QC Systems Analyst (Quality Control, Pharmaceutical MNC, GMP, Medical)

Recruit Express Pte Ltd; Singapore; Vor Ort; SGD 60.000 - 90.000; Vollzeit

Zusammenfassung

Recruit Express Pte Ltd is seeking a QC Systems Analyst to oversee quality control functions for investigational products in clinical studies, including inspection, sampling, and disposition of materials. You will investigate laboratory incidents, review investigations, and ensure compliance with ICH, cGMPs, and regional requirements.

The role requires a degree in Science or equivalent with 2+ years in pharma/chemical industries, familiarity with HPLC/GC/KF titrators, and strong data

Qualifikationen

• Good knowledge of cGMP pharmaceutical manufacturing and inspection requirements.
• 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

Aufgaben

• 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.

Kenntnisse

cGMP knowledge

Data interpretation

Detail oriented

Time management

Interpersonal skills

Team player

Ausbildung

Bachelor's degree in Science or equivalent

Tools

HPLC

GC

KF titrators

Jobbeschreibung

QC Systems Analyst (Quality Control, Pharmaceutical MNC, GMP, Medical)

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.
• 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.

Requirements

• 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

Thank You.