About Nd Incorporated in 2007, we are a patient-centric solution provider for the pharmaceutical industry. We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe. We offer personalized focused solutions for the pharmaceutical industry in engineering consultancy and regulatory quality and compliance. With a sharp focus on delivering value-adding commissioning, qualification, and validation services, we are leading experts in developing the lean CQV methodology. We extend our offerings to GMP-certified software for environmental monitoring and contamination control, paperless validation, training, and professional recruitment services. We place keen attention on patient safety, process understanding, regulatory compliance and efficiency in the areas of safety, quality, delivery, and cost. At No deviation, we strive to deliver our best every day. We apply our core values of empathy, integrity, and transparency to every activity, including engagement with our candidates. We are an equal opportunity employer, value diversity, and promote inclusivity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. 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
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to interact with inspectors (internal and external)
Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
Requirements:
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.
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.
Experience with Emerson DeltaV, LIMS, TrackWise
Ability to understand, apply and evaluate basic chemistry, biology and physical principles
Ability and willingness to work any shift in support of operations that may include 24/7
EA License No : 19C9587
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