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Sandoz

Quality Manager

Posted 10 Days Ago
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In-Office
Sandoz, CA
Mid level
In-Office
Sandoz, CA
Mid level
Oversee compliance in biopharmaceutical products, ensuring quality assurance protocols, regulatory adherence, and effective documentation management. Lead GxP training and process improvement initiatives while collaborating with cross-functional teams.
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Job Description Summary

Assurance that the product quality conforms with specifications and that production activity is compliant with Sandoz quality policy and GxP requirements. Ensure that relevant documentation is up-to-date and archived correctly. Ensure “state of the art” GxP know-how and future trends in the field of GxP  

Job Description

Your Key Responsibilities:

  • To ensure all quality assurance activities comply with the requirements of the Quality Manual of Procedures and internal SOPs of the company;

  • To implement appropriate SOPs;

  • To ensure that the Quality System and all Standard Operating Procedures are implemented and adhered to through training and internal audit;

  • To maintain knowledge of local and international, regulatory, legal requirements and trends for technical support on all aspects of quality;

  • To ensure that all activities related to "complaints", "recalls" are carried out in accordance with local legislation and Company Standards;

  • To monitor changes in local regulatory legislation and inform the relevant functional units;

  • To perform verification and translation of Certificates of Conformity and Certificates of Analysis of products upon request, maintains communication with authorized persons;

  • To maintain validity of GMP certificates of Company product manufacturers, apostilled and translated;

  • To provide assistance in inspections of foreign manufacturing sites by local regulatory authorities, interacts with internal functions when planning GMP inspections, as well as when performing job duties.

  • To support processes ensuring availability of Company products for distribution

Key performance indicators:

  • Local GMP/GDP Quality System in place and continuously updated, as required -GMP/GDP risks proactively identified and effectively mitigated.

What You’ll Bring To The Role

  • University degree;

  • Experience in the pharmaceutical industry (Registration, Quality Assurance, Manufacturing, Quality Control) not less than 2 years;

  • English upper Intermediate.

You’ll receive:
In addition to a market-competitive base salary, we offer an incentive program, limit on corporate mobile communication, lunch allowance, employee recognition scheme, learning and development options as well as worldwide career opportunities. Unleashing the potential of our people, we offer our corporate wellness program, which includes health & medical insurance, 28 days of annual leave, employee assistance program, parental or maternity leave, flexible working where possible

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, 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 is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

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.

Skills Desired

Change Control, Continued Learning, Dealing With Ambiguity, Guideline, Product Release, Qa (Quality Assurance), Quality Management, Regulation, Risk Management, Self-Awareness, Technological Expertise

Top Skills

Gxp
Quality Management Systems
Regulatory Compliance
Sops

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