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MS&T Consultant (Junior Consultant)

NNIT A/S


MS&T Consultant (Junior Consultant)

We are looking for MS&T Consultant (Junior Consultant) to join our fast-growing team of specialists in Singapore.
You will:

  • Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities and process. Systems may include any or all of the following - secondary manufacturing facilities (sterile parenteral or oral dosage forms); chemical API manufacturing process; biopharmaceutical (upstream and downstream) manufacturing process; CIP; SIP; clean steam; HVAC; purified water; WFI system; laboratory equipment (e.g., GC-MS, HPLC).
  • Executed / develop validation protocols using a risk-based approach that meets regulatory requirements and industry best practices.
  • Develop risk assessment, system impact assessments, protocols and reports that support the qualification and validation of various kinds of systems.
  • Be part of the team that review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.
  • Be part of the team that investigate deviations, write investigation reports and create summary reports.

Your qualifications and experience
You have:

  • At least Bachelor’s degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description. Graduates of related discipline may also apply.
  • 0 to 4 years of experience in CQV, quality systems, quality operations, manufacturing, engineering, technology transfer and/or any combination thereof in pharmaceutical industry
  • Fresh graduate with relevant internship experience in pharmaceutical industry will be considered.
  • Familiarity of ICH Guidelines and other relevant regulatory experience.
  • Preferably with have experience in one or more CQV discipline (such as process equipment, laboratory equipment, cleaning, sterilization).
  • Preferably with good knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.

Excellent communication skills are required, since you will be working with internal NNIT Singapore’s Subject Matter Experts (SME), internal colleagues and client stakeholders. You must be able to communicate complex technical issues to management and other stakeholders.

Please submit your application and resume in English and attach relevant diplomas.

Location: Singapore



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NNIT A/S - hurtigt overblik


NNIT A/S
NNIT A/S
IT advisory, development and operations with a strong focus on life sciences, finance, the public sector and large enterprises with equally high demands on quality and security.

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Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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