ITQC Consultant - Bio Home (Hybrid)

Job Title -

ITQC Consultant - Bio Home

Job Type -

Hybrid

Experience

- 7+ Years

Job Description - Role Requirements for a senior or lead IT QC profile: As the

IT Validation & Compliance

you will join a collaborative team of eight validation specialists dedicated to continuously improving our IT validation approach. You will provide expert guidance on validation strategies for complex IT systems, ensuring compliance with regulatory requirements while enabling innovation in areas such as AI-driven solutions, software development, and automation scripting. You will play a key role in shaping IT validation frameworks for emerging technologies and supporting digital transformation.

Key responsibilities include: Lead Validation Activities:

Define and lead GxP and GDPR validation activities for BioHome. Process evaluation and contribution: contribute to the process improvement with the globalLIMS QC team Documentation & Compliance:

Develop and review validation documentation (protocols, reports, risk assessments) in alignment with regulatory guidelines. Lifecycle Management:

Partner with IT, Quality, and Business teams to have the IVs, OVs, PVs completed. Drive the ALM (TIMS) activities Cross-Functional Collaboration:

Serve as a vital bridge between PO, Developer, Tester, and Quality teams, facilitating effective communication and ensuring alignment every release. Audit Support:

Support internal and external audits/inspections and drive the implementation of the corrective / preventive measures.

Regulatory Knowledge:

Strong working knowledge of GxP regulations and industry standards such as GAMP 5, FDA 21 CFR Part 11, and EU Annex 11. GDPR knowledge is a plus Technical Proficiency:

Hands-on experience with HP ALM (TIMS), ADO, ServiceNow. drive test automation Communication Skills:

Excellent verbal and written communication skills Proactive Mindset:

A proactive approach with keen attention to detail. You take ownership of tasks and overall quality in BioHome area