Overview
Quality Assurance Assistant Jobs in Kaunas, Lithuania at Insuvia
Title: Quality Assurance Assistant
Company: Insuvia
Location: Kaunas, Lithuania
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.
We are looking for a Quality Assurance Assistant who will be responsible for providing administrative and technical support to the quality assurance department, ensuring the maintenance and continuous improvement of the Quality Management System and its processes throughout various means in line with the applicable standards and regulations, as well as assuring training compliance of all Insuvia HR.
Main Responsibilities:
Promote quality achievement and performance improvement throughout the organization.
Assist in developing and maintaining 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.
Provide support in creation, review, and maintenance of QMS documents, such as the Quality Manual, Policies, Standard Operating Procedure (SOPs), Working Instructions, etc.
Assist in writing, reviewing and tracking Deviation Reports, Corrective & Preventive Actions (CAPA), Change Controls.
Assist in coordinating root cause analysis, impact assessment, corrective planning, follow up and trend analysis.
Assist in overseeing implementation of corrective and preventive actions plans (CAPA), review evidence to ensure that activities in CAPA have been implemented, evaluate CAPA effectiveness.
Assist in reviewing of training requirements of staff, create and maintain internal training matrices, annual training plans and follow-up on planned training to be completed on time.
Assist in coordinating, supervising, preparing and delivering required training for staff (staff onboarding, QMS training, SOP training, training on tools used within the company, training on regulatory requirements, etc.).
Maintain and control the quality of staff training files and records (CVs, training plans and records, SOP training records, certificates, etc.).
Maintenance of electronic Learning Management System.
Oversee Standard Operating Procedure (SOP) training compliance.
Maintain QA trackers, folders and documentation, ensuring they are up-to-date and organized to ensure inspection ready.
Tracking/oversight of change controls, and archiving/documentation of change control records.
Ensure compliance with national and international standards and legislation.
Consider the application of environmental and health and safety standards.
Required experience, skills and competencies:
A bachelor’s degree or currently in the final year of university studies;
Advanced knowledge of MS Office (Word, PowerPoint, Excel);
Fluent command of English (written and oral);
Excellent organizational, time management, and communication skills;
Self-motivation, ability to assume responsibility and work autonomously in a professional manner.
Why join us
Learn from experienced professionals and grow into a PV project coordinator role.
Engaging, dynamic and diverse work in a young and rapidly growing company;
International and multicultural environment;
Real responsibility and meaningful tasks from day one;
Career path and training opportunities;
Supportive team and a friendly atmosphere;
Adequate workload, work-life balance and flexibility;
Modern office in the heart of Kaunas, incl. parking;
