QC Associate

6 days ago

Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full time

Overview
QC Associate - System Support (Equipment Qualification/ Validation/Pharma)
Location : Gul Circle
Salary Up to $4,500 depending on experience
Completion Bonus 1 Month
Our client delivers vital healthcare solutions worldwide, powered by the precision and dedication of its Manufacturing & Supply teams. With your talent, they can expand their impact—protecting more people and offering hope to patients and their families.
Responsibilities
Updating the site validation master plan and procedures related to ALCM and CPV of GXP lab equipment.
Support periodic analytical method control trend review/ investigation and data evaluation on method performance, recommend method improvements where appropriate.
Support the life cycle management of the QC lab equipment i.e qualification of QC equipment and periodic review are maintained for their intended use.
Decommissioning of QC equipment and maintaining up to date the lab equipment inventory.
Participate in proper documentation issuance and review of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports.
Support laboratory qualification investigation and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs.
Providing support during regulatory inspections and audits.
Prepare metrics and monitoring data for the qualification and validation activities, to identify trends and issues, during life cycle management of QC laboratory equipment.
Support initiatives for continuous improvement in QC support processes related to lab equipment management in coordination with QC excellence team.
Support invalid assay trending program in the QC laboratory.
Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements.
Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records related to these tasks.
Qualifications
Minimum of two (2) years of experience
in quality control within the pharmaceutical industry , including
good knowledge of Good Manufacturing Practices (GMP)
and regulatory requirements, with hands-on exposure and theoretical requirement of
QC laboratory instruments and ALCM management .
Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology
Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.
Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.
Good understanding of
good laboratory practices, good documentation practice and data integrity requirements.
Experienced in analytical method continuous monitoring requirements.
Strong interpersonal relationships to establish the partnerships necessary for the development of the Quality culture.
Lim Pey Chyi -

Recruitment Consultant (R )
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
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