Validation and QA Specialist 1
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Work Mode: On-Site
Role Summary
The Validation and QA Specialist 1 is responsible for ensuring compliance, quality, and validation excellence across equipment, utilities, manufacturing processes, testing systems, and facility operations within a cGMP-regulated environment. The role focuses on establishing and maintaining validation programs, supporting facility start-up activities, ensuring regulatory compliance, and driving continuous quality improvement initiatives.
This position requires strong expertise in qualification and validation activities, risk assessment methodologies, quality management systems, and regulatory requirements to support successful product transfers, facility operations, and customer expectations.
Key Responsibilities
Validation & Qualification Management
Identify, plan, and implement validation requirements for:
Equipment
Instruments
Utilities
Manufacturing Processes
Testing Processes
Prepare, review, execute, and maintain:
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Protocols and Reports.
Coordinate and support:
Cleanroom Qualification
Facility Qualification
Utility Qualification Activities
Develop, maintain, and govern the Validation Master Plan (VMP).
Ensure validation documentation is maintained in a controlled and compliant manner.
Quality Systems & Regulatory Compliance
Review, approve, and maintain:
Validation Protocols
Standard Operating Procedures (SOPs)
Technical Documentation
Ensure compliance with:
cGMP Requirements
GAMP 5 Guidelines
FDA 21 CFR Part 11
ISO 9001 Standards
Ensure Quality Management System (QMS) adherence to organizational policies and regulatory expectations.
Support inspection readiness across validation and quality systems.
Risk Assessment, Deviations & CAPA Management
Assess validation changes and their impact on existing systems.
Investigate and manage:
Deviations
Non-Conformances
Compliance Issues
Perform:
Failure Mode and Effects Analysis (FMEA)
Impact Assessments
Risk Assessments
Lead root cause investigations and implement effective corrective and preventive actions (CAPAs).
Ensure timely remediation and closure of compliance actions.
Audit & Inspection Support
Lead and support:
Internal Audits
Customer Audits
Regulatory Inspections
Identify quality and compliance gaps through process audits.
Drive corrective actions and continuous improvement initiatives based on audit findings.
Ensure audit observations are effectively addressed and closed.
Cross-Functional Collaboration & Project Support
Collaborate with:
Production Teams
Maintenance Teams
Engineering Functions
Quality Teams
Global Project Stakeholders
Support:
Technology Transfer Activities
Product Transfer Projects
Facility Start-Up Initiatives
Work closely with suppliers, contractors, and service providers to achieve validation objectives.
Build strong cross-functional relationships to support project success.
Customer Quality Support
Serve as the primary quality representative for customers regarding product quality and validation matters.
Participate in customer discussions and quality reviews.
Address customer concerns related to quality and compliance requirements.
Support customer audits and qualification activities.
Data Analysis & Continuous Improvement
Conduct trend analysis of:
Validation Data
Non-Conformance Reports
Quality Metrics
Review data for compliance, accuracy, and process improvement opportunities.
Drive continuous improvement initiatives to enhance validation and quality processes.
Stay updated on industry trends, regulations, and best practices.
Environmental Health & Safety (EHS) Support
Support EHS and OSHA-related activities as required.
Ensure validation and quality activities are aligned with workplace safety requirements.
Promote a culture of quality, safety, and compliance across operations.
Required Qualifications
Education
One of the following qualifications:
Bachelor's Degree in Biotechnology
Master's Degree in Life Sciences
Master's Degree in Pharmaceuticals
Related Life Science or Engineering Degree
Experience
Minimum 6 years of total industry experience.
At least 5 years of experience in Validation and Quality Assurance roles.
Experience within:
Pharmaceutical Manufacturing Organizations
Biotechnology Companies
Research Institutes
Prior experience in:
Facility Start-Up Projects
Technology Transfer Programs
Validation Projects
is highly preferred.
Uttar Pradesh :
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Frank Scottile Blvd |Missouri :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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