QC IP Specialist - 2406212840W

Description

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 worlds 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, CAPAs, 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 companys 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

Qualifications

Qualifications and Experience * *Crucial:

• A minimum of 3 years experience within the Pharmaceutical Industry.

• Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals.

Key Individual Contributor Proficiencies:

• Builds strong positive relationships

• Demonstrates ability to work with teams and individuals

• Asserts personal ideas and opinions using persuasion to influence others

• Seeks opportunities to grow and develop professionally

• Uses standard methodologies to improve business operations

• Holds self accountable for compliant and detailed execution

• Takes personal responsibility for decisions that successfully build customer value

• Optimally leads and adapts to change

• Demonstrates the courage to stand alone on ideas and opinions that differ from other.

• Listens efficiently and remains open to others ideas.

• Works effectively with people that have diverse styles, talents and ideas

• Maintains the highest standards of ethical behavior.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Primary Location Europe/Middle East/Africa-Ireland-Cork-Cork

Organization Janssen R&D Ireland (7566)

Job Function Quality Control

Req ID: 2406212840W