Senior Audtior - Pharmacovigilance Auditing

Posted 10 Jan 2024

Bangalore, Karnataka - India

Req Id 269660

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Your role: 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 business partner 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)

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!


US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.


Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

Apply Now

Join our Talent Zone

You haven't found quite the right job yet? Join our Talent Zone and stay in touch with us. Be the first one to learn about our new career opportunities and events.

Tell us about yourself and let our Talent Advisors help you find your next career opportunity.