Assistant Manager | Computerized system validation (CSV) | Pune | Cyber Strategy & Transformation

Deloitte & Touche GmbH Wirtschaftsprüfungsgesellschaft; Maharashtra; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Deloitte & Touche GmbH Wirtschaftsprüfungsgesellschaft in Pune is seeking an Assistant Manager to lead Computerized System Validation (CSV) within the Cyber Strategy & Transformation team. You will ensure regulatory compliance for GxP environments, including 21 CFR Part 11 and EU Annex 11, while applying SDLC/STLC practices and guiding change control and risk management with global leadership.

Responsibilities include validating software applications and computer systems, performing GxP

Qualifications

• Involved in Validation of Software Applications, Computer systems.
• Involved in GxP Analysis, Gap Assessment, ERES Assessment.
• Involved in Software Development Life Cycle (SDLC), Software Testing Life Cycle (STLC) and Testing methodologies.
• Involved in Software Quality Assurance and Risk Management.
• Involved in review of GAMP Guidelines.
• Ensuring that the entire project life cycle phases are compliant with Client's SDLC methodology Reporting Compliance status to Global leadership.
• Understand and ensure applicability of Computer System Validations for the complex change management environment as operating in regulatory compliance framework.
• Knowledge of 21 CFR Part 11 of USFDA, EU Annexure 11
• Experience in FDA regulated environment with good understanding of cGxP.
• Involved in assessments for GxP relevance and for 21 CFR Part 11 like ERES.
• Coordinate Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems.
• Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes.
• Support and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state.
• Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management.

Responsibilities

• There are no explicit job responsibilities stated in the HTML.

Skills

CSV Validation

GxP Analysis

SDLC/STLC

Quality Assurance

GAMP Guidelines

Change Control

Incident Management

21 CFR Part 11

EU Annex 11

Regulatory Compliance

CFR Part 11 / GxP

Education

BE/B.Tech (CS/IT/EC/E) or MCA

Job description

Job Title: Assistant Manager | Computerized system validation (CSV) | Pune | Cyber Strategy & Transformation

The team

Deloitte helps organizations prevent cyberattacks and protect valuable assets. We believe in being secure, vigilant, and resilient—not only by looking at how to prevent and respond to attacks, but at how to manage cyber risk in a way that allows you to unleash new opportunities. Embed cyber risk at the start of strategy development for more effective management of information and technology risks.

As an Assistant Manager professionalin ourCyberTeamyou’llbuild and nurture positive working relationships with teams and clients with the intention to exceed client expectations.

As a part of our Cyber strategy team, you will build and nurture positive working relationships with teams and clients with the intention to exceed client expectations.

Key Skills Required

• Involved into Validation of Software Applications, Computer systems.
• Involved in GxP Analysis, Gap Assessment, ERES Assessment
• Involved in Software Development Life Cycle (SDLC), Software Testing Life Cycle (STLC) and Testing methodologies.
• Involved in Software Quality Assurance and Risk Management.
• Involved in review of GAMP Guidelines
• Ensuring that the entire project life cycle phases are compliant with Clients SDLC methodology Reporting Compliance status to Global leadership
• Understand and ensure applicability of Computer System Validations for the complex change management environment as operating in regulatory compliance framework.
• Knowledge of 21 CFR Part 11 of USFDA, EU Annexure 11
• Experience in FDA regulated environment with good understanding of cGxP.
• Involved in assessments for GxP relevance and for 21 CFR Part 11 like ERES
• Coordinate Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems
• Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes
• Support and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state
• Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management
• Should have completed multiple varied end to end computer validation projects
• Experience in regulations such as 21 CFR Part 11 and EU Annexure 11 along with relevant regulatory requirements exposure
• Experience in GAMP 5 guideline, other relevant quality regulations-principles. GxP exposure
• A strong background on Quality systems such as CMMi or ISO
• Proven track record in validation and qualification of complex computer systems
• Demonstrable knowledge of GxP environments such as cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP standards, Part 820 and other relevant standards
• Educational Qualification: Any Graduate BE / B.Tech (Tier 1 / Tier 2) in CS / IT / EC / E, OR MCA from a recognized university