Assistant Manager - IT GMP Operations (QA IT Preferred)

Alembic Pharmaceuticals Limited is hiring for the Sr. Executive / Assistant Manager to join our IT GMP Operations team for Vadodara Location. Candidates with QA IT experience are welcome to apply. The role involves managing IT compliance, data security, and integration of QC and manufacturing systems while meeting regulatory standards.

Key Responsibilities:

• Manage Quality IT activities for QC and manufacturing systems, including user management, data security, IT compliance, and implementation of data security policies.
• Handle QA IT systems, Including Chromeleon, Empower, Lab Solutions, and other QC standalone systems.
• Conduct infrastructure qualifications and implement/configure QC and manufacturing systems (e.g., data security policies, privilege matrix, database configurations).
• Support integration of manufacturing equipment with IT systems.
• Ensure compliance with IT SOPs and regulatory frameworks, including 21 CFR Part 11, Annexure II, GAMP 5, and PICS.
• Manage domain controllers, data backup processes, and security policies across GXP/GMP systems.
• Prepare for and assist in regulatory audits such as USFDA and others.
• Collaborate across teams with excellent communication skills to drive compliance and efficiency.

Qualifications and Skills:

• 8 to 12 years of proven experience in QA IT roles or IT GMP Operations.
• Strong knowledge of Chromeleon, Empower, Lab Solutions, and other QC systems.
• Experience in facing USFDA / Other Regulatory audits.
• Leadership skills to manage the teams.
• Expertise in IT compliance and regulatory standards (21 CFR Part 11, GAMP 5).
• Hands-on experience with Infrastructure qualification and manufacturing system integration.
• Knowledge of data security policies and privilege matrix setup in GXP/GMP environments.
• Strong communication and documentation skills, with prior experience facing regulatory audits.

Interested candidates with relevant experience in QA IT or IT GMP Operations can send their CVs to Itcv@alembic.co.in Please mention " IT GMP Operations" in the subject line of the email.