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Quality Specialist, Pharmacovigilance

Employer
Labcorp
Location
Bucharest, Romania
Salary
Competitive
Start date
25 Jun 2022
Closing date
23 Jul 2022

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Due to continuous growth and demand we are hiring a Quality Assurance Specialist to work closely with QA Management, internal/external clients and vendors or suppliers of Labcorp. You will a ssume responsibility for ensuring quality for the assigned Pharmacovigilance projects; contribute to process improvement, training and audit readiness.

Language Skills Required:
  • Speaking: Fluency in English and local language plus ideally one of the following; German, French, Portuguese or Swedish.
  • Writing/Reading: English and local language as well as either of the above.


Responsibilities
  • Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
  • Ensure compliance of operations with governing regulatory requirements
  • Perform Quality review of assigned cases
  • Assist in compiling quality metrics based on this review and identifying quality trends
  • Assist in addressing periodic client quality reviews
  • Assist in preparation of Corrective and preventive actions as requested
  • Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers
  • Assist in the conduct of process review for assigned process and measure and monitor audit readiness
  • Assist in designing and tracking training schedule and training material for new hires and existing team.
  • Contribute to discussion forums on Quality errors within assigned project and help identify process improvements
  • Assist in coordinating respective client or external audits of the assigned projects as requested
  • Assist in development of Quality Management Plan for assigned project
  • Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager


Qualifications
  • Bachelors/Masters degree in Medicine or Alternative medicine or Pharmaceutical science
  • 2 plus years of overall work experience in the functional area with one year in Peer review/Quality review Special Skills & Knowledge
  • Pharmacovigilance
  • Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines
  • In-depth understanding of case processing and assessment
  • Technical proficiency with Microsoft Office suite of applications Key Competencies
  • Good verbal and written communication skills


Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement .

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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