Sanofi is hiring for the position of Quality Assurance Specialist at its Goa Site in Verna Industrial Estate, Salcete, Goa. The role is part of Manufacturing & Supply and focuses on quality systems, IPQA, validation, batch record review, GMP compliance, and shopfloor quality governance.

Job Details

Positions

Sanofi has listed Quality Assurance Specialist positions for its Verna, Goa site under the following job requisition IDs:

• R2873750
• R2873747
• R2873748

Responsibilities

Quality Systems Management

• Compilation, review and management of Product Quality Reviews.
• Coordination of change controls and management of the change control system.
• Management of deviations, market complaints, training systems and CAPA.
• QA focal point for OOS/OOT management.
• Nitrosamine assessment and review.
• Management of ICH Q3D requirements.
• Implementation of Sanofi Global Standards and Global Operating Procedures.
• Management of subcontractors and service providers.
• Management of process, cleaning, transport and computerized system validation.

Quality Management Systems

• Coordinate self-inspections and associated activities.
• Review and approve GxP documents, batch manufacturing records and batch packing records.
• Manage SOPs and master documents.
• Coordinate cGMP training activities.
• Initiate, implement and close change controls.
• Support deviation and market complaint investigations.
• Implement assigned CAPAs and Efficiency Reviews.
• Support batch release and respond to QP queries.
• Manage data integrity aspects.
• Handle the Site Master File.
• Review calibration documents.
• Conduct user access management and review.
• Perform audit trail review.
• Manage document archival and retrieval.

Validation & Qualification

• Act as the quality focal point for process, cleaning, transport and computerized system validations.
• Support qualification activities.
• Coordinate temperature and relative humidity mapping.
• Support hold-time and campaign-length studies.
• Act as quality focal point for utilities and purified water systems.
• Manage the Site Qualification & Validation Master Plan.

In-Process Quality Assurance

• Review and approve Master Batch Records and executed Batch Records.
• Review and approve logbooks.
• Perform line clearance in production.
• Conduct in-process checks.
• Perform product sampling during routine production and validation.
• Provide quality oversight on the shopfloor.

HSE Responsibilities

• Adhere to health, safety and environmental requirements.
• Support implementation of HSE systems and safe working conditions.
• Conduct daily safety training during +QDCI meetings.
• Support continuous improvement of workplace safety.
• Review implemented procedures periodically.
• Train personnel on safety and job-related requirements.

Eligibility & Qualifications

Candidates should meet the following requirements:

• Qualification: B.Pharm or M.Pharm
• Experience: 2 to 5 years
• Technical experience: IPQA, batch record review and shopfloor quality governance
• Languages: English, Hindi, Konkani and Marathi
• Working requirement: 3-shift working

Required Skills

Key areas relevant to the Quality Assurance Specialist role include:

• IPQA
• Batch Record Review
• Shopfloor Quality Governance
• Quality Management Systems
• GMP and GxP documentation
• Deviations, CAPA and Change Control
• Validation and Qualification
• Data Integrity
• OOS/OOT Management
• Audit Trail Review

Application Details