Quality, Validation, and Compliance Manager
To support our customers, Pharma IT is searching for a Danish-based Quality, Validation and Compliance Manager to support validation and compliance work within the Pharma, Biotech, and Medical Device Industries.
For this role, it is essential that you have knowledge and experience from projects that use the V-Model and GxP. The 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.
Job functions – coordination, quality control, reports, and reviews
As Quality, Validation and Compliance Manager you are expected to:
- Validate Computer Systems/Software Validation Procedures to ensure that current regulatory compliance.
- 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.
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. Your responsibilities will, furthermore, grow over time, giving you greater responsibility of tasks related to our customers.
Your 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.
- 2-5 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 organisational and planning skills.
- The ability to work collaboratively and as part of a team.
- Excellent Danish and English communication skills (verbal, written, and interpersonal).
We're looking forward to hearing from you!
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