Specialist Quality Operation at SANDOZ INC

, , India -

Full Time

Start Date

Immediate

Expiry Date

06 Apr, 26

Salary

0.0

Posted On

06 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa, Quality Assurance, Quality Control, Qc Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Industry

Pharmaceutical Manufacturing

Description

Job Description Summary Job Description Summary Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Sandoz Quality Management Systems. Job Description Your Key Responsibilities: Your responsibilities include, but not limited to: Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt Distribution of marketing samples (where applicable) What you’ll bring to the role: Functional Breadth. Minimum 8+ years of relevant experience. QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & collaborating across boundaries. 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 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 encouraged! The future is ours to shape! Skills Desired Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!

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Responsibilities

The Specialist Quality Operation manages quality aspects and projects, ensuring compliance with GxP and Sandoz Quality Management Systems. Responsibilities include oversight of production and testing activities, exception investigations, and batch release execution.