仕事内容
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.
Job Description
- Develop and execute the annual audit program dedicated to Galderma Pharmacovigilance systems, processes, and activities:
- Perform internal audits related to PV systems and processes,
- Conduct external audits (affiliates and external partners) of Galderma PV stakeholders,
- Perform PV subcontractor audits and periodically evaluate their quality level with regards to Galderma PV requirements and applicable regulations and coordinate the qualification of external PV partners e.g. through qualification questionnaire,
- Write Audit reports according to applicable procedures and review proposed Corrective and Preventive Actions as applicable,
- Perform peer review of PV QA audit reports.
- Ensure inspection readiness of the PV Quality Management System (Corporate, Affiliates and external partners when required) including preparation, support and follow up of inspections conducted by Competent Authorities
- Carry out independent review of PV documentation (including independent review of the PSMF)
- Contribute to the quality training of PV employees by developing training materials or facilitating training
- Author or provide input to PV Quality documentation, such as procedures, instructions, and forms
- Participate to the quality reviews of the PV quality system including the analysis of Key Performance Indicators to identify trends and signals
- Support Corporate PV in the investigation of deviations related to PV processes and provide quality input into the development of CAPA plans
- Ensure appropriate documentation of any non-compliance impacting the PV System in an electronic Quality Management System (Trackwise)
- Review and/or approve PV Quality documentation (compliance review)
- Foster a PV quality culture in Corporate and Affiliates organizations’ by providing advice from a PV quality perspective
- University Degree in Life Sciences with a background in Pharmacovigilance and Quality Assurance
- 6+ years of experience within the Pharmaceutical industry, from which a significant part in Pharmacovigilance or Pharmacovigilance Quality/Compliance function
- Experience conducting or hosting PV Audits or Inspections is desirable
- Ability to support international projects complying with quality requirements
- Knowledge of cGVP and global regulatory requirements
- Ability to work in a matrix organization with an exposure to cross-functional projects
- Proficient in QMS and Document Management Systems
- Medical Devices experience is a plus
- Team player with a collaborative attitude
- Excellent organization and time management skills
- Continuous improvements mindset – ability to propose improvements and new solutions
- Self-motivated and comfortable in fast-paced company environment
- Willingness to travel
- Fluency in English, written and spoken
締切: 04-05-2024
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