Commercial (Health) Senior Associate - England, United Kingdom - Johnson & Johnson

Description

Job Description - Commercial Quality Senior Associate W)
Commercial Quality Senior Associate W
At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

J&J Innovative Medicine is recruiting for a Commercial Quality Senior Associate to be located in UK.

The Commercial Quality Senior Associate works in the Commercial Quality Team UK and Ireland, which is part of the EMEA Commercial Quality Organisation.

We are looking for an experienced Senior QMS Associate to join our team on a permanent basis reporting into the Quality Head 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.

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
• 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.
Lifecycle management of GMP/GDP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity
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.
Assist in the management and follow-up services for local authority inspections. Support and conduct local internal and external quality audits.
Quality activities

Monitor the Quality System performance versus local GxP and J&J requirements via use of pertinent business and compliance metrics and goals.

Support the Quality Head with monitoring and oversight of compilation of metrics where required. Provide input to the Quality Head 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.

Drive / participate to local / regional / Global projects
Professional Development

Training Record maintenance; Internal:
All Company functions, Local/EMEA/Global Quality organizations, Functional stakeholders as required

External:
Health Authorities, Home Office, External Certification Bodies as required
Life science degree or pharmacy technician qualification or equivalent qualification / experience in pharmaceutical regulations and processes.
Ability to apply GMP and GDP regulations and international guidelines to all aspects of the position and experience with external regulatory bodies

• Self starter, ability to interpret data and present outcomes
• Strong technical writing, verbal communication, and problem-solving skills
• Quality Systems experience or other relevant experience including Quality Compliance.
• Computer literate with expert knowledge of Quality database systems
• Up to date knowledge of relevant pharmaceutical legislation and GMP/GDP. 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.

Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"

All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check ourpage for information on how to request an accommodation.
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