GxP Specialist

Role overview

GxP Specialist at Zifo RnD Solutions

Required qualifications

• Requirements Skills Required

Employment details

• Location: Chennai [Tamil Nadu] [India]

About the employer

• 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.

Benefits

• Zifo offers a competitive compensation package including earned leaves, paternity and maternity leaves, gratuity, health insurance covering spouse and children.

Additional role details

• 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.
• 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.
• 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.