29 ago
|
Sandoz Iberia
|
Madrid
29 ago
Sandoz Iberia
Madrid
At Sandoz, our goal is not just to increase access, but to do so in a sustainable and responsible way:
finding the right balance between guaranteed quality, reliable supply and appropriate pricing. Our aim is to excel at all three, ensuring we never compromise on quality.
to protect our environment (carbon footprint, natural resources), as well as to champion diversity, equity and inclusion across our company and beyond
As GMP Senior Auditor you'll 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 Responsibilities Will Include
Support the strategic development of an effective general 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 acce
📌 Global Senior GMP Auditor (Madrid)
🏢 Sandoz Iberia
📍 Madrid