Manager, GQP/Quality Assurance Group

Aug 09, 2021

Job Description

We are in important position to ensure stable and sustainable supply of good quality products from global / local manufacturing sites for our patient in Japan.  You will be an important gatekeeper to maintain the good quality pharmaceutical product, and also to improve the product quality to meet our customer expectation.

-Planning and supporting PQR/APQR activities -Support site qualification and validation activities (planning, advising, review)
-Implementation of Quality Systems (incl. documentation management)
-Supplier management activities (agreements, oversight, audit) -Preparation/support and coordination of CAPA/follow-up
-Audit and inspection preparation and support
-Change control review/approval
-Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc)
-Ensure process quality assurance acc. to regulations
-QP declaration review and approval -KPI trending
-Ensure applications, certificate maintenance etc. to local HA
-SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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Minimum Requirements

Novartis Technical Operations
Full Time

Manager, GQP/Quality Assurance Group

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