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 instrument will be a plus point
• 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)
• Interpretation and application Good Manufacturing Practice (GMP) knowledge is required
• Basic statistical mathematical skills
• Ability to organize work and 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
• Possess minimum 0 - 2 years of relevant experience in the biotechnology, pharmaceutical or petrochemical industry. Fresh graduates will be considered.
• 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
• Mechanical ability/expertis
