NewsLooking for QA specialist

Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services. Currently, we are looking for a Quality Assurance Specialist to join our rapidly growing team in Lithuania. 

Main Tasks and Responsibilities 

  • Promote quality achievement and performance improvement throughout the organization. 
  • Develop and maintain a Quality Management System (QMS) at Insuvia in compliance with Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) guidelines, regulatory requirements, ISO 9001 and industry standards.
  • Create, review, and maintain QMS documents, such as the Quality Manual, Policies, Standard Operating Procedure (SOPs), Working Instructions, etc. 
  • Plan and execute internal audits and audits of Insuvia suppliers. 
  • Manage external audits and regulatory inspections including planning, hosting, report preparation, and release, responses to audit findings, follow up on audit responses. 
  • Write, review and track Deviation Reports, Corrective & Preventive Actions (CAPA), Change Controls. 
  • Coordinate in root cause analysis, impact assessment, corrective planning, follow up and trend analysis. 
  • Oversee the implementation of corrective and preventive actions plans (CAPA)review evidence to ensure that activities in CAPA have been implemented, evaluate CAPA effectiveness.  
  • Review of training requirements of staff, create and maintain internal training matricesannual training plans and follow-up on planned training to be completed on time. 
  • Coordinate, supervise, prepare and deliver required training for staff (staff onboarding, QMS training, SOP training, training on tools used within the company, training on regulatory requirements, etc.). 
  • Implement and maintain company’s electronic Learning Management System. 
  • Oversee Standard Operating Procedure (SOP) training compliance. 
  • Maintain and control the quality of staff training files and records (CVs, training plans and records, SOP training records, certificates, etc.). 
  • Gather customer satisfaction data and implement improvement activities. 
  • Select suppliers that comply with required standards, including supplier evaluation. 
  • Maintain QA trackers, folders and documentation, ensuring they are up-to-date and organized to ensure inspection ready. 

Download full job vacancy here: 2020.08 QA specialist

Please send your CV and short intro letter to [email protected]