Quality Assurance Consultant, PV Support
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Job Description
Quality Assurance Consultant providing operational QA and Pharmacovigilance support for a global pharmaceutical company. Responsibilities include handling quality deviations, training, and compliance management.
Responsibilities:
- Operational handling of quality deviations, incidents and complaints, including root cause analysis and CAPA activities, and support in change control when required
- Update, maintenance and lifecycle management of SOPs and support in KPI follow up and Quality Management Review activities
- Administrative handling of Pharmacovigilance activities, including intake and registration of adverse event reports, creation of case files, documentation archiving and logging in local tracking tools
- Preparation of monthly reports within QA, PV and medical topics, and coordination with external PV partners and systems
- Distribution and archiving of updated SmPC and PIL documentation, as well as support in regulatory intelligence monitoring
- Registration and follow up of training activities and training records
Requirements:
- Experience from operational Quality Assurance work within pharmaceutical and or medical device organizations
- Good working knowledge of GMP, GDP, GVP and relevant EU regulatory requirements
- Exposure to Pharmacovigilance processes, particularly administrative case handling, is an advantage
- Ability to work independently, structured and confidently with time critical tasks
- Fluency in Swedish and very good English skills, written and spoken
Benefits:
- Opportunities for personal and professional growth
- Collaborative team environment
- Focus on quality and making a difference in patients' lives
- Core values of Trust, Quality, Passion, Flexibility, and Sustainability
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