Quality Assurance Manager
B
BiomapasLife Sciences
Lithuania. Poland. Romania. Bulgaria. Croatia. Greece. Position is in Lithuania or any EU country.Full-TimeManager
Salary not disclosed
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Job Details
- Languages
- Professional level in English
- Experience
- At least 5 years of experience in a pharmacovigilance and/or clinical research environment
- Required Skills
- GCPQuality Assurance
Requirements
- Higher education in Life Sciences (e.g., Pharmacy, Medicine, Biology, Biotechnology).
- At least 5 years of experience in a pharmacovigilance and/or clinical research environment.
- Experience in quality assurance related to GVP and/or GCP activities.
- Knowledge of EU Good Pharmacovigilance Practices (GVP).
- Strong computer literacy.
- Experience with eLMS and eQMS programs.
- Ability to develop quality management systems and procedures.
- Professional level in English, both oral and written.
- Strong critical thinking and problem-solving skills.
- Excellent presentation, written and oral communication skills.
- Knowledge of GxP requirements is a plus.
- Knowledge of ISO 9001, ISO27001, and ISO13485 standards is a plus.
- Knowledge of Good Clinical Practice (GCP) is a plus.
Responsibilities
- Develop, review, and manage standard operating procedures (SOP’s) ensuring conformance with local and international requirements.
- Assure the effectiveness of the quality management system for clinical trials, pharmacovigilance, and regulatory affairs.
- Conduct GxP audits according to client agreements and internal programs.
- Manage vendors’ quality assessments and audits.
- Coordinate activities during regulatory GCP and GVP inspections and manage corrective/preventive action plans.
- Complete and manage quality management system documentation and accountability forms.
- Identify non-compliances, discuss audit findings, and provide recommendations for process improvement.
- Assist in root-cause analysis to identify effective corrective actions.
- Participate in staff training regarding quality and legal requirements.
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