QC Associate

QC Associate - System Support (Equipment Qualification/ Validation/Pharma)

Location : Gul Circle

Salary Up to $5,000 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.

Requirements

• 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.
• Excellent 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

Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579

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