Healthcare Consultant - Life science (Quality Management System)
Healthcare Consultant - Life science (Quality Management System)
PSRTEK
Chicago, IL
See who PSRTEK has hired for this role
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.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Health Care Provider -
Industries
IT Services and IT Consulting
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