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IT Compliance Analyst

2 months ago


Philadelphia, Pennsylvania, United States Lifelancer Full time
Position Overview:
Our Client is in search of an IT Compliance Analyst to join their team. This role can be performed remotely or from our designated site. The IT Compliance Analyst will focus on the analysis and validation of GxP applications, ensuring that all systems meet regulatory standards.

Key Responsibilities:
- Conduct thorough business analysis and validation for GxP applications.
- Collaborate with stakeholders to gather user requirements and document processes.
- Author validation documentation in accordance with the Software Development Life Cycle (SDLC).
- Manage change control activities to support system enhancements and user needs.

Qualifications:
- A background in biological sciences, chemistry, engineering, or a related field is preferred.
- Experience in a GxP regulated environment, particularly within the biopharmaceutical industry.
- Familiarity with Veeva Systems and Lab Information Management Systems (LIMS) is advantageous.

Essential Skills:
- Strong analytical skills to identify stakeholder needs and prioritize tasks effectively.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively within a dynamic team environment.
- Comprehensive understanding of GAMP 5 and regulatory requirements related to system validation.

Preferred Experience:
- Knowledge of Quality, Clinical, and Regulatory processes.
- Experience with Veeva Quality and Regulatory Vault, as well as LIMS validation.

We encourage interested candidates to explore this opportunity further.