QC Specialist / Chemist (Pharmaceutical MNC, QC Equipment Qualification Exp, Protocol Writing in GMP Env) #HDC
Job post no longer accepts applications
- 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
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