Assistant Manager - Sr. Executive || Vadodara (IT GMP Operations)

Alembic Pharmaceuticals Limited is hiring for the Assistant Manager/Sr. Executive 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.

Role & responsibilities :

🔹 Manage Quality IT activities for QC and Manufacturing systems
🔹 Oversee User Management, Data Security, and IT Compliance
🔹 Implement Data Security policies, Domain Controllers & Backup Management
🔹 Integrate Manufacturing equipment with IT systems
🔹 Ensure GXP/GMP Systems Data Security
🔹 Work with Chromeleon, Empower, SCADA, HMI & other Manufacturing applications
🔹 Handle IT Infrastructure Qualification & GxP Systems implementation
🔹 Ensure compliance with 21 CFR Part 11, Annexure II, GAMP 5, PICS
🔹 Prepare for and manage USFDA & other regulatory audits
🔹 Develop & enforce IT SOPs & compliance standards
🔹 Provide strategic leadership in IT GMP Operations

Preferred candidate profile

🔹Experience: 5 to 10 years in IT GMP Operations within the pharmaceutical industry
🔹Education: Bachelors or Masters degree in IT, Computer Science, or related field

🔹 Technical Skills:

• Strong knowledge of GxP/GMP Systems, IT Infrastructure, and Data Security
• Experience with Chromeleon, Empower, SCADA, HMI, and Manufacturing applications
• Expertise in User Management, Domain Controllers, Data Backup, and IT Compliance
• Regulatory Knowledge: 21 CFR Part 11, Annexure II, GAMP 5, PICS
• Soft Skills: Strong leadership, communication, and problem-solving skills
• Additional Advantage: Experience in USFDA and other regulatory audits

Interested candidates can share there profile At Itcv@alembic.co.in with the subject line

"IT GMP Operation"