GxP Specialist

Skills Required

• Experience with Regulatory standards and deliverables.

• Proven track record in CSV with a strong understanding of CSV/SDLC practices.

• Excellent problem-solving, communication, and documentation skills.

• Multiple stakeholders management.

• Experience leading CSV for digital projects within Manufacturing and supply chain processes.

• Experience leading CSV for digital projects within SAP ERP or ICSM landscape.

Qualification / Requirement

• Bachelor’s Degree in Life Sciences, Information Technology, Engineering, or a related field.

• 5+ years of job-related experience in Computer System Validation.

About Zifo

Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals, Oil and Gas and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 11 of the Top 15 Biopharma companies.

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. A passion to learn and a spirit of teamwork characterizes us. We revere excellence and the value everyone brings. At Zifo, our culture is one where we debate, challenge ourselves and interact with all alike. If you share these sentiments and are prepared for the atypical, then Zifo is your calling!

Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate based on race, religion, colour, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Zifo offers a competitive compensation package including earned leaves, paternity and maternity leaves, gratuity, health insurance covering spouse and children.

The individual should serve as a Computer Systems Validation (CSV) expert, leading validation and testing for the SAP ICSM (Intelligent Clinical Supply Chain Management) solution. They should ensure that system functionalities are designed and implemented in accordance with regulatory expectations following the deployment of the SAP ICSM Cloud solution and the S/4 HANA add-on for ICSM. The individual will collaborate with cross-functional teams, including Digital, QC, QA, Infrastructure, and external vendors. They should possess strong customer communication skills and be capable of navigating project execution challenges involving multiple stakeholders.