Join Alfasigma as a QA GVP Specialist and play a key role in ensuring compliance with Good Pharmacovigilance Practices (GVP).
You'll be responsible for overseeing and enhancing the safety and quality systems, collaborating across departments, and supporting global pharmacovigilance efforts.
If you're passionate about patient safety and quality assurance, this is your opportunity to make a significant impact in a dynamic and growing industry.
Key resposibilities:
* Assist in ensuring compliance with GVP and regulatory requirements.
* Support the review and implementation of SOPs related to PV and QA PV.
* Help in conducting quality checks on PV reports and documentation.
* Help prepare for internal audits and regulatory inspections.
* Maintain audit-related documentation and follow up on CAPAs.
* Assist in monitoring timeliness and quality metrics for safety reports.
* Help track Key Performance Indicators for PV quality processes.
Specific Skills, Educational Requirements and Experience
* Minimum 1 Year of experience in the role.
* Ability to prioritize and to work with a sense of urgency.
* Attention to detail and ability to spot compliance issues ability to work according to procedures, rules and regulation.
* Master’s degree in a Scientific Field.
* Knowledge of GVP Regulations. Basic understanding of audit and CAPA processes.
* Knowledge of English (high level).
* Knowledge of Microsoft programs (Excel, Word, Visio, PowerPoint, Outlook).
Company:
Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals.