• Supports Site IT Lead or program/project leads to ensure effective project management, system qualification & operation support.
• End to End qualification lead/support for Automation/Laboratory systems with adherence to GMP/SLC principles.
• Lead author all System LifeCycle documents assossiated with the system. * Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs
• Work with Systems owner(s) to ensure the initiation and implementation of global change control activities are in accordance with site procedures.
• Practices a culture of continuous learning, develops business and technical skills, identifies opportunities to skill-up of individual and Team.

Requirements

• Degree in IT, Science or Engineering
• Excellent written and verbal communication skills
• Strong organizational and project management skills
• 2-4 years validation experience in a cGMP Pharmaceutical/ Biopharmaceutical manufacturing environment

Other information
12months Contract with attractive remuneration package!
Location: Tuas

Interested applicants, please email resume to; yenleng.yap@manpower.com.sg (R1110894)

Yen Leng Yap EA License No. 02C3423 Personnel Registration No. R1110894

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