Pqv Combo Products Analyst 2, Cork, Johnson & Johnson

Ireland, Cork
Published 2022-09-24
Expires 2022-10-24
ID #1181967610
Pqv Combo Products Analyst 2, Cork, Johnson & Johnson
Ireland, Cork,
Published September 24, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Pqv combo products analyst 2

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Job title PQV Combo Product Analyst 2
GCF 24
Location Cork, Beerse or Schaffhausen
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 in Janssen are 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.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
About this role:
The position collaborates with business partners and stakeholders (Out Sourced Management Team, External Manufacturing Sites, Internal/External Manufacturing Sites, Clinical, PV, IT, Local Operating Companies, ESIQ, Call Centers, Brand Protection, QA, Business Quality, Medical Safety and R&D) to deliver effective product complaint processing.
The Analyst II must have the ability to support various projects leads within the department and communicate effectively will all levels of management.
Key Responsibilities:
Perform end-to-end complaint handling activities, including but not limited to Intake, triaging, recovery of field samples for evaluation due diligence will be performed with complainant/intake centers/LOCs), trend analysis, defect coding, risk criticality assessment, ensuring accurate/holistic investigation, and review and closure.
Ensure that uniform and timely management of complaint records from receipt to closure, and investigations are accurately assessed for risk prioritization and performed per procedures, standards and regulations.
Compile and analyze data, metrics and trends associated with complaint handling processes.
Back-up other E2E (PQV Combo) to support increased volume of complaints.
Ability to allocate and balance competing priorities in driving business results.
Participates special projects.
Support the development and deliver training for colleagues and stakeholders on complaint handling process, product specific training, and complaint handling system updates/changes.
Evaluate and review compliant data trends, KPI trends and product report trends.
Support the PQV group with the development, revision and / or maintenance of applicable documents (WI/Job Aids/SOPs.
Experience, skills & proficiencies required:
1-5 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry.
Knowledge of medical safety environment and regulation.
Global mindset and demonstrated ability for change initiatives, project management and develop strong relationships
Working knowledge of and experience with the following regulatory requirements: 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ISO 13485:2003, ISO 14971:2007/2012, ICH Q10, GDP, GMP, GVP, MEDEV 2.12, CMDR and the Medical Device Directive 93/42/EEC
Bachelor’s degree or master’s degree (preferred) in technical, scientific, or engineering disciplines required. Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.
Location of Role: EMEA
Travel Requirements: This position may require up to 5-10% travel domestically and internationally.
Environmental Requirements: It is required for the incumbent to follow all safety procedures to minimize health hazards.
Physical/Work Requirements: Working at a computer for extended periods of time. Working independently in a global team. Ability to attend virtual meetings during off-business hours and work outside of normal working hours when needed.
Closing date 28th August 2022
What type of mark will YOU make?
By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work with us you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.
What’s in it for YOU?
It’s vital to us that you feel you can bring your whole self to work; at J&J we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive wage and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples of this include: online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme.
Primary Location
Janssen R&D Ireland (7566)
Job Function
Requisition ID

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    Manufacturing is the production of merchandise for use or sale using labour and machines, tools, chemical and biological processing, or formulation. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be sold to other manufacturers for the production of other, more complex products, such as aircraft, household appliances, furniture, sports equipment or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users and consumers.

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