Alkem Laboratories
Assistant Manager Internal Auditor IT Systems Alkem Overview
Alkem Laboratories is inviting applications for the Assistant Manager Internal Auditor IT Systems Alkem position at its Taloja facility in Navi Mumbai, Maharashtra. This full-time opportunity is designed for experienced professionals who can independently assess, monitor, and enhance compliance of GxP computerized systems and IT infrastructure while ensuring data integrity, regulatory compliance, system reliability, and inspection readiness.
The Assistant Manager Internal Auditor IT Systems Alkem role offers an opportunity to work closely with quality, IT, validation, cybersecurity, and compliance functions within one of India’s leading pharmaceutical companies.
Assistant Manager Internal Auditor IT Systems Alkem Summary
| Particulars | Details |
|---|---|
| Job Title | Assistant Manager – Internal Auditor – IT Systems |
| Company | Alkem Laboratories |
| Job Code / Reference Number | ALL-76463 |
| Employment Type | Full Time |
| Location | Taloja, Navi Mumbai, Maharashtra, India |
| Vacancies | 1 Position |
| Experience Required | 8 – 10 Years |
| Application Closing Date | 03 July 2026 |
| Application Mode | Online |
| Industry | Pharmaceuticals |
| Function | Internal Audit, IT Compliance, Quality Systems |
Assistant Manager Internal Auditor IT Systems Alkem Responsibilities
The primary objective of this role is to independently assess, monitor, and enhance compliance of GxP computerized systems and IT infrastructure with applicable regulatory requirements and internal quality standards.
Audit Planning and Execution
- Prepare annual and risk-based audit plans.
- Develop audit agendas and audit schedules.
- Conduct risk-based internal audits of IT systems supporting GxP activities.
- Create site-specific audit checklists and focus areas based on risk indicators.
- Lead audit opening and closing meetings.
- Document clear, concise, and evidence-based audit observations.
IT Systems Audit and Compliance
Evaluate and audit systems such as:
- LIMS
- Trackwise
- SAP
- SCADA
- LMS
Assess compliance with:
- 21 CFR Part 11 (ERES)
- EU GMP Annex 11
- GAMP 5 Guidelines
- ALCOA+ Data Integrity Principles
Review and assess:
- System controls
- Security controls
- Backup and disaster recovery procedures
- Audit trail functionality
Computerized System Validation (CSV) Review
Audit and review:
- User Requirement Specifications (URS)
- Functional Specifications (FS)
- Design Specifications (DS)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Validation reports
- Validation summary reports
Additional responsibilities include:
- Verifying validation status
- Assessing re-validation triggers
- Evaluating change control impacts on validated systems
Data Integrity Assessment
- Perform deep-dive data integrity audits.
- Verify audit trail review procedures.
- Review user access management controls.
- Assess electronic data lifecycle controls.
- Identify risks related to:
- Data manipulation
- Shared user accounts
- Inadequate audit trail reviews
IT Infrastructure and Security Review
Audit and assess:
- Server management (on-premise and cloud)
- Network security
- Backup and recovery systems
- Cybersecurity controls
- User access management
- Privileged account controls
- Segregation of duties
- Periodic access reviews
Audit Trail Review and Vendor Evaluation
- Verify that audit trails are enabled and secured.
- Evaluate audit trail review effectiveness.
- Review documentation practices.
- Audit software vendors, cloud providers, and CSV consultants.
- Assess quality agreements and data security controls.
Assistant Manager Internal Auditor IT Systems Alkem Requirements
Education Requirement
The employer has not specified educational qualifications on the career page.
Candidates with qualifications in the following disciplines may find this role relevant:
- Information Technology
- Computer Science
- Engineering
- Pharmaceutical Technology
- Life Sciences
- Related disciplines
Applicants should verify detailed eligibility requirements directly through the employer’s career portal.
Experience Requirement
- 8 to 10 years of relevant professional experience.
- Experience in pharmaceutical, healthcare, life sciences, manufacturing, quality systems, or regulated environments is preferred.
Skill Requirement
Key skills associated with the role include:
- Core Technical Skills
- SAP
- Trackwise
- IT Audit
- Computerized System Validation (CSV)
- Data Integrity
- GxP Compliance
- Regulatory Compliance
- Audit Trail Review
- Cybersecurity Controls
- Risk-Based Auditing
- User Access Management
- Vendor Audits
Assistant Manager Internal Auditor IT Systems Alkem Important Dates
| Event | Date |
|---|---|
| Opening Date on Employer Career Page | Not Mentioned |
| Application Closing Date | 03 July 2026 |
| Current Status | Applications Open |
Important: Since the application deadline is 03 July 2026, candidates should apply as early as possible to avoid last-minute technical issues or portal congestion.
