Quality Assurance Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Main responsibility:

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Pharmaceutical Sciences as required by GMP. These activities include incoming materials release, batch review and release, nonconformance investigation, change control, documentation management, validation compliance activities etc.

Duties and responsibilities:

• Responsible for executing tasks related to the management of batch records and release processes.
• Responsible for performing tasks related to the completion of nonconformance investigations and site change controls.
• Responsible for supporting and participating in audit activities (HPRA, JJRC, PRC, Customer etc).
• Provides support and direction to all Departments to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behaviour model.
• Partners with other departments to ensure that GMP compliance systems are implemented and aligned with JSC Quality Policies, Guidelines, Programs and Systems.

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