Description

　　Company Overview: Join our client, a global leader in specialty generic pharmaceuticals, committed to providing high-quality, affordable medicines across 100+ countries. With a multicultural workforce and a strong emphasis on innovation, our client operates over 40 manufacturing facilities worldwide, supported by R& D centers boasting a team of 2,000 scientists. Join them in making a meaningful impact on healthcare, where excellence is fostered through cutting-edge solutions.

　　Job Summary: As an Applications-Focused Systems Administrator, you will play a pivotal role in managing day-to-day system administration, user support, and implementation of GxP Computerized Systems in their Quality Control Analytical Lab Manufacturing environments. Your expertise will contribute to maintaining compliance with industry standards and ensuring the seamless integration of technology into their critical pharmaceutical processes.

　　What you'll do:

　　Collaboration & Implementation

　　Work closely with business partners, instrument vendors, and IT team members to administer and support GxP applications and systems.

　　Manage GxP Systems Inventory, User Access Management, system implementation, retirement, backups, and recovery activities.

　　Collaborate with cross-functional teams to apply cGMP principles, internal SOPs, and regulatory requirements.

　　System Design & Validation

　　Provide support during new system implementations, overseeing design, configuration, and validation (IQ/OQ/PQ).

　　Ensure solutions meet business needs while adhering to IT policies, compliance standards, and GxP requirements.

　　Periodic Reviews & Compliance

　　Conduct periodic reviews to confirm computerized systems' compliance with company procedures and regulatory guidelines.

　　Assist in QMS processes, including change control impact assessments, CAPA execution, and managing deviations through root cause analysis.

　　Process Optimization & Automation

　　Propose alternate processes, procedures, and automation pathways to enhance IT operations' effectiveness and efficiency.

　　Visualize and contribute to the gradual implementation of automation and digitalization projects.

　　Global Collaboration & Audits

　　Collaborate with stakeholders globally to implement best GxP IT practices.

　　Support regulatory, customer, and other audits from the IT department.

　　Core Application Administration Functions:

　　User Access/Privileges

　　System Support

　　Strategic Functions:

　　Gradually progressing to implementing projects.

　　Evolving into a wider role with a focus on automation and digitalization.

　　Visualizing and contributing to the future of automation.

　　Join them in shaping the future of pharmaceutical technology, where your skills and expertise will impact healthcare on a global scale.

　　Requirements

　　Work Conditions: Manufacturing/Production/Laboratory environment with potential exposure to noise, fumes, odors, gases, dust, and other hazards. Physical requirements include lifting up to 50 lbs.

　　Travel Estimate: Up to 25% to other sites within North American geography and occasional vendor audits.

　　Education and Qualifications:

　　Minimum Bachelor's Degree, preferably in Life Sciences, Pharmacy, Computer Science, or related field.

　　Strong understanding of GAMP 5, 21 CFR Part 11, Computer System Validation, and Quality Management System.

　　Excellent collaboration and communication skills.

　　6-7+ years of hands-on experience in maintaining and administering GxP systems, applications, and instruments.

　　Technology Doesn't Change the World, People Do.®

　　Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.

　　Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more.

　　All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

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