Senior QC Chemist (Biochemistry, Pharma MNC) - HTJ

Recruit Express Pte Ltd; Singapore; Sur place; SGD 39 000 - 56 000; Plein temps

Résumé du poste

Recruit Express Pte Ltd is seeking a Biochemistry Lab Analyst to join our quality testing team in Singapore. You will perform biochemistry analyses on raw materials, in-process and finished products to ensure GMP compliance and timely batch release.

Requirements: a minimum bachelor degree in Biochemistry with 2–3 years of lab analyst experience in bio-chemistry functions; ability to work 12-hour rotating day/night shifts; good record-keeping and familiarity with USP/JP/EP guidelines.

Qualifications

• Bachelor degree in Biochemistry (or higher) required.
• 2–3 years of prior lab analyst experience in biochemistry-related functions.
• Able to work 12-hour rotating day and night shifts.

Responsabilités

• Perform biochemistry, analytical and raw material testing for lot release per GMP.
• Maintain laboratory records to appropriate requirements and keep equipment clean and calibrated.
• Support method transfer, equipment qualification, calibration and maintenance.

Connaissances

Biochemistry lab experience

Quality control

Documentation

Formation

Bachelor degree in Biochemistry

Description du poste

Primary Goals/Objectives:

To provide an effective testing and analytical service to the plant ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met.

Ensure that all raw material, in-process and finished product testing and method transfer testing is carried out per schedule and per GMP. Ensure that records are maintained to appropriate requirements.

Major Responsibilities:

• Perform biochemistry, analytical and raw material of in-process and marketed products for lot release in accordance with quality standards and procedures.
• Responsible for housekeeping duties in the lab. Perform Quality Tag Out for laboratory equipment such as freezer, water bath and etc.
• Support laboratory operations including but not limited to method transfer, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables, waste management, reagent and media preparation, critical reagent management and document management.
• Review lot release data, identify testing discrepancies and participate in laboratory investigations.
• Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness.
• To assist in writing SOP documents, Change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design.
• To carry out completion and review of GMP Documentation of data sheets or LIMS software.
• To carry out QC sample receipt, assay and release procedures.
• Support Audit preparation and any audit related activity
• Reading and understanding the test procedure and the requirements per USP, JP and EP.

Requirements:

• min. Bachelor Degree in Biochemistry and above
• Possess 2-3 years of prior lab analyst experience in bio-chemistry related functions
• Able to do 12 hour rotating day and night shift