QC Associate - Pharma Equipment Validation & System Support

Manpower Staffing Services (Singapore) Pte Ltd; Singapore; Presencial; SGD 66.000 - 79.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Completion bonus 1 month

Descripción de la vacante

Manpower Staffing Services (Singapore) Pte Ltd is seeking a QC Associate - System Support (Equipment Qualification/ Validation/ Pharma) in Singapore. The role focuses on maintaining GMP-compliant QC lab equipment and supporting qualification activities within the QC lab.

The ideal candidate has 5+ years in pharmaceutical QC, strong GMP knowledge, and experience with equipment qualification and data integrity.

Formación

• 5+ years of experience in quality control within the pharmaceutical industry.
• Good knowledge of GMP and regulatory requirements.
• Hands-on exposure to QC laboratory instruments and ALCM management.

Responsabilidades

• Update the site validation master plan and procedures related to ALCM and CPV of GXP lab equipment.
• Support periodic analytical method control trend review and data evaluation on method performance.
• Support life cycle management of QC lab equipment and qualification/maintenance documentation.
• Decommission QC equipment and maintain up-to-date lab equipment inventory.
• Participate in documentation reviews for qualifications, risk assessments, protocols, reports and deviations.

Conocimientos

Quality control experience

GMP knowledge

Regulatory compliance

QC laboratory instruments

ALCM management

Educación

Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology

Descripción del empleo

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

Location : Gul Circle

Salary Up to $6,500 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.

Requirements

• Minimum of 5 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.

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