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QC Scientist [Pharmaceutical]

Randstad Malaysia

Johor Bahru

On-site

MYR 100,000 - 150,000

Full time

5 days ago
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Job summary

A leading pharmaceutical manufacturing company seeks a QC Scientist in Johor. The role involves performing rigorous physical and chemical analyses, maintaining regulatory compliance, and overseeing laboratory operations. Candidates should hold a relevant Bachelor’s degree and possess strong analytical skills and knowledge of pharmaceutical standards.

Benefits

Attractive remuneration and benefits package

Qualifications

  • Degree in Chemistry, Science, Biotechnology, or related field.
  • Experience in pharmaceutical industry is a plus.
  • Proficient in Microsoft Office and Oracle systems.

Responsibilities

  • Perform physical and chemical analyses in compliance with SOPs.
  • Lead Method Transfer and Method Validation activities.
  • Inspect raw materials and issue Certificates of Analysis (COAs).

Skills

Analytical skills
Troubleshooting laboratory equipment
Understanding of USP/NF standards

Education

Bachelor Degree in Chemistry, Science, Biotechnology, or related field

Tools

Analytical balances
pH meters
HPLC/UPLC systems
Gas chromatographs

Job description

We are currently looking for a QC Scientist for a leading player in the Pharmaceutical Manufacturing Industry with a legacy of more than 20 years in the world. This position requires your urgent attention.

  • Reporting to: Quality Manager
  • Based in Johor
  • Attractive remuneration and benefits package

the job

  • Perform physical and chemical analyses in compliance with SOPs, cGMP, GLP, and applicable regulatory standards (FDA, DEA, OSHA).
  • Utilize advanced understanding of regulatory guidelines and pharmacopeial standards in laboratory practices.
  • Carry out and document raw material, in-process, finished product, validation, and stability testing in accordance with approved methods.
  • Lead and ensure successful completion of Method Transfer and Method Validation activities within the QC laboratory.
  • Conduct comprehensive testing including assays, impurity profiling, content uniformity, identification, LOD, moisture, particle size, and bulk/tapped density.
  • Inspect raw materials and issue Certificates of Analysis (COAs) within defined timelines, maintaining accuracy in Oracle-based systems.
  • Ensure lab equipment is properly maintained and functional; oversee microbial testing and environmental monitoring in GMP areas.
  • Train QC staff, troubleshoot testing issues, review documentation, and ensure adherence to SOPs and industry regulations.
  • Author and review COAs and stability reports; ensure compliance with ISO 9001, safety protocols, and internal quality systems.
  • Participate in special projects, lean initiatives, and process enhancements across QC, logistics, and supply chain functions, while fulfilling other assigned duties.

the experience

  • Holds a degree in Chemistry, Science, Biotechnology, Biochemistry, or a related field; experience in the pharmaceutical industry is an added advantage.
  • Skilled in performing chemical analyses and troubleshooting laboratory equipment, with hands-on experience using instruments (e.g. analytical balances, pH meters, Karl Fischer titrators, TOC analyzers, FT-IR spectrophotometers, HPLC/UPLC systems, and gas chromatographs).
  • Possesses advanced knowledge of USP/NF standards relevant to solid dosage pharmaceutical manufacturing.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint), Outlook, and Oracle systems, with strong English reading and writing abilities.
  • Demonstrates a solid understanding of analytical and pharmaceutical sciences, including pharmacopeial standards, chemical stoichiometry, and diverse analytical methodologies.

skills

no additional skills required


qualifications

no additional qualifications required


education

Bachelor Degree

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