Specialist -Quality Control

Pharmagend Global Medical Services Pte Ltd; Singapore; On-site; SGD 40,000 - 60,000; Full time

Job summary

A pharmaceutical company in Singapore is seeking a candidate for a laboratory position, focusing on quality control and compliance with regulatory guidelines. Responsibilities include executing analytical testing, preparing reagents, and maintaining laboratory documentation. The ideal candidate holds a degree in a science-related discipline and has a minimum of 2 years of relevant experience. This role provides a crucial impact on ensuring product quality and safety.

Qualifications

• Minimum 2 years of experience in a pharmaceutical environment.
• Thorough understanding of BP, USP, cGMP, and FDA guidelines.

Responsibilities

• Execute analytical testing and maintain data integrity.
• Prepare reagents and perform qualitative tests on samples.
• Utilize LIMS for processing analytical data.

Skills

Analytical chemistry

Chromatography (HPLC/GC)

Knowledge of cGMP and FDA guidelines

Electronic laboratory information systems (LIMS)

Education

Degree/Diploma in Science related discipline

Job description

Responsibilities

• Samples, and/or finished products from manufacturing to ensure quality standards and compliance with established specifications.
• Preparation of reagents/diluents/ dissolution media as per STP.
• Perform a various qualitative tests or qualitative assays on samples using modern and automated instrumentation.
• Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.
• Assist in maintenance and calibration of test instruments per specifications.
• Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.
• Knowledge of analytical chemistry, chromatography (HPLC/GC) and drug dissolution testing.
• Familiar with LIMS, and reporting of any observed results that do not meet the requirement [OOS/OOT/Deviation] for further investigation.
• Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.
• Ensure real time documentation.
• Maintain data integrity and appropriate traceability.
• Thorough knowledge and understanding of BP, USP, cGMP and FDA guidelines.
• Maintain a clean and safe work environment and follow safety procedures and policies.
• Create and maintain lab record documentation (notebooks and computer based) per GMPs.

Education & Experience

• Degree/Diploma in Science related discipline.
• Minimum 2 years of experience in a pharmaceutical environment.

Candidates are encouraged to apply this position via email to [e-mail] with the following information in the resume.

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background
• Only shortlisted applicants will be notify