Compliance & Qualification Engineer

265101BR
Compliance & Qualification Engineer

Job Description

Job Purpose

Execute facility and equipment qualification in compliance with internal quality systems & standards (e.g. asset change controls, re-qualification, QMs/QDs, GPE guidelines, SOPs) and fully meet expectations of internal (GCA) and external authorities (FDA, PMDA, HSA, EMA etc.).

Key Responsibilities

• Execute facility and equipment qualification in compliance with internal quality systems, standards and SOPs (e.g. asset change controls, qualification, QMs/QDs, GPE guidelines, SOPs) and fully meet expectations of internal (GCA) and external authorities (FDA, PMDA, HSA, EMA, others).
• Execute routine periodic re-evaluation of quality relevant systems/equipment and re-qualification of classified room, Cold Room/Freezer, unidirectional flow work zone, biosafety cabinet, laminar air flow work station or chemical fume hood etc.
• Write and execute of the qualification protocols and reports related to qualification activities (eg., DQ, IQ, OQ and PQ).
• Support the compliance and timely closure of quality related activities and events as well as monitoring the progress of all due activities.
• Support Asset Change Control, Qualification, Documentation, Logbooks and WOs; ensure actions and CAPAs are timely executed.
• Support investigations and root cause analysis for all quality issues and events (e.g. deviations; trends, complaints).
• Work and interact closely with QA Validation to ensure compliance with company policies and procedures.
• Acquire and maintain knowledge in his/her area of specialize.
• Participate in meetings concerning qualification and documentation.
• Recommend and execute improvements in documentation and archiving in order to achieve compliance, reducing waste and improving efficiencies.

Minimum requirements

• Degree in Engineering or Facility Management – preferably in Chemical, Mechanical, Industrial, Quality or Pharmaceutical Engineering
• Minimum 2 years of Biotech or Pharmaceutical cGMP experience required
• Extended documentation experience.
• Excellent technical writing skills.
• Excellent analytical thinking skills.
Novartis Technical Operations
NTO BTDM
Singapore
Singapore
NOV SINGAPORE PHARMA MANUFG
Technical Operations
Full Time
Regular