Track Lead - Qualification Protocols (IQ/OQ/PQ)

Experience: Not Available to Not Available years

Location: Banglore, India

Skills: ITIL, Computer system validation, Servicenow, HP ALC, MS-Office, IT Risk assessment, GxP experience, Validation documentation, Azure DevOps, Vendor management, Stakeholder management, CSV, Compliance, Qualification, TIMS, ADO

Job Summary
Skill Area: Validation and Compliance
• Main Technology: ITIL, Computer system validation: Tools -> Servicenow (eg ITOM), HP ALC, MS-Office
• Mandatory Skills: (Must Have Skills) –, IT Risk assessment, Periodic reports, GxP experience, Validation documentation (IV, OV, PV etc)
• Optional Skills: (Good to Have Skills) – Azure DevOps, Vendor mgmt, Stakeholder mgmt
• Roles & Responsibilities:
Responsible for preparing the Change & Release plan, driving all the Change & release related activities.
Preparing the implementation plan, participating in the impact assessment meetings, updating & review of URS, FS, DS & other relevant impacted documents.
Drive the change and validation activities required for the release.
Authoring, reviewing and approving of test cases, test protocols for verification and executing them as needed.
Authoring/Reviewing IT requirement risk assessment (ITRR), Test coordination / Validation and Defect Management etc, meeting the Quality & Compliance requirements as per company QMS procedures and regulatory guidelines.
Preparing/Updating IT Risk Assessment, supplier assessment, O&M; document etc. as needed.
IT service mgmt. activities such as change mgmt., incident mgmt. etc.
Keep Audit Checklist up & other compliance documents up to date
Act as system manager backup as needed

• Service Type: Compliance team support
• Skill Area: CSV, Compliance Gxp, Infrastructure support
• Main Technology: Compliance
• Mandatory Skills: (Must Have Skills)



- GxP, Compliance , CSV knowledge, Qualification and Maintenance
• Optional Skills: (Good to Have Skills) - Tools exp – TIMS, ADO, Servicenow
• Roles & Responsibilities: QC
Key Responsibilities
Skill Area: Validation and Compliance
• Main Technology: ITIL, Computer system validation: Tools -> Servicenow (eg ITOM), HP ALC, MS-Office
• Mandatory Skills: (Must Have Skills) –, IT Risk assessment, Periodic reports, GxP experience, Validation documentation (IV, OV, PV etc)
• Optional Skills: (Valuable to Have Skills) – Azure DevOps, Vendor mgmt, Stakeholder mgmt
• Roles & Responsibilities:
Responsible for preparing the Change & Release plan, driving all the Change & release related activities.
Preparing the implementation plan, participating in the impact assessment meetings, updating & review of URS, FS, DS & other relevant impacted documents.
Drive the change and validation activities required for the release.
Authoring, reviewing and approving of test cases, test protocols for verification and executing them as needed.
Authoring/Reviewing IT requirement risk assessment (ITRR), Test coordination / Validation and Defect Management etc, meeting the Quality & Compliance requirements as per company QMS procedures and regulatory guidelines.
Preparing/Updating IT Risk Assessment, supplier assessment, O&M; document etc. as needed.
IT service mgmt. activities such as change mgmt., incident mgmt. etc.




Keep Audit Checklist up & other compliance documents up to date
Act as system manager backup as needed

• Service Type: Compliance team support
• Skill Area: CSV, Compliance Gxp, Infrastructure support
• Main Technology: Compliance
• Mandatory Skills: (Must Have Skills) - GxP, Compliance , CSV knowledge, Qualification and Maintenance
• Optional Skills: (Good to Have Skills) - Tools exp – TIMS, ADO, Servicenow
• Roles & Responsibilities: QC
Other Requirements
Skill Area: Validation and Compliance
• Main Technology: ITIL, Computer system validation: Tools -> Servicenow (eg ITOM), HP ALC, MS-Office
• Mandatory Skills: (Must Have Skills) –, IT Risk assessment, Periodic reports, GxP experience, Validation documentation (IV, OV, PV etc)
• Optional Skills: (Good to Have Skills) – Azure DevOps, Vendor mgmt, Stakeholder mgmt
• Roles & Responsibilities:
Responsible for preparing the Change & Release plan, driving all the Change & release related activities.
Preparing the implementation plan, participating in the impact assessment meetings, updating & review of URS, FS, DS & other relevant impacted documents.
Drive the change and validation activities required for the release.
Authoring, reviewing and approving of test cases, test protocols for verification and executing them as needed.
Authoring/Reviewing IT requirement risk assessment (ITRR), Test coordination / Validation and Defect Management etc, meeting the Quality & Compliance requirements as per company QMS procedures and regulatory guidelines.
Preparing/Updating IT Risk Assessment, supplier assessment, O&M; document etc. as needed.
IT service mgmt. activities such as change mgmt., incident mgmt. etc.
Keep Audit Checklist up & other compliance documents up to date
Act as system manager backup as needed

📌 Track Lead Qualification Protocols (IQ/OQ/PQ) (Mumbai)
🏢 HCL Technologies
📍 Mumbai