QC Systems Validation Specialist – Pharma/ Contract

Roles & Responsibilities

QC Systems Validation Specialist – Pharma/ Contract

6 Months Contract

Location: Tuas

Up to $8,000 depending on experience

Industry: Pharmaceutical

Our client aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges.

Job Summary:

• Expertise in equipment validation, with a focus on qualifying critical QC instruments such as environmental monitoring air samplers and particle counters

Responsibilities:

• Support the implementation and maintenance of QC GxP Systems in compliance with company’s Standards and Regulatory guidance, which includes:
• Write and/ or execute IQ and OQ test protocols for QC Laboratory Computerized systems/ electronic equipment, including writing of exception reports.
• Author Qualification Summary Report for QC Equipment.
• Author QC Systems associated procedures such as administrative SOPs and configuration specifications, as required.
• Partner with QC to conduct data integrity risk assessment.

Requirements:

• Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with at least 5-7 years of experience in QC raw material testing.
• Experience in method validation/ verification in the pharmaceutical or biotechnology industry
• Good understanding of good laboratory practices, good documentation practice and data integrity requirements.
• Experienced in start-ups will be ideal

Lim Pey Chyi - Apple.lim@manpower.com.sg

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423

Tell employers what skills you have

Good Documentation Practices
Formulation of SOPs
Pharmaceutical chemistry
regulatory standards
Start-ups
Biotechnology Industry
Validate Test Methods
GCP compliance
Data Quality Assurance
Laboratory Techniques
Electronic Devices
Writing
Qc Equipment
Fault Reporting
Test Protocols
Analytical Method Validation