Quality Engineering, QA Expert

? Location: Mumbai, Maharashtra, India

? Industry: Pharmaceutical Manufacturing

? Work Setting: Hybrid

Are you passionate about GMP compliance, quality-by-design principles, and influencing major capital investments from the earliest stages of development?

We are seeking an experienced QA Expert, Front End to serve as a strategic quality leader within the Global Quality Engineering (GQE) organization. This role ensures quality, compliance, and regulatory expectations are embedded into global growth initiatives and CAPEX programs from project conception through early design phases.

The ideal candidate combines deep GMP expertise, engineering project knowledge, qualification experience, and the ability to influence senior stakeholders to ensure quality and compliance are foundational elements of all major investment decisions.

Key Responsibilities

Quality Integration & Project Governance

Lead quality and compliance activities during the front-end phases of major capital projects.Ensure quality requirements are incorporated into project concepts, business cases, and design strategies.Partner with project teams to embed Quality-by-Design (QbD) principles into project planning.Provide quality oversight throughout project initiation and early-stage development.GMP Design Review & Compliance

Conduct comprehensive GMP design reviews of facilities, equipment, utilities, and technical specifications.Evaluate engineering designs against:FDA requirementsEMA requirementsInternational GMP standardsInternal quality standardsIdentify compliance risks and recommend mitigation strategies.Ensure projects are designed to meet future regulatory inspection requirements.Qualification Program Leadership





Support the strategic development of qualification programs for global investment projects.Ensure qualification strategies align with:Operational requirementsCustomer expectationsRegulatory compliance obligationsPlatform standardsProvide oversight for qualification planning and readiness activities.Guide project teams on validation and qualification expectations.Strategic Stakeholder Partnership

Collaborate closely with:Global EngineeringQuality OrganizationsManufacturing OperationsProgram ManagementExecutive LeadershipAlign quality expectations with business and capacity planning objectives.Influence project decisions through expert quality guidance.Act as a trusted advisor during project reviews and governance discussions.Risk Management & Compliance Assurance

Identify compliance gaps and quality risks during project planning and design phases.Develop recommendations that reduce regulatory, operational, and business risks.Support informed decision-making through risk-based quality assessments.Ensure projects remain aligned with regulatory expectations before execution begins.Data Integrity & Quality Systems

Promote and enforce data integrity principles across project activities.Assess project documentation and systems to ensure compliance with quality requirements.Identify opportunities to strengthen controls and governance processes.Support implementation of best practices for quality systems and documentation management.Stage Gate Quality Oversight

Gate -1: Expectations

Align quality strategy, stakeholder expectations, and organizational requirements.Ensure quality considerations are incorporated into project planning activities.Stage Gate 0: Ideation

Assess project concepts from a quality and compliance perspective.Validate strategic relevance and alignment with quality objectives.Stage Gate 1: Feasibility





Review business cases and technical feasibility studies.Confirm quality requirements are adequately reflected within proposed solutions.Stage Gate 2: Concept & Basic Design

Review and approve design concepts and CAPEX/OPEX proposals.Ensure designs support regulatory compliance and operational excellence.Continuous Improvement

Contribute to global quality engineering best practices.Support ongoing improvement initiatives within the Global Quality Engineering organization.Share lessons learned across projects and sites.Stay current with evolving GMP regulations, industry standards, and quality engineering methodologies.

Qualifications

Education

Bachelor's Degree in:EngineeringPharmaceutical SciencesBiotechnologyLife SciencesQuality ManagementRelated Technical Discipline

Preferred

Advanced degree in a scientific, engineering, or quality-related field.Skilled certifications in Quality, GMP, Validation, or Project Management.Experience

Extensive experience in:Pharmaceutical ManufacturingBiotechnologyGMP-Regulated EnvironmentsQuality AssuranceEngineering ProjectsCapital Project DeliveryExperience supporting:Facility DesignCommissioningQualificationValidationRegulatory Compliance ProgramsExperience participating in major CAPEX projects and engineering initiatives.

Core Competencies

Quality & Compliance

GMP ComplianceFDA & EMA RegulationsQuality AssuranceQuality by Design (QbD)Data IntegrityRegulatory Inspection ReadinessEngineering & Project Support

Capital Projects (CAPEX)Facility Design ReviewQualification StrategyValidation PlanningRisk ManagementEngineering Project GovernanceLeadership & Influence

Strategic Stakeholder ManagementCross-Functional CollaborationExecutive CommunicationQuality LeadershipDecision SupportChange ManagementTechnical Expertise

GMP Facility DesignCompliance Risk AssessmentTechnical Documentation ReviewQuality SystemsProcess ImprovementContinuous Improvement

📌 Quality Engineering, QA Expert (Mumbai)
🏢 SoTalent
📍 Mumbai