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Qa Specialist

1 week ago

Cork, Cork, Ireland 7566-Janssen Sciences Ireland Unlimited Company Legal Entity Full time

time left to apply End Date: March 28, days left to apply)
job requisition id R-002659
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 Job Function: Quality
Job Sub Function: Quality Assurance
Job Category: Professional
All Job Posting Locations: Cork, Cork, Ireland, 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 Johnson & Johnson Innovative Medicine 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.
GENERAL SCOPE OF 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.
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.Carries out tasks related to the administration of site supplier approval process.Key Skills and Competencies required: Excellent interpersonal skillsAbility to operate as part of a team is critical.Customer focusInnovativeExcellent communication skills both written and verbalAttention to detailGood problem solving skillsResults and performance drivenAdaptable and flexibleDecision makingQUALIFICATIONS AND EXPERIENCE: ESSENTIAL - Quality Assurance Specialist - QA Operations: Bachelors Degree in a scientific/technical discipline requiredA 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.About UsAt Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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

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