Description
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 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:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Ringaskiddy, Cork, IrelandJob Description:
Position Summary:
This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Sciences Ireland 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.
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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 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- Quality Assurance Specialist-QA Operations:
achelors 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.
Required Skills:
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality StandardsThe anticipated base pay range for this position is:
€52 400,00 - €82 915,00Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
