Quality Assurance Lead

1 week ago


Ho Chi Minh City, Ho Chi Minh, Vietnam Novartis Argentina Full time

Job ID BR- Feb 17, 2023- Vietnam
Job Description:


  • 1886 We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in Generics and Biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
  • As Quality Assurance Lead, you ensure all qualityrelevant processes within the Country Organization are compliant and that noncompliance is appropriately addressed via corrective and preventive actions (CAPA) and/or escalation of issues. You provide Quality oversight and governance to ensure proactive compliance with Sandoz and Health Authority GxP requirements, and to meet business expectations. Prevent quality or regulatory noncompliance issues which could lead to product stockout or withdrawal, product approval delays or which would negatively impact the financial performance of the company, as well as the company reputation. You drive process standardization and efficiency gains through innovation and operational
- excellence projects

Your Responsibilities:

Your responsibilities include, but not limited to:

  • Lead the development of Quality Culture with high awareness on data integrity and close collaboration with Vietnam business partners to best support overall business strategy.
  • Establish effective Quality oversight and ensure Quality Plan is implemented in the Vietnam Country Organization (namely for commercial batch release in compliance with Marketing Authorization, effective change control management, effective complaint management, effective risk assessment, effective Quality oversight for pharmacovigilance processes).
  • Act as the company key point of contact for Health Authority Field Alert and drug shortage reporting for pharmaceutical products and thereby provide a link between supplying sites and the agency.
  • Establish regular review and assessment of KQIs at the Vietnam Quality Committee.
  • Lead the implementation of applicable Quality Standards and effective CAPA processes and ensure compliance with escalation processes in the Vietnam Country Organization.
  • Ensure that relevant SOPs are aligned to HA regulatory requirements.
  • Deliver successful GxP regulatory inspections and internal audits of the Vietnam Country Organization.
  • Continuously engage in benchmarking with other industries, industry peers and actively engage across Countries in building proactive relationships with Health Authorities.
  • Ensure timely delivery of all quality services, and ensure all aspects of team activities comply with cGMP, legal, regulatory requirements and Sandoz corporate Quality Manual and Policies.
  • Be the registered Pharmacist for Sandoz Viet Nam warehouse to be responsible for entire professional activities of SDZ's warehouse including compliance with management regulations relating to product quality; be responsible or authorizing to an equivalent qualified person for approval of product receipt and release.

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:

What you'll bring to the role:

  • Bachelor's Degree or equivalent 4-Year University degree in a Scientific or Technology field (e.g. Chemistry, Pharmacy or other Life Science). Advanced degree preferred.
  • Fluency in English and local language (oral and written), additional language(s) a plus.
  • More than 5 years of experience in Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development.
  • Expert understanding of GxP regulations from major Health Authorities; Prior experience in the development and implementation of Quality Management Systems incl. Compliance & Auditing and dealing with Health Authorities.
  • Experience in Regulatory submissions and registration, Product Lifecycle and product portfolio management.
  • Demonstrated ability to build trusting relationships with senior management and other business stakeholders.
  • Ability to initiate and drive organizational change in complex matrix environment; lead others through change, effectively manage resistance, and ensure organizational engagement, influence and drive/facilitate change across the organization.
Why Sandoz?

  • 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 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 groundbreaking 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


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