Job Description Johnson & Johnson Innovative Medicine Ringaskiddy are recruiting for a Qualified Person-12 FTC.
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 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 create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve 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.
This position is responsible for controlling batch release as per Annex 16 to the EU Guide to Good Manufacturing Practice.
Key Responsibilities: You will support coach and mentor the QPs on site to support technical skills development.
Responsible for certifying Intermediate and API batches manufactured on site in compliance with the requirements of Annex 16 of the EU GMPs.
Lead Projects to ensure continuous development and maintenance of compliance to GDP; GMP; Marketing authorization; IMPD; Import License etc, depending on the product requirements.
Qualified Person representing the QP team at the site change control committee to ensure that any issues which have a regulatory impact are notified to health authorities and mitigated as required.
Attendance at the site Quality review meeting.
This meeting is a review of the quality system to determine its effective function and that improvement/remediation actions are taken as required.
You are site point of contact for quality department for intermediates outsourced to CMO's and the coordination of the release of intermediates for importation into the EU.
You will maintain oversight of issues/customer concerns related to batches post release ensuring that appropriate actions are taken as required.
Supports QA colleagues with product quality / license impact assessment for Quality IssueQualifications Education: You have fulfilled the educational requirements as outlined in Article 49 of Directive 2001/83/EC as an acting QP.
Experience and Skills: You have proven experience within regulated biologics / pharmaceutical industry within a cGMP manufacturing environment, with knowledge and proficiency batch release and compliance.
You have experience performing the duties of a Qualified person in a manufacturing facility.
You have gained experience in regulatory inspections in either hosting, presenting or defending site positions.
You have knowledge and experience in 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 Proficiencies Required: * Excellent interpersonal skills * Ability to operate as part of a team is essential.
* Attention to detail * Good problem solving skills * Strong decision making skills * Customer focus * Innovative * Collaborative * Excellent communication skills both written and verbal * Results and performance driven * Adaptable and flexible Other: Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.