348820BR
Jul 15, 2022
Japan

Job Description

Job Purpose:
-Supports effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators).
-Supports the preparation and management of external and corporate audits and Health Authority inspections.

Major Accountabilities:
-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 & 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 & 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!

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones English Knowledge of GMP Knowledge of IT Applications & tools Knowledge of Core work processes Quality Standards Quality Assurance
Novartis Technical Operations
NTO QUALITY
Japan
Tokyo
Quality
Full Time
Regular
No
careers default image
348820BR

Associate, QA Compliance

Apply to Job Access Job Account