Quality Specialist, Pharmacovigilance
Labcorp Drug Development
Bucharest, Romania
4 zile în urmă
source : Pharmiweb

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.

  • 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*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*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.

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