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.
Responsibilities:
ยท Involve in hands-on execution of the plant operations and assist Manufacturing
ยท Associates in troubleshooting
ยท Monitor and analyse processing parameters for atypical trends and improvement opportunities
ยท Perform solution and equipment preparation
ยท Stage components for autoclaving and washing
ยท Support in-process testing of production samples, prior experience with analytical instrument will be a plus point
ยท Actively support continuous improvement initiatives
ยท Support Safety audits
ยท Adhere to any applicable EHS and regulatory requirements
ยท Ability to follow written procedures, recognize and report malfunctions
ยท Evaluate documentation/data according to company and regulatory guidelines
ยท Engage & interact with inspectors (internal and external)
ยท Interpretation and application Good Manufacturing Practice (GMP) knowledge is required
ยท Basic statistical mathematical skills
ยท Ability to organize work and handle multiple priorities and meet deadlines
ยท Need to understand, apply and evaluate basic chemistry, biology and physical principles
ยท Understanding of analytical methods
Basic Qualification:
ยท Diploma in Science or Engineering
Preferred Qualification:
ยท NTC/ITC/Diploma in Chemical, Pharmaceutical, Life Sciences or Bio-processing related disciplines
ยท Fresh graduates are strongly encouraged to apply.
ยท Proficiency in reading and writing English
ยท Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation, prior experience and demonstration of cGMP knowledge is a plus
ยท Knowledge of plant and unit operations (autoclave, parts washers, process equipment), good problem-solving skills
ยท Excellent self-motivated team player with hands-on attitude and good communication skills
ยท Experience with Emerson DeltaV, LIMS, TrackWise
ยท Should understand, apply and evaluate basic chemistry, biology and physical principles
ยท Required to work any shift in support of operations that may include 24/7
ยท Mechanical ability/expertise