Overview
Validation Specialist Jobs in Bangalore, Karnataka, India at AceNet
Job Summary:
We are seeking a highly skilled and experienced Validation Specialist to lead and execute the Computer Systems Validation (CSV) activities for IT systems used in pharmaceutical manufacturing environments.
Key Responsibilities
1.Validation Documentation:
* Author comprehensive Validation Plans, Test Plans, and Requirements Specifications.
* Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test scripts.
* Prepare and review detailed Test Execution, Test Reports, and Validation Reports.
2.System Validation and Deployment:
* Oversee global and local deployments of manufacturing IT systems, ensuring compliance with regulatory guidelines (e.g., FDA, EMA, GxP).
* Support system validation for new implementations, upgrades, and system modifications.
3.Compliance Management:
* Ensure all IT systems comply with applicable regulations, standards, and internal policies.
* Drive effective
change management
and handle deviation management processes.
4.
Testing and Quality Assurance:
* Collaborate with
cross-functional teams
to execute rigorous system testing and validation activities.
* Ensure traceability between requirements, test cases, and executed results.
5.Agile Practices (Preferred):
* Contribute to Agile methodologies and practices, supporting iterative system development and validation.
6.Stakeholder Engagement:
* Work closely with project teams,
Quality Assurance
, IT, and Manufacturing teams to ensure smooth project execution.
* Communicate effectively to report progress, issues, and compliance metrics.
Role Requirements and
Qualifications:
* Minimum 5 years of experience in CSV within the pharmaceutical industry.
* Proficient in authoring validation deliverables, including Validation Plans, Test Scripts (IQ, OQ, PQ), and Reports.
* Experienced with global and local deployments of manufacturing systems.
* Experience working in Agile environments or familiarity with Agile methodologies.
Title: Validation Specialist
Company: AceNet
Location: Bangalore, Karnataka, India
Category: IT/Tech, Quality Assurance – QA/QC
