Lab IT Systems Administrator

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.

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