GxP Specialist

Posted 2 Days Ago
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Chennai, Tamil Nadu, IND
In-Office
Senior level
Information Technology • Consulting
The Role
Lead Computer Systems Validation and testing for the SAP ICSM solution and S/4 HANA add-on, ensuring regulatory compliance. Collaborate with Digital, QC, QA, Infrastructure and vendors, manage multiple stakeholders, resolve project execution challenges, and maintain clear documentation and customer communication.
Summary Generated by Built In

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.


Requirements

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.

Skills Required

  • Experience with regulatory standards and deliverables
  • Proven track record in Computer Systems Validation (CSV) and strong understanding of CSV/SDLC practices
  • Excellent problem-solving, communication, and documentation skills
  • Experience managing multiple stakeholders
  • Experience leading CSV for digital projects within manufacturing and supply chain processes
  • Experience leading CSV for digital projects within SAP ERP or ICSM landscape
  • Bachelor's degree in Life Sciences, Information Technology, Engineering, or related field
  • 5+ years of job-related experience in Computer Systems Validation
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The Company
HQ: Chennai, Tamil Nadu
1,260 Employees
Year Founded: 2008

What We Do

Did you know that the saying ‘Curiosity killed the cat’ actually ends with ‘but satisfaction brought it back’? We suspect that the shortened version is the doing of grown-ups suppressing the innately curious child inside them! For us at Zifo, we take curiosity as unbounded - it is a celebrated value. Curiosity does wonderful things - drive exploration, accelerate learning, inspire better solutions, lead to innovation, drive conversations. We believe that the scientific community’s most important duty to the world is to stay curious. And this is what we do at Zifo. We have a global presence of over 1000 employees spread across our offices in US, UK, France, Germany, Switzerland, Japan, China, Canada, Singapore & India. We offer services in areas such as Scientific Informatics, Lab Informatics, Clinical Biometrics, Regulatory Compliance including Computer System Validation and Genome Informatics across 20+ countries. Our customers include 7 of the Top 10 global Bio-pharma companies. We are listed as 'Technology Fast 50'​ by Deloitte for 9 consecutive years (2012-2020) and as one of the 'Best Places to Work'​ for the past five years. We strive to stay curious, day in and day out. Asking the right questions, and listening to provide the right solutions. Write to us at [email protected].

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