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Otsuka Pharmaceutical
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Manager-Computer System Validation - Otsuka Pharma MNC, Ahmedabad

Manager-Computer System Validation - Otsuka Pharma MNC, Ahmedabad

Otsuka Pharmaceutical

10 - 15 years

|

8 - 18 Lacs

Posted:19 hours ago| Platform:

Apply

Skills Required

capa csv computer system validation 21 cfr part 11

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities:

Lead CSV strategy and validation roadmap for GxP computerized systems.
Define validation approaches based on risk, system criticality, and regulatory requirements.
Plan and manage CSV activities for new system implementations, upgrades, and changes.
Ensure systems comply with 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity ALCOA+ principles, and company QMS.
Lead audits related to CSV (regulatory inspections and internal/external audits).
Address observations and CAPAs related to computerized systems.
Maintain validation master plans, SOPs, policies, and templates for CSV.
Approve technical documentation prepared by team members and vendors.
Ensure timely closure of deviations, CAPAs, and audit actions.
To prepare, execute and maintain Computer System Validation documents and PLC/SCADA Qualification documents.
Develop the validation test scripts and executing test scripts according to scenarios.
Prepare qualification protocol and execution as per protocol.
QMShandling,TrainingManagementinLMS etc.

Preferred candidate profile:

Knowledge of cybersecurity for GxP environments.
Experience in computerized equipment qualification.
Exposure to Annex 11 and FDA inspection handling.

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Otsuka Pharmaceutical

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