QA - Qualification And validations (Biosimilars)

MSN Group; Hyderabad; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

MSN Group in Hyderabad is seeking an Executive / Sr. Executive QA (Qualification & Validation) to lead qualification, validation, and related GMP-compliant activities across biotech manufacturing facilities and utilities.

The role emphasizes planning, documenting, and coordinating with Engineering, Production, QC, and R&D to ensure approvals and timely completion.

Experience in biotech/biologics environments, strong documentation, and regulatory awareness are essential.

Qualifications

• Experience in qualification and validation activities for biotech/biologics facilities.
• Proficiency in GMP regulations and regulatory expectations.
• Strong documentation and record-keeping skills.

Responsibilities

• Plan, coordinate and execute qualification activities for equipment, systems, utilities and facilities.
• Prepare, review and execute qualification protocols and reports, including URS, DQ, IQ, OQ and PQ.
• Support qualification of critical biotech manufacturing and laboratory equipment.
• Coordinate qualification activities with Engineering, Production, QC, R&D and cross-functional teams.
• Review qualification documentation for completeness, accuracy and GMP compliance.
• Ensure qualification activities follow approved protocols and timelines.
• Support/execute process validation and continued process verification.
• Review process validation protocols, reports and data.
• Coordinate collection and review of process validation data.
• Ensure deviations are documented, investigated and closed.
• Support cleaning validation activities and reviews.
• Review cleaning validation protocols and sampling plans.
• Coordinate with Production and QC for validation sampling and testing.
• Support qualification/validation of computerized systems.
• Review validation documentation (URS, risk assessments, functional specs, test scripts, validation reports).
• Ensure data integrity and GDP compliance.
• Maintain status trackers and review schedules.
• Ensure timely closure of validation observations.

Skills

Quality Assurance

GMP Compliance

Documentation

Validation

Regulatory Audits

Job description

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