Pharmacovigilance QA EMEA Auditor
Share
Job Location:
High Wycombe - UK
Monthly Salary:
Not Disclosed
Posted on:
23 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
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 & Compliance AuditJob Category:
ProfessionalAll Job Posting Locations:
High Wycombe Buckinghamshire United KingdomJob 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 we are uniquely positioned to innovate across full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
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 individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every
step of the way.
Learn more at OverviewJohnson & Johnson IM is currently recruiting for a Pharmacovigilance QA Auditor Specialist.
As a Pharmacovigilance QA EMEA Auditor Specialist you will be part of a dynamic global team working to enhance quality across the Company through pharmacovigilance audit and business partner collaboration.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):
Italy Belgium France Spain - Requisition Number: R-075343
Switzerland - Requisition Number: R-075300
UK - Requisition Number: R-075343
Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.
Key Responsibilities:
Auditing
Leads the planning conduct and reporting of Pharmacovigilance routine audits
Supports non-routine Pharmacovigilance audits of activities data internal facilities and processes in GxP areas
Project Management
Participates in projects or serves on teams as assigned by supervisor.
Inspection Support
Supports regulatory inspections in various supporting roles.
Training & Development
May assist in the preparation of training material if requested.
Subject Matter Expert / Point of Contact
Provides consultation to business partners on routine tasks with occasional supervision.
Cooperates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.
Qualifications
Education:
Bachelors or equivalent University degree required; Focused degree in natural/biological sciences or equivalent
Experience and Skills:
Required:
A Minimum Bachelors or equivalent University degree required; Focused degree in natural/biological sciences or equivalent
Strong verbal and written communication skills including presentation skills
Strong teamwork and analytical skills
Ability to work effectively as part of a collaborative team
Fluency in English
Preferred:
Minimum of 2 years experience in a GVP-regulated environment is preferred with demonstrated exposure to Pharmacovigilance activities.
Other:
This position requires 10%-30% domestic and international travel
Italy Belgium France Spain - Requisition Number: R-075343
Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.
Leads the planning conduct and reporting of Pharmacovigilance routine audits
Supports non-routine Pharmacovigilance audits of activities data internal facilities and processes in GxP areas
Participates in projects or serves on teams as assigned by supervisor.
Supports regulatory inspections in various supporting roles.
May assist in the preparation of training material if requested.
Provides consultation to business partners on routine tasks with occasional supervision.
Cooperates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.
A Minimum Bachelors or equivalent University degree required; Focused degree in natural/biological sciences or equivalent
Strong verbal and written communication skills including presentation skills
Strong teamwork and analytical skills
Ability to work effectively as part of a collaborative team
Fluency in English
Minimum of 2 years experience in a GVP-regulated environment is preferred with demonstrated exposure to Pharmacovigilance activities.
This position requires 10%-30% domestic and international travel
Required Skills:
Preferred Skills:
Agile Internal Audit Analytical Reasoning Audit and Compliance Trends Audit Reporting Business Behavior Compliance Management Compliance Policies Compliance Risk Critical Thinking Detail-Oriented Problem Solving Quality Control (QC) Quality Standards Regulatory EnvironmentRequired Experience:
IC
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
