Governance, Risk, Compliance Analyst - Kuala Lumpur, Malaysia - Novotech Asia

Novotech Asia
Novotech Asia
Verified Company
Kuala Lumpur, Malaysia

1 week ago

Siti Tan

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Siti Tan

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Description

Brief Position Description:

This role will be primarily responsible for the operation of Novotech's Information Security Management System.

The GRC Specialist acts as a primary point of contact for all ISMS and works with IT Compliance Director, Information Security Specialists, System Owners, Clinical Systems Team, QA team and Business Operation teams to maintain ISO 27001 compliance.


Minimum Qualifications & Experience:


  • Hands on working experience with security frameworks such as NIST-CSF, ISO 27001, ISM, etc.
  • Practical experience conducting risk and/or compliance activities in any ICT field.
  • Good working knowledge of relevant standards, security frameworks and regulations i.e. ISO, Essential 8, ACSC ISM, NIST, etc.
  • End to end understanding of regulatory guidelines including understanding of riskbased validation approach.
  • Audit experience on IT systems (GxP and Non GxP).
  • Good knowledge of FDA, EU and ROW regulations; knowledge of CSV Part 11, Annex 11, GAMP 5, NMPA and data integrity requirements.
  • Open to work on a fixedterm contract (12 months).

Responsibilities:


  • Assist in Quality Investigations, system audits, client audits and RCA/CAPA preparation.
  • Provide support to IT compliance manager for routine compliance checks and RFP responses.
Novotech is proud to offer a great workplace.

We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.


Our team members are passionate about what we do, but we understand work is only of the things that is important to them.

We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.


We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

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