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MS&T Consultant

NNIT A/S

Opret en karriereprofil og deltag i lodtrækningen om ét gavekort på 2.000 kr til LETZ SUSHI!

Responsibilities:

  • Perform risk-based qualification and validation of pharmaceutical and biopharmaceutical laboratory equipment, utilities, process and enterprise system.
  • Develop risk assessment, system impact assessments, protocols and reports that support qualification and validation in pharmaceutical environment.
  • Develop validation protocols using a risk-based approach that meets regulatory requirements and industry best practices.
  • Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.
  • Investigate deviations, write investigation reports and create summary reports.
  • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Professional Skills and Experience:

  • At least Bachelor’s degree in technical discipline such as Microbiology, Biochemistry, Chemistry or with experience relevant to the Job Description. Graduates of related discipline may also apply.
  • 4 or more years of experience in hands-on/ qualify QC laboratory equipment (Microplate Reader, UV Spectrophotometer, HPLC, FTIR, Portable Microbial Air Sampler, Total Particle Counter, Filtration system for Bioburden, Rapid Sterility Temperature System, pH meter, balances) or any combination thereof in pharmaceutical industry.
  • Experience in hands-on/ qualify system operating with Empower, Chromeleon, OpenLab, WinkQCL or any combination thereof in pharmaceutical industry.
  • Experience in operating Laboratory Information Management System (LIMS) and ability to troubleshoot the system will be an added advantage.
  • Good understanding of ICH Q7, ICH Q8, ICH Q9, ISO 14644, ANSI Z1.4 and other regulatory requirements (FDA, EMA, CFDA, etc.).
  • Preferably with advanced technical knowledge in one or more discipline.
  • Preferably with understanding of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.
  • Preferably with experience interacting with or creating material for management and regulatory agencies.
  • Experience with investigations into laboratory and / or manufacturing deviations and determination of product impact potential, root cause and corrective/preventive actions.

Offering:

  • Consulting roles for international healthcare clients in strategically relevant projects.
  • Work in a professional consultancy environment within a highly motivated team.
  • Opportunity to take on responsibility and to help shape our organization.
  • Excellent career development and growth opportunities in a growing premier consulting organization.
  • Structured training program and peer mentoring system to support competence and personal growth.

Location: Singapore

Application deadline: 21 May 2021

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Ansøgningsfrist d. 21.05.2021
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Opslagstype
Graduate/trainee
Geografi
Udlandet (øvrige)
Uddannelse
Kemi, Biotek & Materialer
Teknik & Teknologi
Arbejdsområde
Data & analyse
Forskning & Udvikling
Medicinal & Sundhed
Naturvidenskab
Rådgivning & Support
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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.

Placering
Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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