Role: QA Specialist
Location: Ringaskiddy Cork, Ireland
Reports to: Quality Team Leader
Janssen Sciences Ireland UC, (previously Janssen Biologics), is part of the Johnson & Johnson family of companies, the world’s most comprehensive and broadly-based manufacturer of healthcare products and related services. Our site in Ringaskiddy was established in 2005 on a 100-acre site with an investment of €500 million. We manufacture a range of biopharmaceutical products indicated for the treatment of conditions that include rheumatoid arthritis, psoriasis and cancer.
We are expanding our site to allow us to meet the critical needs of patients around the world. The expansion plans involve an investment of more than €300 million that will increase the existing manufacturing space by an additional 19,100m2, provide employment for up to 450 people during construction and an extra 200 people once completed.
We have an exciting opportunity for a QA Specialist to join our expanding team in Cork to help support the Quality Operations unit.
The QA Specialist will be responsible for the following.
Managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP). These activities include, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements.
You will have fulfilled the educational requirements for this role and have experience in a similar role within a FDA/EMEA regulated environment.
What you’re great at:
•Excellent interpersonal skills
•Ability to operate as part of a team is critical.
•Excellent communication skills both written and verbal
•Attention to detail
•Good problem solving skills
•Results and performance driven
•Adaptable and flexible
•Integrity, trustworthiness and objectivity
•Knowledgeable of FDA/EMEA regulatory requirements
As a QA Specialist, your typical day may include:
•Supports GMP activities from operational through to Laboratory support programs.
•Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
•Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
•Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.
• Participates as a key quality member in inspections and audits of JSCI by external parties/agencies.
•Key participant within the QA team in the execution of their duties.
•Executes the activities of the group within quality to create a synergistic approach to goals and tasks.
•Domestic and international travel may be required.
•To Bachelors Degree in a scientific/technical discipline required
•A minimum of 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry.
•Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
•Demonstrated knowledge and application of industry regulations including those of FDA, IMB, EMEA and other authorities.
•Focus on patients and customers at all times.
•Advanced degree (MS, MBA, PhD) preferred
•Experience in C&Q, and Process validation
•Experience in direct interactions with regulatory agencies during site inspections.
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
•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
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. 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.
Janssen R&D Ireland (7566)Job Function
Quality AssuranceRequisition ID