Quality and Compliance 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 Quality and Compliance Specialist to join our contingent workforce on a growing team in Janssen Pharmaceuticals in Cork. Initial contract to 31 DEC 2021 with further extension to 31 DEC 2022

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: 

Quality and Compliance specialist ensuring quality standards are achieved and maintained at suppliers through supporting management, and oversight on Quality Operations functions for external business partners. 

This support includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (EHS). Functions and activities include quality assurance review functions (such as Change Control, Quality Issue Management, compliance audit activities, supporting creation and management of risk mitigation plans for suppliers. 

Quality Specialist supports ensuring business, quality and compliance goals adhere to J&J policies, enterprise standards and government-issued environmental, health, safety, quality and regulatory policies and guidelines. Represents the JNJ credo and quality values in contact with the suppliers and will comply with the JNJ regulations for ethic and business conduct in order to strengthen the reputation of J&J.

This position requires the ability of building collaboration and teamwork across the local and global JSC organization, and it interfaces JSC ESI Quality with the quality unit of suppliers.

This position acts as a supporting role, supporting EQ SQ account owners and all qualification activities associated with Project Boost (Business Continuity Initiative).

Key Responsibilities:

• Support of planning, execution, and documentation of the qualification and monitoring for suppliers who are sourcing APIs, API materials or DP materials such as excipients, raw or packaging materials, to the Janssen Supply Chain for the manufacture of Intermediates, APIs, or drug products respectively.
• Support Surveillance on the quality and compliance status for all suppliers of raw materials, packaging materials, intermediates, excipients, and APIs.
• Support of Management of Change related to supplier (change assessor, action executioner,)
• Assessment of deviations, corrective and preventative actions (CAPAs), and complaints concerning materials received from suppliers
• Support Establishment of Quality requirements and Quality agreements.
• Support account owners for initial assessment and qualification of suppliers for new product introductions, and establishment of initial Qualification Statements.
• Support supplier Specification agreement and approval management
• In conjunction with Account owners he/she collaborates with internal operating companies and R&D partners on a wide variety of product, process, project and compliance related issues. Interfaces with internal JSC functional groups to broker the necessary technical support for external partners. Interactions are required with Tech Ops, PDMS, Procurement, EHS, Planning, the different JSC manufacturing sites, but also with the other quality groups within JSC and on enterprise level, such as Compliance, Quality unit API manufacturing, Quality systems and the different Qualified persons

Candidate Requirements:

• Bachelors Degree qualified or equivalent in a relevant discipline
• 1-3 years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment
• Familiar with GMP ? and International Conference on Harmonization (ICH) regulation
• Trackwise and SAP experience would be desirable
• Exposure to regulatory authorities inspections

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