PSRTEK

Healthcare Consultant - Life science (Quality Management System)

PSRTEK Chicago, IL
PSRTEK

Healthcare Consultant - Life science (Quality Management System)

PSRTEK Chicago, IL
1 month ago 37 applicants

See who PSRTEK has hired for this role

Onsite - Chicago, IL (3-4 days per week)

Job Description

  • Experience in Life Sciences consulting projects related to Quality (QMS), SDLC & Regulatory (e.g conducting “As-Is” Assessments, “To Be” State definition and Pilot execution)
  • Consulting & Domain skills:
  • Strong understanding of QMS (Quality Management System) & SDLC (Software Development Life Cycle) processes in Life Sciences domain
  • Understanding of CSV / CSA (computer system validation/ computer system assurance) with cloud based/ digital systems
  • Experience on GAMP
  • Understanding of latest FDA and EMA guidelines
  • Exposure to Good practices (Clinical Manufacturing, lab and machine learning)
  • Understanding of impact on downstream projects and build practical approaches
  • Hands on experience writing SoPs, Work Instructions and templates.
  • Understanding of available quality automation tools in the market
  • Additional Skill & responsibility details:
  • Regulatory Compliance: - Ensure all company processes and procedures comply with relevant regulations and standards, including FDA, EMA, and other applicable authorities. - Develop and maintain compliance documentation, policies, and procedures.
  • Risk Management: - Identify, assess, and mitigate risks associated with processes, systems, and operations. - Develop and implement risk management plans and strategies.
  • Software Validation: - Review validation processes, protocols, plans, automation tools - Provide improvement recommendations for above
  • Training - Educate stakeholders and end users about the recommended CSA principles.
  • Assist in preparing, reviewing, and submitting documents & templates for above areas
  • Communication skills - Strong written and verbal communication skills
  • Years of Experience: 10-12 years.

PSRTEK is a reputed technology recruitment and IT staffing brand with a global footprint and an admired client base. As an ideas and innovation powerhouse with a culture of excellence, we bring remarkable expertise and deliver powerfully transformative results.

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Health Care Provider

  • Industries

    IT Services and IT Consulting

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