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:

• Executes batch records, ensuring right-first time and accurate documentation
• Involve in hands-on execution of the plant operations and performing trouble-shooting
• Monitor and analyze processing parameters for atypical trends and improvement opportunities
• Perform solution and equipment preparation
• Actively support continuous improvement initiatives
• Adhere to any applicable EHS and regulatory requirements
• Ability to follow written procedures, recognize and report malfunctions
• Evaluate documentation/data according to company and regulatory guidelines
• Interpretation and application Good Manufacturing Practice (GMP) knowledge is required
• Ability to organize work and handle multiple priorities and meet deadlines
• Need to understand, apply and evaluate basic chemistry, biology and physical principles
• Performs environmental monitoring during production
• Performs production support activities, e.g. equipment cleaning, housekeeping and escalates non-routine situations (e.g. deviations, equipment alarms) per site procedure

Qualifications:

• 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 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