Qualified Person (Maternity Backfill)

Job description

Role: Qualified Person – FTC (12 months)
Location: Ringaskiddy Cork, Ireland
Reports to: QA Manager
Band: 26

Description

Janssen Sciences Ireland UC established its operation in Ringaskiddy in 2005 on a 100 acre site with an investment of €500 million. For more than 25 years we have been a global leader in the field of biomedicines, in particular pioneering monoclonal antibody technology a cutting-edge approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The facility in Ringaskiddy is operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments.
In 2017, Janssen Sciences Ireland UC announced that it is to invest more than €300 million in the expansion of its manufacturing plant that will create more than 200 new jobs.

Job Purpose

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

What you're great at:

As a QP, your typical day may include:

-Responsible for certifying DSP batches prior to release to filling site
-Ensure that the batch and it's manufacture comply with GDP; GMP;
Marketing authorization; IMPD; Import Licence etc, depending on the product
requirements
-Maintain oversight of deviations (Quality Investigations) 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 authorised 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
deviations.

Desired profile

Qualifications :

Be vital:
To be part of this high performing team you will have great attention to detail, alongside:

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
-Maintains focus on patients and customers at all times
-Maintains the highest standards of ethical behaviour

ESSENTIAL:

-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.

What we're about:

We are passionate about our work, and 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. We share a kind of DNA where we're each:
•Committed to caring
•Responsible to our communities
•Ready to apply our knowledge and know-how
•Rare in our background and experiences
•The drivers of our own success
•Passionate about doing what's right

Make a unique mark in your career

If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your real passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.