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Healthcare Consultant

4 months ago

Chicago, United States PSRTEK Full time
Job DescriptionJob Description

Healthcare Consultant - Life science (Quality Management System)

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

Job Description

1. 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)

2. Consulting & Domain skills:

a. Strong understanding of QMS (Quality Management System) & SDLC (Software Development Life Cycle) processes in Life Sciences domain

b. Understanding of CSV / CSA (computer system validation/ computer system assurance) with cloud based/ digital systems

c. Experience on GAMP

d. Understanding of latest FDA and EMA guidelines

e. Exposure to Good practices (Clinical Manufacturing, lab and machine learning)

f. Understanding of impact on downstream projects and build practical approaches

g. Hands on experience writing SoPs, Work Instructions and templates.

h. Understanding of available quality automation tools in the market

3. Additional Skill & responsibility details:

a. 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.

b. Risk Management: - Identify, assess, and mitigate risks associated with processes, systems, and operations. - Develop and implement risk management plans and strategies.

c. Software Validation: - Review validation processes, protocols, plans, automation tools - Provide improvement recommendations for above

d. Training - Educate stakeholders and end users about the recommended CSA principles.

e. Assist in preparing, reviewing, and submitting documents & templates for above areas

4. Communication skills - Strong written and verbal communication skills

5. Years of Experience: 10-12 years.