Global Gmp Auditor

2 weeks ago

Mumbai, Maharashtra, India Sdz Pvt Ind Full time
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of

sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater

agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the

Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will

provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our 'new' Sandoz

Position Purpose:


Lead, support and report independent GMP audits according to the Novartis/ Sandoz Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.

Review and approve corrective action plans in support of the audit observations.

The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.


Your Key Responsibilities:

Your responsibilities include, but not limited to:

  • Plan, lead, conduct, document, report, and follow-up of GMP audits according to the requirements specified in the respective Novartis/ Sandoz procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
  • Audits will be focused to midlow risk manufacturing and other GMP activities, on the basis of actual experience/expertise
  • Provide technical guidance and training on audit activities.
  • Ensure appropriate escalation to responsible management in case of critical findings and support immediate followup measures according to Novartis/ Sandoz requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
  • Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
  • Maintain current knowledge of regulations, standards, and guidance documents.
Diversity and Inclusion

  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Minimum Requirements

What you'll bring to the role:

  • Degree in Chemistry, Pharmacy, Biology, Engineering or another related science degrees with relevant experience may be accepted
  • Excellent oral and written English communication skills

Preferable:
Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is preferred

  • At least 10 years broad experience in Pharmaceutical or Medical Device Industry.
  • The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.
  • 3 years auditing experience preferred, and excellent knowledge of regulatory.
Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in

this sector, touched the lives of almost 500 million patients last year and while we are proud of this

achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and

partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to

low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our

environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth

is encouraged

The future is ours to shape

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams

representative of the patients and communities we serve.

Join our Sandoz Network:
If this role is not suitable to your experience or career goals but you wish to

stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz

Sandoz

  • Division
  • SANDOZ
  • Business Unit
  • Quality STO
  • Location
  • India
  • Site
  • Mumbai
  • Company/Legal Entity
  • Sdz Pvt Ind
  • Functional Area
  • Quality
  • Job Type
  • Full Time
  • Employment Type
  • Regular
  • Shift Work
  • No

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