Johnson & Johnson Careers
Requisition ID: 1905741631W
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.
We have an exciting opportunity for a QA specialist to join our team in Cork. This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Pharmaceutical Sciences as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review, Product Quality Support and Validation compliance activities.
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
Key job responsibilities:
· Batch Record Review & material release to ensure compliance with GMP requirements.
· Carries out tasks related to the administration of event management systems including Review & Approval of Quality Investigations, Deviations, and Customer complaints.
· Carries out tasks related to the management of batch records design and approval.
· Carries out administration of the SAP Quality Management Module.
· Carries out tasks relating to the management of site change control systems.
· Compiles and Reviews Annual Product Review Reports and Continuous Process Verification reports.
· Supports all validation activities on site as described in the Site Validation Master Plan.
· Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
· Supports system qualification and process validation activities.
· Review and approve SOPs/work instructions/forms from other departments on behalf of Quality Assurance
· Co-ordinate and assist in the preparation for regulatory and customer GMP inspections of the site.
· Perform GMP audits on-site and vendor facilities as required.
· Carry out tasks related to the administration of site supplier approval process.
· Bachelor’s Degree in a scientific/technical discipline required – Level 8
· A minimum of 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
· Knowledgeable of FDA/HPRA 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.
· Focus on patients and customers at all times.
· Excellent interpersonal skills
· Ability to operate as part of a team is critical.
· Customer focus
· Excellent communication skills both written and verbal
· Attention to detail
· Good problem-solving skills
· Results and performance driven
· Adaptable and flexible
· Decision making
· Excellent time management skills with good multi-tasking ability
Janssen R&D Ireland (7566)