Gmp Auditors

7 months ago

Navi Mumbai, 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 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.

Ensure alignment with strategic direction of the company and assist in driving implementation of the applicable actions. Provide consultation to Sandoz business units through risk based assessments. Act as SME for assigned areas of responsibility.

Your Key Responsibilities:
Your responsibilities include, but not limited to:

- Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
- Plan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Sandoz Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
- For this role, auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess risk of these operations is critical to success.
- Provide technical guidance, mentoring, and training on audit activities. Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing. Prepare audit reports according to Sandoz requirements and time-lines.
- Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to 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.
- Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed. Assure permanent transfer of best practice identified during the audit into Sandoz QMS system
- Review and advise on relevant policies and procedures. Mentor junior GMP staff as required. Maintain current knowledge of regulations, standards, and guidance documents. Identify and report best practices and lessons learned to support development / training of GMP auditors.

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 with min 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 requirements.
- Willingness to travel approximately 60% of the time.
- Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
- Experience and/or interaction with local Health Authority and sporadically with other Health Authorities.
- Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers.
- Ability to independently manage and objectively evaluate complex compliance issues with mínimal supervision
- Excellent leadership and facilitation skills.

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 ha

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