Job Information
J&J Family of Companies Commercial Quality Associate in England, United Kingdom
Commercial Quality Associate - 2406184241W
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 https://www.jnj.com/
J&J Innovative Medicine is recruiting for a Commercial Quality Associate to be located in UK.
The Commercial Quality Associate works in the Commercial Quality Team based in the UK, which is part of the EMEA Commercial Quality Organisation. We are looking for a Quality Associate to join our team on a permanent basis reporting into the Quality Manager UK. Working closely in a pro-active team you will support the Company in ensuring the highest standards of Quality Assurance and Compliance to Pharmaceutical regulations.
Duties and responsibilities
Pharmaceutical Environment’s Regulations
Compliance with pharmaceutical sector legislation for all the technical-administrative activities of the company
Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP requirements for UK and Ireland
Implementing and verifying the technical-administrative completeness of documentation
Key Responsibilities
Quality Management
Support the business units in terms of quality management and the resolution and communication of non-conformances. Maintain and implement the Quality system. Collaborate with internal and external partners to provide input to new projects and concepts
Procedures
Ensure procedures are adhered to and ensure they are in line with local regulations
Inspections / Audits
Assist in and support local authority inspections and internal audits
Quality activities
Support in the end-to-end management of Product Quality Complaints and distribution/delivery service issues. Ensure GDP regulations are adhered to and investigate any non-conformances. Monitor the Quality System performance versus local GxP and J&J requirements. Ensure appropriate management of the preparation, execution and follow up of non-conformances and CAPAs related to GxP. Provide input to the Quality Manager for the bi-annual Quality System Management Review for CQ
Training
Support the continuous training programs ensuring they are maintained to guarantee appropriate competence and experience as well as knowledge of and training in GDP for the team and internal partners.
Continuous Improvement / Projects
Drive continuous improvement for the processes accountable for
Lead / participate to local projects
Professional Development
Training Record maintenance; constant update on legislations and Company’s requirements
Relations
Internal: All Company functions, EMEA/Global Quality organisations
External: Health Authorities, and External Certification Bodies
Qualifications
University Degree in Pharmacy, Biology, Chemistry or related Life Science is preferred element
External Body Qualification as Internal Auditor
Excellent knowledge of English language
Knowledge of Microsoft Office
Knowledge of Local UK and Ireland regulations, as well as related J&J policies
Monitoring process efficiencies across the operating company by measuring KPIs and planning actions for improvement for Process excellence
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 UK 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”!
Primary Location Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization Janssen Cilag Ltd. (7360)
Job Function Quality Assurance
Req ID: 2406184241W