Quality Data Specialist

Position: Quality Data Specialist

Location: Barnahely, Cork

Work type: Hybrid - 3 days on site, 2 remote

Start date: As soon as possible

Contract duration: 12 month 

Hours: 39 hours a week

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Key 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 computerised 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 for the business using tools to ensure completion in a compliant manner.

• Lead the compliance activities to sustain and improve complex workflows and Tableau visualisations.

• Interrogate data analysis results and write technical summaries to support product quality and safety related discussions. 

• Communicate 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.

Competencies: 

• 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.

Requirements:

• Third level degree in Engineering, Science, or an IT discipline.

• Minimum of three years’ experience within a pharmaceutical or GMP regulated manufacturing environment is desirable 

• Ability to work individually or collaborate with cross-functional teams, as required.

• Familiarity with SIMCA, Tableau, Python, R studio is desirable.

In return for this role, you will receive a competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader with Johnson & Johnson.

Things to remember before applying for this role:

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email.

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.

Thank you very much and we look forward to receiving your application.