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QC Specialist / Chemist (Pharmaceutical MNC, QC Equipment Qualification Exp, Protocol Writing in GMP Env) #HDC
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EA License No.: 99C4599
a year ago
Posted date
a year ago
Mid-levelMinimum level
Mid-level
ChemicalJob category
Chemical
R1551708
EA Personal Registration No.
R1551708
  • Perform analyses and tests of drug products, raw materials, in-process materials, release test samples or stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications
  • Perform a variety of qualitative tests or qualitative assays on samples using techniques that vary from standard analytical equipment to modern and automated instrumentation.
  • Utilize electronic laboratory information systems for acquisition and processing of analytical data
  • Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation
  • Ability to write technical documents (i.e. protocols, reports, change controls, SOPs)
  • Advanced knowledge of analytical chemistry, chromatography (HPLC/UHPLC) and drug dissolution testing
  • Serve as a mentor for more junior analysts within the team providing guidance and direction as needed
  • Broader understanding of other aspects of the business and apply quality principles when reviewing documentation and making decisions/ suggestions
  • Stays current on new requirements & making associated recommendations that affect area of expertise. Qualifications Education and Experience Required:
  • Thorough knowledge and understanding of USP, cGMP, ICH and HSA guidelines
  • Use of risk assessment tools within own area using knowledge, managing risk and assessing impact to make decisions
  • Promote Quality and GMP by analyzing the implications of deviations, and implement solutions under guidance. Continuous Improvement:
  • Provide feedback on systems and processes to promote continuous improvement and champion selected changes
  • Grow in the job, accountable for establishing and accomplishing annual personal development goals Communication:
  • Participate in daily direction setting huddles to provide feedback and ensure alignment on daily/weekly/monthly objectives
  • Actively participate in regular one-on-one meetings with direct supervisor Problem Solving:
  • Troubleshoot problems encountered with methods and instruments - routinely solve, choosing among clearly defined alternatives
  • Ability to independently solve more complex problems – takes new perspective using existing solutions
  • Applies root cause problem solving principles for identification and implementation of effective corrective and preventive actions

 

Requirements:

  • Min Degree in Science or equivalent with at least 2  years of relevant experience in the pharmaceutical / chemical industry.
  • Experience in operating laboratory equipment such as HPLC, GC , KF Titrators. 
  • Working knowledge of cGMP and regulatory requirements related to Quality is an advantage
  • 5 days office hours

If you are interested in the position, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg  (Attn: Senior QC Analyst)

 

Thank You.

 

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

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JOB SUMMARY
QC Specialist / Chemist (Pharmaceutical MNC, QC Equipment Qualification Exp, Protocol Writing in GMP Env) #HDC
Singapore
a year ago
Mid-level
Full-time