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Open nowPosted 2 days ago

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

RECRUIT EXPRESS PTE LTD

Pay
SGD 2,500 – SGD 3,000 a month
Where
Central, Singapore
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Your applicationOpen nowQA/QC Assistant (Up to $3000, Paya Lebar, Pharmaceutical) #HJYRECRUIT EXPRESS PTE LTD · Central, Singapore

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This job: posted 2 days ago

The posting

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]

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