We are seeking an experienced Senior QS Specialist to take a leading role in maintaining and improving our Quality Management System. You will drive quality initiatives, lead change control activities, ensure GMP compliance, support regulatory inspections, and contribute to the development of quality culture across the organization.
Responsibilities:
Lead and manage the Change Control system, including initiation, implementation, tracking, effectiveness review, and closure of change requests.
Ensure timely execution and follow-up of quality-related actions, CAPAs, deviations, and compliance initiatives.
Monitor project progress, quality risks, and issue resolution activities.
Facilitate communication between internal teams and external stakeholders.
Review and contribute to project schedules, timelines, validation activities, and risk assessments.
Escalate quality risks and critical compliance issues to management.
Prepare, review, and maintain GMP-compliant documentation and procedures.
Ensure company processes remain compliant with GMP requirements and internal SOPs.
Lead or coordinate internal audits and support external regulatory inspections.
Drive continuous improvement initiatives within Quality Systems.
Mentor and support junior QS team members, providing guidance on GMP and Quality System requirements.
Participate in supplier qualification and quality risk management activities.
Qualifications and Experience:
Master's degree in Biotechnology, Bioengineering, Biology, Biochemistry, Microbiology, Chemistry, Pharmacy, or a related field.
At least 3 years of experience in Quality Assurance or Quality Systems within a GMP-regulated environment.
Strong knowledge of GMP requirements and Quality Management Systems.
Experience managing Change Control, CAPA, Deviations, and audit activities.
Excellent problem-solving, project coordination, and communication skills.
Advanced computer literacy and proficiency in Microsoft Office applications.
Ability to independently plan, prioritize, and execute activities.
Fluency in Lithuanian and English.
Preferred Qualifications:
Experience with MasterControl or other eQMS systems.
Experience in Validation, Production, or Quality Control environments.
Experience supporting or participating in regulatory inspections.
Experience leading projects or mentoring colleagues.
Salary
€2,500–3,500 gross/month