QA Specialist

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a QA Specialist to join our contingent workforce on a growing team in Janssen Pharmaceuticals in Cork. This will be an initial 12 month contract.

About Janssen Pharmaceuticals:

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.

The Role: 

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, C&Q and Validation activities, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements.

Key Responsibilities:

• 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.

Candidate Requirements:

• 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, HPRA, EMEA and other authorities.
• Experience in C&Q, and Process validation
• Experience in direct interactions with regulatory agencies during site inspections. 

If you meet our requirements and are interested in hearing more about our QA Specialist role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!