About Alkem Laboratories
Founded in 1973, Alkem is one of India’s leading pharmaceutical companies with a strong global presence across more than 40 countries.
Key highlights include:
- 800+ pharmaceutical brands
- 19 manufacturing facilities
- 5 research and development centers
- More than 21,000 professionals globally
The company operates across major therapeutic segments including cardiology, oncology, gastroenterology, and several specialty healthcare areas.
About the Assistant Manager Internal Auditor IT Systems Alkem Role
The Assistant Manager Internal Auditor IT Systems Alkem role combines internal auditing, IT governance, compliance monitoring, cybersecurity assessment, computerized system validation, and regulatory readiness.
Professionals selected for this role will contribute to maintaining robust controls across critical pharmaceutical systems while supporting regulatory compliance and data integrity initiatives.
Who Should Apply for the Assistant Manager Internal Auditor IT Systems Alkem Role
This opportunity is suitable for professionals who possess:
- Experience in IT compliance and internal auditing
- Knowledge of GAMP 5, Annex 11, and 21 CFR Part 11
- Exposure to SAP, Trackwise, SCADA, LMS, or LIMS platforms
- Understanding of Data Integrity principles
- Experience in CSV documentation reviews
- Knowledge of cybersecurity and infrastructure controls
- Experience in pharmaceutical or regulated industries
Preparation Guide for Assistant Manager Internal Auditor IT Systems Alkem Applicants
Candidates preparing for interviews should strengthen their understanding of:
Regulatory Compliance
- 21 CFR Part 11
- EU GMP Annex 11
- GAMP 5
- ALCOA+ Principles
Technical Systems
- SAP Controls
- Trackwise Workflows
- LIMS Administration
- SCADA Environments
- Learning Management Systems
Validation and Quality
- CSV Lifecycle
- URS, FS, DS Documentation
- IQ, OQ, PQ Processes
- Change Control Systems
- CAPA Management
Audit Competencies
- Risk Assessment
- Root Cause Analysis
- Audit Reporting
- Vendor Qualification Audits
- Data Integrity Reviews
Assistant Manager Internal Auditor IT Systems Alkem Salary Insight
Alkem has not disclosed the salary for this vacancy.
Based on industry trends, professionals with 8–10 years of experience in pharmaceutical IT auditing, compliance, and validation functions generally receive competitive compensation packages that may include:
- Fixed annual salary
- Performance-linked incentives
- Health and insurance benefits
- Learning and development opportunities
- Career progression opportunities
Actual compensation will depend on qualifications, experience, and company policies.
How to Apply for Assistant Manager Internal Auditor IT Systems Alkem
Interested candidates can apply online through the official application portal:
Application URL:
Before submitting an application, candidates should ensure their resume highlights:
- IT Audit Experience
- GxP Compliance Exposure
- CSV Expertise
- SAP Experience
- Data Integrity Projects
- Regulatory Audit Experience
- Cybersecurity and Infrastructure Knowledge
Frequently Asked Questions
What is the job title?
The position is Assistant Manager – Internal Auditor – IT Systems.
What is the job code for this vacancy?
The job code/reference number is ALL-76463.
Where is the job located?
The position is based at Taloja, Navi Mumbai, Maharashtra, India.
How many vacancies are available?
There is one vacancy available for this position.
What experience is required?
Candidates should have 8 to 10 years of relevant professional experience.
Is this a full-time position?
Yes. This is a full-time role with Alkem Laboratories.
What is the last date to apply?
The application closing date is 03 July 2026.
Is SAP experience important for this role?
Yes. SAP is one of the systems specifically mentioned in the role responsibilities and is likely to be beneficial for applicants.
Does the role involve Data Integrity audits?
Yes. Conducting Data Integrity assessments and audit trail reviews is a key responsibility of the position.
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Key Takeaway
The Assistant Manager Internal Auditor IT Systems Alkem opportunity is suitable for experienced professionals specializing in IT audits, GxP compliance, computerized system validation, SAP, Trackwise, cybersecurity, and data integrity. With a closing date of 03 July 2026, eligible candidates should submit their applications early through the official Alkem careers portal.
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