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Regulatory Analyst

CZ  ‐ Onsite
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Keywords

Compliance Audit Consulting Document Management Project Management Project Manager Change Management Manager

Description

This is a Regulatory Analyst role based in Prague. Candidates should reside in the Czech Republic.

Detailed Job Description:

As a Senior Consultant, you should have 10+ years of hands on experience on providing pharma regulatory compliance consulting to development projects with the following objectives,

  • Deliver ISRM services to the client they are part of to help ensure that information and IT systems are adequately protected against unauthorized disclosure (confidentiality), unauthorized alteration (integrity), unavailability (availability) and non-compliance
  • To ensure identified project methodology is followed and deliverables are produced in line with validation approach
  • Driving achievements of the Validation/Quality goals by ensuring that the process and standards defined for the project are followed

Mandatory Skillset:

  • GxP, 21 CFR Part 11, SDLC, GAMP knowledge and SOX knowledge
  • Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Computerized System Validation (CSV) concept
  • Preparation for compliance audit, attending meetings and assisting in addressing any issues. Also Supporting Project Manager in risk management activities
  • Able to manage direct relations with stakeholders and project team members.

    • Salt is acting as an Employment Business in relation to this vacancy.

    Start date
    ASAP
    Duration
    9-12 months
    From
    Salt
    Published at
    08.07.2020
    Project ID:
    1944321
    Contract type
    Freelance
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