Quality Assurance Specialist

2 days ago

Bengaluru, Karnataka, India beBeePharmaceutical Full time ₹ 14,40,000 - ₹ 18,30,000
Job Overview

We are seeking a Quality Assurance Professional who will provide quality of service to clients in a safe and cost-effective manner.

Responsibilities
  • Taking ownership of assigned aspects of quality reviews on projects.
  • Compiling metrics and identifying quality trends.
  • Assisting in addressing periodic client quality reviews and other ad-hoc client quality findings.

Additonal responsibilities include:

  • Preparing initial drafts of corrective and preventive actions.
  • Performing ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents.
  • Assisting with the overall functional quality operations associated with products including the entire adverse events process.
Key Responsibilities Include
  • Managing and reviewing expeditable adverse events, product quality complaints and medical information to the required standard and submitting them to the client and the regulatory agencies within agreed timelines.
  • Taking ownership of assigned CAPAs with respect to ensuring that the actions are closed and producing documentary evidence to that effect in coordination with project managers.

The ideal candidate will also contribute to process reviews, own certain aspects of the reviews and use the results to help identify process improvements and develop process standards. They will also assist in coordinating respective client or external audits of assigned projects, draft sections of the Quality Management Plan for assigned project and coordinate with the project team to support the Client during regulatory inspections at client sites.

Requirements
  • Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences or related area.
  • Three years of overall work experience in the pharmaceutical industry, biotechnology or CRO industry primarily in Pharmacovigilance / Safety writing with at least One year of experience in Peer review/Quality review.

Preferred qualifications include experience in generating quality metrics with trend analysis, authoring and coordinating Corrective and Preventive Action Reports and assessing quality of a case/safety report from a medical, scientific and documentation perspective.

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