QA Data Specialist

Position Title: QA Data Specialist

Location: Janssen, Ringaskiddy

Closing Date: 14th October

Johnson & Johnson Innovative Medicine Ringaskiddy are recruiting for a Facilities Manager.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where sophisticated 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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to build a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver significant solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we cultivate a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.

At Johnson & Johnson, we all belong.

Job Purpose:

Quality Assurance Data Specialist is responsible for carrying out tasks and projects related to Data Visualisation & Data Governance within the Quality department at J&J Innovative Medicine as the need arises by Good Manufacturing Practice (GMP).

The successful candidate will be responsible for QA data system administration, design and continuous improvement implementation at J&J IM.

What you’re phenomenal at:

• Innovative with strong decision-making and problem-solving skills.
• Ability to work individually or collaborate with cross-functional teams, as required.
• Excellent communication and influencing skills, strong customer focus.
• An understanding of data integrity requirements for the pharmaceutical industry.

Responsibilities:

• Support GMP activities and provide oversight for processes relating to batch manufacture and release within the manufacturing facility.
• Provide GMP oversight and support to Automation processes, dashboards and solutions to assess compliance to Global and regulatory requirements.
• Accountable for Quality oversight of processes and procedures related to Data integrity, Computerised Systems & Automation compliance.
• Partner with Automation CSV, Engineering and Quality Control to ensure site procedures for computerized systems, data integrity and automation activities are in compliance with current standards.
• Provide Quality and cGMP input and oversight for all Data Management and Data Integrity activities.
• Provide support in the use of business tools such as SMART QA and lead improvements to ensure these tools are being used in a compliant manner.
• Lead the compliance activities to sustain and improve sophisticated workflows and Tableau visualisations.
• Interrogate data analysis results and write technical summaries to support product quality and safety related discussions.
• Connect with customers to develop an understanding of GMP standards as they apply to data analytics and ensure compliance and validation activities are included in project timelines.

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