Officer, Quality Control Testing

RXinsider LTD.; Hinoba-an; On-site; PHP 350,000 - 550,000; Full time

Job summary

RXinsider LTD. is seeking an Officer – Quality Control in the Philippines to execute routine QC laboratory activities, support stability studies, and ensure data integrity under cGMP/GLP guidelines. The role covers raw material, in-process, and finished product testing, documentation, and CAPA implementation.

The candidate should have a relevant advanced degree and 1–5 years of hands-on QC experience in an API manufacturing environment, with familiarity in LIMS and SOP adherence.

Qualifications

• Advanced degree in chemistry or a related field preferred.
• 1-5 years hands-on QC experience in an API manufacturing facility.

Responsibilities

• Execute routine preventive maintenance, calibration, and verification activities of QC instruments as per approved SOPs.
• Perform analysis and support timely release of raw materials, intermediates, and packing materials as per approved specifications.
• Ensure day-to-day compliance with GLP, safety practices, and laboratory housekeeping requirements.
• Execute stability sample charging, withdrawal, testing, and documentation as per approved stability protocols.
• Support investigation of deviations, OOS, OOAL, and laboratory incidents; assist in implementation of CAPA.
• Prepare, revise, and follow QC-related SOPs, test methods, and specifications; ensure compliance in routine work.
• Perform audit trail checks and ensure adherence to data integrity requirements for computerized systems.
• Enter, verify, and maintain accurate analytical data and sample status in LIMS.
• Participate in training programs and support knowledge sharing within the QC team.
• Maintain analytical columns, reference standards, and laboratory consumables as per SOPs.

Education

M.Sc / M.Pharm / B.Pharm – Chemistry or related discipline preferred

Tools

LIMS

Job description

Job Description

Officer – Quality Control is responsible for executing and supporting routine QC laboratory activities, including analysis, documentation, and compliance with cGMP and GLP requirements. The role involves handling raw material, in-process, and finished product testing, supporting stability studies, maintaining instrument compliance, and assisting in deviation/OOS investigations. The position also supports data integrity, SOP adherence, and continuous improvement initiatives within the QC function.

Essential Functions – Officer, Quality Control

• Execute routine preventive maintenance, calibration, and verification activities of QC instruments as per approved SOPs.
• Perform analysis and support timely release of raw materials, intermediates, and packing materials as per approved specifications.
• Ensure day-to-day compliance with GLP, safety practices, and laboratory housekeeping requirements.
• Execute stability sample charging, withdrawal, testing, and documentation as per approved stability protocols.
• Support investigation of deviations, OOS, OOAL, and laboratory incidents; assist in implementation of CAPA.
• Prepare, revise, and follow QC-related SOPs, test methods, and specifications; ensure compliance in routine work.
• Perform audit trail checks and ensure adherence to data integrity requirements for computerized systems.
• Enter, verify, and maintain accurate analytical data and sample status in LIMS.
• Participate in training programs and support knowledge sharing within the QC team.
• Maintain analytical columns, reference standards, and laboratory consumables as per SOPs.

Qualifications

QUALIFICATIONS

Education

• M.Sc / M.Pharm / B.Pharm – Chemistry or related discipline preferred.

Experience

• 1-5 years of hands-on experience in QC operations within an API manufacturing facility.