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