QA/QC Assistant (Up to $3000, Paya Lebar, Pharmaceutical) #HJY

Recruit Express Pte Ltd; Singapore; On-site; SGD 28,000 - 33,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a QA/QC Assistant in Singapore to support GMP compliance, QC activities and QMS documentation in a pharmaceutical setting. The role involves maintaining SOPs, QA records and assisting in audits and regulatory communication.

The position requires a Diploma in Science (Nitec/Diploma) with relevant experience considered an advantage; salary ranges from SGD 2,500 to SGD 3,000 per month, working in Paya Lebar on a permanent basis.

Qualifications

• Min Nitec/Diploma in Science.
• Relevant experience would be an added advantage.

Responsibilities

• Prepare, review, revise and implement SOPs and QMS documents in GMP framework.
• Ensure compliance with GMP requirements and company procedures.
• Perform QC activities including sampling, testing and review of reports for product disposition.
• Support batch/product release activities according to specs and procedures.
• Investigate OOS, deviations and non-conformances; implement CAPA.
• Coordinate calibration activities and validation studies per master plans.
• Manage documentation such as COAs, product specs and QA records.
• Assist in internal audits and regulatory submissions as needed.

Skills

Quality Assurance

GMP

QA/QC

Laboratory Testing

Document Control

Education

Nitec/Diploma in Science

Job description

Recruit Express will never request for your Singpass details in our recruitment process. Please contact us at 6732 6006 or email to [e-mail] if you are unsure if it is a scam.

QA/QC Assistant (Up to $3000, Paya Lebar, Pharmaceutical) #HJY

Location: Paya Lebar
Duration: Permanent
Salary: $2500 - $3000
Working days and hours: 5 days, Office Hours

Job Description:

• Prepare, review, revise and implement Standard Operating Procedures (SOPs) and other Quality Management System (QMS) documents in accordance with applicable GMP requirements.
• Ensure compliance with GMP requirements and established company procedures.
• Perform Quality Control (QC) activities, including sampling, arranging laboratory testing according to approved specifications, reviewing analytical/test reports and assessing test results for product disposition.
• Support and/or perform batch/product release activities in accordance with approved specifications and procedures.
• Manage and investigate Out-of-Specification (OOS), deviations, non-conformances and other quality-related issues, including root cause investigation and Implementation of appropriate CAPA.
• Perform sampling and testing activities and coordinate with external testing laboratories where applicable.
• Develop, review and maintain product specifications, test methods, analytical reports, Certificates of Analysis (COA) and related quality documents.
• Plan and coordinate calibration activities in accordance with the Calibration Master Plan.
• Plan, coordinate and perform process and equipment validation activities, including preparation and review of validation protocols and reports.
• Manage stability studies, retention samples, change controls, document control and product technical files.
• Conduct Product Quality Reviews (PQR) and quality risk assessments/management.
• Manage the retention sample room and ensure proper storage, identification and traceability of retention samples.
• Conduct Environmental Monitoring of production areas and review monitoring results to ensure compliance with established requirements.
• Support new product formulation, product development and Research & Development (R&D) activities from a quality and regulatory perspective.
• Conduct GMP training and participate in internal audits, including follow-up and closure of audit findings.
• Conduct and/or participate in supplier, contract manufacturer and external audits.
• Manage customer/product complaints, conduct investigations and propose appropriate CAPA and follow-up actions.
• Support regulatory submissions, product registration and maintenance activities, including liaison with HSA and other relevant regulatory authorities regarding regulatory and quality matters.
• Liaise with internal and external stakeholders to support and streamline the regulatory requirements and export of company products.
• Maintain and continuously improve the company's QMS and ensure effective implementation of quality systems.
• Perform any other duties or activities reasonably assigned by management.

Job Requirements:

• Min Nitec/Diploma in Science
• Relevant experience would be an added advantage

(CEI.No: R2197564 | Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)