QA Specialist

QA Specialist

Location: Ringaskiddy, Cork

Duration: 12 months

Hours: 39 hours per week

Pay rate range: Competitive hourly rate

Variety of QA roles - Batch Records, Product Quality Support and QA Projects

2+ years’ experience with QA pharma preferable but 5+years with QC pharma/QA Medtech/highly regulated industry also an option

We are particularly interested in candidates with a pharmacy degree or pharmacists without industry experience who are looking to get industry experience

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Biologics as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities.

Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.

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 behaviour model.

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

duties:

• Batch Record Review & material release to ensure compliance with GMP requirements.

• Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.

• Carries out tasks related to the management of batch records design and approval.

• Carries out administration of the SAP Quality Management Module.

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

• Compiles Annual Product Reviews.

• Supports all validation activities on site as described in the Site Validation Master Plan.

• Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).

• Supports system qualification and process validation activities.

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

• Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.

• Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)

• Perform GMP audits on-site and vendor facilities as required.

• Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards.

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

how to succeed

• 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

• Decision making

qualifications and experience:

essential:

• Bachelors Degree in a scientific/technical discipline required

• A minimum of 3-5 years’ experience in a quality, 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, IMB, EMEA and other authorities.

desirable:

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

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

• These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities.

• Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.

benefits

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

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”.