![No deviation Pte Ltd](https://media.trabajo.org/img/noimg.jpg)
Biotechnologist
3 weeks ago
- Incorporated in 2007, we are a patientcentric 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 valueadding commissioning, qualification, and validation services, we are leading experts in developing the lean CQV methodology. We extend our offerings to GMPcertified 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.
Responsibilities:
- Involve in handson execution of the plant operations and assist Manufacturing Associates in troubleshooting
- Monitor and analyze processing parameters for atypical trends and improvement opportunities
- Perform solution and equipment preparation
- Stage components for autoclaving and washing
- Support inprocess 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)
Requirements:
- NITEC/ITE/Diploma in Chemical, Pharmaceutical, Life Sciences or Bioprocessing 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 cleanroom 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 and willingness to work any shift in support of operations that may include 24/7
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