Job Description

Responsibilities:

• Responsible for writing of qualification related documentation but not limited to Qualification Plan and IQ, OQ, PQ and ERES Test Scripts for QC laboratory equipment (lab bench and CSV system) and support EMPOWER 3 (CDS) deployment to QC lab.
• Responsible for execution of but not limited to IQ, OQ, PQ and ERES Test Scripts of QC laboratory equipment (lab bench and CSV system) and test script for EMPOWER 3 deployments.
• Manage and maintains the progress tracking matrix on document generation, qualification execution, document review and approval. Escalate the issue/delay to management team.
• Coordinate and manage deviation to be initiated, assessed and closed out in timely manner.
• Responsible for stakeholder management including coordination with QC lab team on equipment availability for qualification activity.
• Responsible for all other activities related to qualification activities but not limited to change control, tag out, PM/Calibration program, equipment configuration, SOP generation.
• Handover and coordination post LEQ execution to QC lab

About You:

• Bachelor in Engineering, Sciences, Business, Information Systems or equivalent. Min 5 years of experience in QC Lab Equipment Qualification in pharma or biotech facility.
• Knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
• Good interpersonal, communication and presentation skills.
• Must be a self-starter, fast learner, curious with strong analytical and organizational skills
• Self-motivated and willingness to learn
• Reliable and Responsible

Only shortlisted candidates will be notified.Contract length: 6-9 Months. Option to extend depending on performance and business needs.Location: TuasJob Types: Full-time, Contract
Contract length: 24 monthsSalary: $5,000.00 - $8,500.00 per monthCOVID-19 considerations:
All staff to observe MOH regulations and practicesEducation:

• Bachelor's or equivalent (Preferred)

Experience:

• QC Lab Equipment Qualification in Biopharmaceutical Industry: 5 years (Preferred)