Qualified Person

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex 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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Ringaskiddy, Cork, Ireland

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Innovative Medicine a Qualified Person to join our Johnson & Johnson site in Ringaskiddy, Cork, Ireland.

As a Qualified Person:

This position is responsible for controlling batch release as per Annex 16 to the EU Guide to Good Manufacturing Practice.

The responsibilities and the impact YOU will have: 

• Responsible for certifying DSP batches prior to release to filling site
• Ensure that the batch and its manufacture comply with GDP; GMP; Marketing authorization; IMPD; Import License etc, depending on the product requirements
• Maintain oversight of Quality Issues and change controls and ensures that any issues which have a regulatory impact are notified to health authorities and mitigated as required
• Ensures that all necessary tests and checks have been performed prior to batch release.
• Ensures that all necessary production and quality control documentation has been completed and endorsed by authorized staff
• Attends QMR review meetings to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required
• Maintains knowledge and understanding of quality oversight for services and operations which are outsourced to CMO's / contract test labs
• Maintain knowledge and experience up to date. If a new product type is introduced the QP should ensure that they have gained the relevant knowledge and experience necessary to complete QP duties.

Maintains oversight of issues/escalations related to batches post release ensuring that appropriate actions are taken as required.

· Supports QA colleagues with product quality / license impact assessment for Quality Issues.

KEY COMPETENCIES REQUIRED:

· Excellent interpersonal skills

· Management skills: Problem solving; statistical thinking; design of experiments

· Keeps up to date with the regulatory, technical developments in the industry that will affect products on-site

· Attention to detail

· Always maintains focus on patients and customers

· Maintains the highest standards of ethical behaviour.

We would love to hear from YOU, if you have the following essential requirements:

· At least 2 years relevant experience within regulated biologics / pharmaceutical industry and have fulfilled the educational requirements as outlined in Article 49 of Directive 2001/83/EC.

· Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply GMP regulations and other relevant international guidelines to all aspects of the position.

The anticipated base pay range for this position is 63,300.00 to 101,315.00.

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

This is what awaits YOU at J&J:

 This is an opportunity to work with a ground-breaking biomedicine operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.

We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.

 

 

Required Skills:

 

 

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)