Contract, Office hours, 5 days
Position Overview
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.
Requirements
- Good knowledge of cGMP pharmaceutical manufacturing and inspection requirements of pharmaceutical products.
- 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.
If you are interested in the position, do kindly drop your most updated resume to [email protected] (Attn: Senior QC)
Thank You.
Lynn Ho
R23114223
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
