Job Description

No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.Scope & Responsibilities

• Learn & perform well-defined procedures
• Executes batch records, ensuring right-first time and accurate documentation
• Use Standard Operating Procedures (SOPs), logbooks & Batch Records (BRs) or other GMP documents effectively & competently
• Understand in general the BR and logbook review process/ workflow
• Involve in hands-on execution of the plant operations and performing trouble-shooting
• Monitor and analyze processing parameters for atypical trends and improvement opportunities
• Pursue ongoing training to increase knowledge & understanding
• Attain good understanding of cGMP requirements & compliance within a GMP manufacturing setting
• Perform assigned tasks (by Section Lead/ Manager) both with and without supervision
• Perform equipment monitoring & basic 6S housekeeping
• Perform basic laboratory tasks (e.g. sampling, pH/ conductivity/ osmolality measurements etc.)
• Perform routine sanitization tasks to maintain facility standards
• Demonstrate aseptic technique in the handling of product/ materials
• Able to multi-task on equipment preparations & operations to ensure adherence to schedule
• Display basic process & equipment troubleshooting ability under routine Scenarios
• Exhibit full understanding of critical process/ operational parameters and target/ acceptable ranges
• Understand process flow from scheduling & resource loading perspective
• Exhibit basic understanding of the entire process e.g. interactions between different process parameters
• Has operating knowledge of DeltaV Control System
• Operate DeltaV Control System independently for daily routines, historian data retrieval/ trending/ printing
• Understand the deviation system/ workflow overview
• Able to perform physical activities in a clean room environment and be on the feet most of the time. Able to perform manual work (

60% of activities) in a buddy system that includes standing, carrying items that weigh up to 12 kg, or moving equipment * Able to perform rotating 12-hour shift patternQualifications

• Diploma/Degree in Science disciplines or working experience in biopharmaceutical industry or cleanroom environment
• Strong team-oriented work ethic
• Attention to detail
• Planning, Organizing, & Controlling
• Effective Communication - clear and concise (both written and oral)
• Willing to perform rotating 12-hour shift pattern
• Able to work independently, manage stress and adhere to production schedule will support to manage Amgen\'s enquiries during Amgen\'s normal working hours and

after hours (if required).
\xe2\x9a\xab Provider will place experienced and qualified personnel with the appropriate level of training
and experience at Amgen site for durations based on Amgen needs. The change of resources
shall be approved by Amgen.
\xe2\x9a\xab Periodic review on service level performance based on agreed KPI if required. Frequency to
be aligned between Provider and Amgen.
\xe2\x9a\xab Personnel is encouraged support and make recommendation to Amgen for continuous
improvement including but not limited to cost reduction, technical support etc.

No deviation