Azura Shah
@azurashah
I strengthen pharmaceutical quality systems, GMP compliance, validation, and inspection readiness across manufacturing operations.
MalaysiaWhat I'm looking for
I've supported pharmaceutical quality systems and manufacturing compliance at 23 Century International Life Science Centre, Novugen Pharma, and Duopharma Manufacturing. My work spans GMP, PIC/S, cGTP, ISO, QMS documentation, batch review, product release, and audit readiness.
At Novugen Pharma, I managed deviations, CAPA, change controls, OOS/OOT investigations, APQRs, quality metrics, complaints, recalls, and regulatory inspection support. I participated in NPRA and USFDA audits, including an NPRA audit with zero observations and a subsequent USFDA audit with zero Form 483 observations.
I've also prepared high-volume BMR and BPR documentation, supported qualification and validation activities, managed supplier records, and applied GDP and ALCOA+ data-integrity principles. My laboratory background includes IPQC and raw-material, in-process, and finished-product testing that supports reliable batch release.
Experience
Work history, roles, and key accomplishments
Senior Executive, Quality Assurance
23 Century International Life Science Centre
Apr 2026 - Present (5 months)
Maintains compliance with GMP, PIC/S, cGTP, ISO and QMS requirements, manages deviations, CAPA, change controls, and supports audits and inspections.
Executive, Quality Assurance
Novugen Pharma Sdn Bhd
May 2025 - Mar 2026 (10 months)
Managed QMS activities, prepared and reviewed controlled documentation, handled deviations, CAPA, change control, OOS/OOT investigations, and supported NPRA and USFDA inspections.
Executive, Production – Compliance
Novugen Pharma Sdn Bhd
Jan 2023 - Apr 2025 (2 years 3 months)
Monitored manufacturing operations for cGMP compliance, prepared and reviewed BMR/BPR, led OOS/OOT investigations and CAPA tracking, and supported product release and regulatory inspections.
Associate Executive, Production – Compliance
Novugen Pharma Sdn Bhd
Sep 2021 - Dec 2022 (1 year 3 months)
Ensured manufacturing activities met quality specifications and GMP requirements, prepared compliance documentation for regulatory submissions, and supported continuous improvement initiatives.
Protégé Trainee – GMP Laboratory / Production Support
Duopharma Manufacturing (Bangi) Sdn Bhd
Nov 2020 - Aug 2021 (9 months)
Performed raw-material, in-process and finished-product testing in a GMP laboratory, conducted IPQC testing, and supported batch-release activities.
Education
Degrees, certifications, and relevant coursework
University Tun Abdul Razak (UNIRAZAK)
Master of Business Administration, Finance
2025 -
Grade: CGPA 3.76
Pursuing a Master of Business Administration in Finance with a CGPA of 3.76.
KPJ Healthcare University
Bachelor of Pharmaceutical Science with Health Sciences (Hons), Pharmaceutical Science with Health Sciences
2016 - 2020
Grade: CGPA 3.31, Second Class Upper
Completed a Bachelor of Pharmaceutical Science with Health Sciences (Hons) with a CGPA of 3.31, achieving Second Class Upper.
Manipal International University
Foundation in Science, Science
2015 - 2016
Grade: CGPA 3.31
Completed a Foundation in Science with a CGPA of 3.31.
Tech stack
Software and tools used professionally
Availability
Location
MalaysiaAuthorized to work in
Salary expectations
Skills
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