Senior Audtior - Pharmacovigilance Auditing

Location

Bangalore | India

Job description

• We're seeking highly motivated and self-starting individuals to join our diverse and very engaged quality auditing team! We offer a quality auditing function, with good visibility into our Research & Development function and close interaction with various stakeholders

• In this role you lead, coordinate, and participate in the organization and execution of quality audits of different types (on-site or remote subsidiary/affiliate audits, vendor audits (providing GVP services), process audits and b usiness p artner audits) primarily in the pharmacovigilance area globally
• You perform data analytics during the preparation phase, prepare meaningful, standardized audit plans, create audit reports, and present audit observations and follow up on those
• Further, you will be taking over individual special projects to support the continuous improvement of the quality auditing function and to ensure audits are conducted consistently to high quality and in accordance with international and local Pharmacovigilance regulations and guidelines
• Furthermore, you might support the Inspection Management Team in preparation and hosting of inspections and inspection outcome follow-up

Who you are:

• Minimum 5-7 years QA experience or relevant experience in pharmaceutical and/ or biotech industry, in particular pharmacovigilance quality management, clinical quality management, biomedical science, clinical development, or regular compliance with a minimum of 5 years in Clinical Medical QA
• Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance and auditing skills covering a broad range of areas with focus on pharmacovigilance and preferable additional GxP areas, Medical Devices, Bioelectronics, Real World Data/Real World Evidence
• Working knowledge of GVP, GCP, ICH, US FDA and EMA regulations
• Strong ability to work in a structured way: good planning, project management and organization skills, track record of meeting milestone deliveries under tight deadlines and having a service-minded but goal-oriented mindset.
• Team player with very good intercultural and excellent communication skills; respectful interaction with auditees, independent, motivated, responsible approach to work
• User knowledge in PowerBI, MS Office 365, Veeva Vault QMS or similar software
• Excellent oral and written communication skills in English and ideally one other language (preferred Chinese, Japanese or Spanish)
• Willingness to travel globally (up to 15% travel time)

Job tags

Salary