QC Specialist

1 week ago


Singapore RANDSTAD PTE. LIMITED Full time
Roles & Responsibilities

QC Specialist (Analytical)

(12-month contract)

About the Company:

Our client is a Swiss pharmaceutical based corporation that provides solutions to address the evolving needs of patients worldwide. Their main discoveries are development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products.

Primary Responsibilities:

In this role, you will be responsible for establishing and ensuring testing of drug substance release and stability testing including testing of intermediates in process control samples and lab operations are in accordance with written testing SOP’s and local/international regulations.

The responsibilities includes:

  • Establish and ensure Quality Control (QC) Drug Substance (DS) lab in full cGMP-compliance and daily operational activities in full cGMP-compliance.
  • Review and validate product testing results and analysis under cGMP and meet required timelines.
  • Provides technical support to run and validate necessary test methods on lab equipment and resolve day to day lab operations including troubleshooting of lab equipment and processes.
  • Coordinate and implement short to mid-term projects by collaborating with other functions to achieve team goals.
  • Reviewing and Approving method transfer/validation protocols and reports.
  • Carry out investigations and establish root cause and prepare report findings according to global and local standards and requirements.
  • Act as SME (Subject Matter Experts) to train and guide site personnel to perform new methods and instrumentation, other lab related areas and audit preparation.
  • Monitoring and optimization of work flows and methods/procedures, drug substance control, method controls and reference’s and perform trending of on-going in process control data to pursue an on-going quality assurance program.
  • Reviews/Approve all lab related QA/QC documents to ensure completeness, accuracy, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs.
  • Recommend and execute improvements to current processes or systems including creating new test procedures to deliver set KPIs.
  • Prepare and participate in health authorities inspections and internal audits in respective area.
  • Support and supervise team on day to day lab operations as and when required.

Requirements:

  • Diploma or Bachelor’s degree in pharmaceutical or any relevant field
  • At least 3 years of experience in analytical testing (i.e. HPLC-EMPOWER, CE, UV spectrophotometer )
  • At least 3 years of applied professional work experience in laboratory quality control
  • Familiar with GMP

Reg No: R22104540

EA License no: 94C3609


Tell employers what skills you have

Troubleshooting
Quality Control
Quality Assurance
GMP
Marketing
Audits
Instrumentation
UV
Process Control
Laboratory
Audit
Technical Support
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