QA Shift Specialist

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Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Ringaskiddy, Cork, Ireland

Job Description:

POSITION SUMMARY:

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Sciences Ireland (JSI) UC as required by Good Manufacturing Practice (GMP).

These activities include, but are not limited to, operations on the floor support, change control, nonconformance investigation, quality systems auditing, supplier qualification, documentation management, incoming materials release, batch release, and annual product review and validation compliance activities at JSI.

NOTE: This role is 100% on-site.

No hybrid working is available for this role.

This is a shift role (2-Cycle) working 09:00-20:00 Weekdays and 07:00-18:00 Weekends.

There is a shift allowance of 20% applied.

GENERAL SCOPE OF RESPONSIBILITIES:


* Provide routine QA presence in manufacturing areas during operations (50% of role) including:


* Ensure manufacturing activities are conducted in compliance with GMP requirements, site procedures, and regulatory expectations.


* Perform GMP walkdowns and ensure compliance with approved procedures and quality standards.


* Provide independent quality decision-making to support compliant production.


* Ensure manufacturing areas are in an audit-ready state


* Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.

Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.


* Supports the development and management of GMP compliance systems through the following activities:


* Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.

Assesses compliance systems on ongoing basis to identify opportunities for process improvement.

Carries out tasks related to the administration of site nonco...