Carries out quality control functions related to the manufacture, testing, and release of investigational products used in Phase I/II/III clinical studies. Responsible for the inspection, sampling and disposition of raw materials used in the manufacture of drug products. Conducts investigations and determines corrective actions of process and product deviations. Requires an ability to function effectively under timeline pressure and to provide solutions to a wide range of problems.
Main Areas of Responsibilities
- Investigates and resolves laboratory incidents.
- Performs the quality assurance review and approval of laboratory investigation reports including out-of-specification reports.
- Determines if corrective and preventative actions are adequate and evaluates the impact on materials.
- Performs quality assurance review and approval of analytical procedures for compliance with company policies, ICH and regional requirements.
- Assists in the preparation of quality agreements and performs periodic supplier evaluations to ensure compliance with regulatory requirements and company policies.
- Performs incoming quality control inspection of raw materials to ensure compliance to specifications and departmental procedures.
- Performs sampling of raw materials and coordinates with production planners and testing laboratories to ensure raw materials are tested and retested at the required inspection intervals.
- Tracks the status of raw materials from time of receipt to disposition.
- Manages the status and disposition of raw materials in SAP, including the retest/expiration dates of released raw materials.
- Performs sampling of the purified water system used in laboratory operations.
- Reviews water system trend reports and assists in identifying potential root causes of out-of-specification and out-of-trend results.
- Manages the clinical supply operations logbook system and performs the quality review of records to ensure compliance to company procedures and cGMPs.
- 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
- Good knowledge of cGMP pharmaceutical manufacturing and inspection requirements of pharmaceutical products.
- Interpreting multiple standards and applying them to department activities.
- Detail oriented with proven organizational skills.
- Handling a wide variety of tasks under time constraints.
- Interpreting and evaluating data and summarizing results.
- Good interpersonal skills with team player orientation,
- 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 email@example.com (Attn: QC Analyst)
Leon Leong De Cong
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599