Sr. Executive GMP IT, (Compliance)Airoli location

We are Hiring for

Sr. Executive GMP IT

The Sr. Executive GMP IT will be responsible for managing and supporting IT systems in a pharmaceutical manufacturing environment, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements. The role involves maintaining validated systems, supporting audits, and ensuring seamless IT operations aligned with industry standards.

Key Responsibilities:

• Manage and maintain GMP-compliant IT systems across manufacturing facilities.
• Ensure adherence to regulatory guidelines (FDA, EU, WHO) and data integrity principles.
• Participate in system validation activities (CSV) and maintain documentation as per GMP standards.
• Provide IT support for manufacturing applications such as LIMS, MES, SCADA, and ERP systems.
• Coordinate with cross-functional teams to ensure timely resolution of IT-related issues impacting production.
• Prepare and maintain SOPs, validation protocols, and audit documentation.
• Support internal and external GMP audits, respond to observations, and implement corrective actions.
• Monitor IT infrastructure performance and ensure compliance with cybersecurity and data integrity requirements.

Qualifications & Experience:

• Education:

  Bachelors degree in engineering (Computer Science, IT, Electronics) or related field.

• Experience:

  Minimum 4 years in IT within a pharmaceutical manufacturing environment.
• Hands-on experience with GMP systems and compliance requirements.
• Must have faced GMP audits and demonstrated ability to manage audit queries.
• Knowledge of Computer System Validation (CSV) and GAMP 5 guidelines.
• Familiarity with regulatory requirements (21 CFR Part 11, Annex 11).

Skills & Competencies:

• Strong understanding of GMP and IT compliance.
• Excellent problem-solving and troubleshooting skills.
• Good communication and documentation skills.
• Ability to work under pressure and meet timelines.

Preferred:

• Experience with pharma-specific applications (LIMS, MES, SAP).
• Certifications in IT compliance or CSV will be an added advantage.