Quality Engineer

Quality Engineer

Location: Full time on site - Cork

Duration: 12 months

Hours: 39 per week

This position is responsible for managing compliance activities related to Make Asset Management (MAM) within Janssen Sciences Ireland (JSI) UC as required by Good Manufacturing Practice (GMP). These activities include executive roles in managing change control, non-conformance investigations, compliance auditing, and other related quality system elements.

roles and responsibilities

• Provides leadership and direction to the MAM team in respect of specific quality system and or quality operation elements to ensure business, quality and

compliance goals are met.

• Provides leadership in the development and management of Quality through the following actions:

o Supports the Quality Engineering team in coaching and mentoring the MAM team to ensure GMP compliance goals are achieved.

o Partners with other Departments to ensure that non-conformances and Change Controls are completed in an efficient manner.

o In conjunction with the Quality Engineering Team and QA develop and implement systems and procedures for the management of non-conformance investigations as they apply MAM activities. Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate. Tracks commitments arising from investigations.

o Through personal expertise, leadership and commitment, provides direction to the MAM team in the development of a culture of quality and compliance.

Key competencies required

• Excellent interpersonal skills.

• Ability to operate as part of a team is critical.

• Customer focus.

• Innovative.

• Excellent communication skills both written and verbal.

• Attention to detail.

• Good problem solving skills.

• Results and performance driven.

• Adaptable and flexible.

Qualification and experience:

Essential 

• Bachelor’s degree in a scientific/technical discipline required.

• A minimum of 5 years’ experience in a quality 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 including those of FDA, HPRA, EMEA and other authorities.

Significant Safety or Working Considerations:

All employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS procedures, local legislation and duties outlined in the site EHS Manual.

In line with the Safety Health & Welfare at Work Act (2005), all employees are required to:

• Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.

• Comply with EHS rules and procedures at all times.

• Understand the potential EHS impact of their activities.

• Attend and participate in EHS training as required.

• Use PPE and safety equipment as required.

• Report all incidents, accidents, and near miss events.

• Report unsafe plant, equipment, acts, procedures or issues.

• Make suggestions to improve health and safety in the workplace.

• Actively participate in work area EHS teams.

• Not turn a ‘blind eye’ to unsafe acts or situations.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

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 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. 

questions

If you would like some additional information about the role please contact: Tabitha.Crabtree@randstadsourceright.co.uk

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”.