
Advanced IT Professional for Pharmaceutical Manufacturing
2 days ago
IT Operations Manager - Pharmaceutical Manufacturing
We are seeking a skilled IT professional to manage all operations at our manufacturing plant, ensuring alignment with corporate standards and regulatory requirements.
Key Responsibilities:
- Manage IT operations and ensure compliance for manufacturing systems (MES, LIMS, SCADA, etc.)
- Act as primary contact for plant and quality assurance teams
- Support audits and inspections by regulatory bodies (FDA, EMA, etc.)
- Manage local infrastructure and coordinate with central teams
- Implement and monitor cybersecurity protocols
- Coordinate system rollouts and upgrades
- Maintain and update IT SOPs in compliance with GxP standards
- Collaborate with vendors and third-party providers
- Train and support end-users on relevant systems
Qualifications & Skills:
- Bachelor's degree in computer science or related field
- 3+ years of experience, including 2 years in pharmaceutical manufacturing
- Strong knowledge of regulatory requirements, including GxP, 21 CFR Part 11, and other applicable regulations
- Experience supporting or managing systems such as MES, LIMS, SCADA, or ERP in a regulated environment
- Familiarity with processes and system validation life cycle (SDLC)
- Strong troubleshooting, analytical, and communication skills
- Ability to manage projects and coordinate cross-functional teams
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