QA - Qualification And validations (Biosimilars)

Role & responsibilities

Executive / Sr. Executive QA (Qualification & Validation)

Department: Quality Assurance
Business: Biotech / Biologics
Experience: 48 Years
Location: Hyderabad

Job Purpose

To execute and oversee qualification and validation activities for Biotech/biologics manufacturing facilities, utilities, equipment, systems and processes in compliance with GMP, regulatory requirements and company quality systems.

The incumbent will be responsible for planning, reviewing, executing and documenting qualification and validation activities while ensuring compliance with approved procedures, protocols and regulatory expectations.

Key Responsibilities

Qualification & Validation

• Plan, coordinate and execute qualification activities for equipment, systems, utilities and facilities.
• Prepare, review and execute qualification protocols and reports, including:
• URS User Requirement Specification
• DQ Design Qualification
• IQ – Installation Qualification
• OQ – Operational Qualification
• PQ – Performance Qualification
• Support qualification of critical biotech manufacturing and laboratory equipment.
• Coordinate qualification activities with Engineering, Production, QC, R&D and other cross-functional teams.
• Review qualification documentation and ensure completeness, accuracy and GMP compliance.
• Ensure qualification activities are performed as per approved protocols and established timelines.

Process Validation

• Support/execute process validation and continued process verification activities for biotech manufacturing processes.
• Review process validation protocols, reports and associated supporting documents.
• Coordinate collection and review of process validation data.
• Ensure deviations observed during validation activities are appropriately documented, investigated and closed.

Cleaning Validation

• Support execution and review of cleaning validation activities.
• Review cleaning validation protocols, sampling plans and reports.
• Ensure acceptance criteria, sampling methods and analytical requirements are appropriately defined.
• Coordinate with Production and QC for validation sampling and testing.

Computerized System Validation

• Support qualification/validation of computerized systems used in GMP operations.
• Review validation documentation such as URS, risk assessments, functional specifications, test scripts and validation reports, as applicable.
• Ensure data integrity and GMP requirements are incorporated into computerized system validation activities.

Utilities & Facility Qualification

• Support qualification of critical utilities such as:
• HVAC
• Purified Water / WFI systems
• Compressed air
• Clean gases
• Steam systems
• Temperature-controlled systems
• Cleanrooms and controlled environments
• Review environmental and utility qualification data as applicable.
• Support periodic requalification activities.

Documentation & QMS

• Prepare/review validation-related SOPs, protocols, reports, forms and other controlled documents.
• Initiate and/or review deviations, CAPA, change controls and risk assessments associated with qualification and validation activities.
• Ensure proper documentation in accordance with Good Documentation Practices (GDP) and data integrity requirements.
• Maintain qualification and validation status trackers and periodic review schedules.
• Ensure timely closure of validation-related observations and commitments.

Audits & Regulatory Compliance

• Support internal audits, customer audits and regulatory inspections.
• Provide qualification and validation documentation during audits/inspections.
• Ensure compliance with applicable GMP, WHO-GMP, US FDA, EU GMP and other regulatory requirements, as applicable to the site and markets.
• Participate in inspection readiness and remediation activities.

Biotech/Technical Exposure

Preferred experience in qualification/validation of:

• Bioreactors / Fermenters
• Media and Buffer Preparation Systems
• Chromatography Systems
• Filtration Systems
• Autoclaves
• CIP/SIP Systems
• Lyophilizers, where applicable
• Cold Rooms / Freezers
• HVAC and cleanrooms
• Purified Water / WFI systems
• Clean Utilities
• Laboratory equipment
• Manufacturing and process equipment