QA Specialist

QA Specialist

Location: Cork

Duration: 12 Months

Hours: 39 months

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Johnson & Johnson Innovative Medicine (JJIM) as required by Good Manufacturing Practice (GMP).  

These activities include change control, nonconformance investigation, quality systems auditing, supplier qualification, documentation management, incoming materials release, batch release, annual product review and validation compliance activities at JJIM.

Roles and Responsibilities

• 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:

• Carries out tasks related to the administration of site nonconformance management systems:

• Carries out tasks related to the management of site change control systems

• Supports system qualification and process validation activities

• Carries out administration of the Supplier Assessment, Auditing and Inspection Readiness Systems at the site

• Supports GMP training activities

• Carries out tasks related to the administration of site supplier approval systems

• Carries out tasks related to the management of batch records design and release systems 

• Supports system process support validation and process validation activities

• Carries out administration of the SAP Quality Management Module for JJIM

• Reviews and approves SOPs/work instructions/forms/validation plans from other departments on behalf of Quality Assurance.

• Deputises for the Quality Assurance or Quality Systems Manager as appropriate.

How to Succeed

• Bachelors Degree in a scientific/technical discipline required

• A minimum of 2 years experience in a quality, manufacturing, validation or compliance role within the biological and/or pharmaceutical industry. 

• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.  

• Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, HPRA, EMEA and other authorities.

DESIRABLE:

• Experience in auditing of external suppliers, contractors and vendors.

• Experience in development/and or evolution of GMP systems and/or start up experience highly desirable.

Benefits

This role offers a very competitive hourly rate. This contract will run for 12 months.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

Application Process

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

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

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 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”.