Quality Assurance/Quality Control 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





If interested, please send updated resume via email [email protected]

Melissa Zhang Zhiqi (Mezzo)

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

[email protected]