Pharma IT, a ProductLife Group company, is searching for a Quality, Validation and Compliance Consultant to support our customers in validation and compliance work within the Pharma, Biotech, and Medical Device Industries.

Depending on your experience level and the complexity of the project, you will either work alone or under the guidance of a more experienced Compliance Manager. Consequently, functions can also include support to Senior Compliance Managers, as well as coordination and communication for validation activities.

This position presents large opportunities for growth, as you will be given greater responsibility over time.

For this role, it is essential that you have knowledge and experience from projects that use the V-Model and GxP. System validations will span from pure IT to laboratory equipment and pharmaceutical production equipment. Furthermore, the job is expected to be executed in accordance with internal and international guidance such as GAMP.

Key Job functions: Coordination, Quality Control, Reports, and Reviews

Group 10

As a IT Quality, Validation and Compliance Manager you are expected to:

  • Validate Computer Systems/Software Validation Procedures to ensure current regulatory compliance is met
  • Identify and mitigate risks
  • Prepare and execute validation protocols and reports
  • Provide IT support and assessment for relevant quality deviations
  • Recommend and manage corrective and preventive actions (CAPAs) to improve IT compliance
  • Author SOPs and Work Instructions compliance of IT systems
  • Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new IT projects throughout the project lifecycle

Group 12
Background and Experience

To be successful in the role of Quality, Validation and Compliance Manager, you will be expected to have:

  • A bachelor’s degree or higher
  • minimum of 3-5 years of experience within the Pharmaceutical, Biotech or Medical Device Industries, as well as experience with test and validation
  • An attentive and detail-oriented approach, as well as the ability to independently resolve a variety of issues without close supervision
  • Good organizational and planning skills
  • The ability to work collaboratively and as part of a team
  • Excellent English communication skills (verbal, written, and interpersonal)

971 - Compliance Consultant