Quality Assurance Specialist

Why This Role Matters

In pharmaceutical manufacturing, quality is not just a function—it is a responsibility that directly impacts patient safety and public health. Every batch released to the market represents trust. Trust that processes were validated, systems were controlled, data was reliable, and compliance standards were met without compromise.
At the Goa manufacturing site of Sanofi, the Quality Assurance Specialist plays a central role in maintaining and strengthening the site’s Quality Management System (QMS). From deviation management and change control to validation oversight and batch release support, this role ensures that global standards and regulatory expectations are consistently upheld.
This position is ideal for pharmaceutical professionals who are disciplined, compliance-driven, and passionate about maintaining cGMP standards while contributing to continuous improvement initiatives.

Job Description

The Quality Assurance Specialist is responsible for managing and overseeing quality systems at the Goa manufacturing site. The role includes end-to-end management of product quality reviews, deviation handling, change control coordination, validation oversight, batch record review, and regulatory compliance activities.
The position acts as a QA focal point for multiple systems including OOS/OOT management, CAPA, training systems, market complaint investigations, validation programs, and global standard implementation.
The selected candidate will work cross-functionally with Production, Engineering, QC, PMTD, HSE, and global stakeholders to ensure that all manufacturing and quality operations align with cGMP requirements and global company standards.

Key Features of the Role:

• End-to-end exposure to pharmaceutical Quality Management Systems
• Direct involvement in validation, qualification, and compliance oversight
• Responsibility for deviation, CAPA, and change control systems
• Active role in batch record review and release support
• Interaction with global standards (STDs & GOPs) implementation
• Opportunity to contribute to data integrity and digital compliance initiatives
• Involvement in audit readiness and regulatory inspection preparedness

Responsibilities

1. Management of Quality Systems

• Compilation, review, and management of Product Quality Reviews (PQR)
• Act as site coordinator for change control management
• Manage deviation systems and support investigations
• Oversee Market Complaint investigations
• Act as QA focal point for OOS/OOT management
• Manage training systems and cGMP training coordination
• Oversight of Pest Control systems
• Perform Nitrosamine assessments and ICH Q3D compliance reviews
• Implement Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs)
• Manage subcontractor and service provider quality compliance
• Oversee validation systems (process, cleaning, transport, computerized systems)
• Manage CAPA systems and ensure timely closure

2. Quality Management Systems (QMS)

• Coordinate and conduct self-inspections as per annual planner
• Review and approve GxP documents, BMRs, and BPRs in electronic systems
• Manage SOPs, master documents, and document control systems
• Initiate and close change controls and deviations
• Support market complaint investigations
• Implement and monitor assigned CAPAs and Efficiency Reviews (ERs)
• Act as PPO for assigned Quality Maturity Index (QMI) processes
• Support batch release and respond to QP queries
• Manage data integrity aspects and audit trail reviews
• Participate in SMS and HSE initiatives
• Maintain Site Master File (SMF)
• Review calibration documentation (Engineering/QC/PMTD)
• Manage user access control and document archival systems
• Support analytical method creation

3. Validation & Qualification Oversight

• Act as quality focal point for all validation activities
– Process validation
– Cleaning validation
– Transport validation
– Computerized system validation
• Oversee temperature and relative humidity mapping
• Monitor hold time studies (products and equipment)
• Provide QA oversight for utilities and purified water systems
• Manage Site Qualification & Validation Master Plan

4. In-Process Quality Assurance (IPQA)

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

5. Health, Safety & Environment (HSE)

• Ensure adherence to all HSE policies and procedures
• Promote safe working conditions and continuous safety improvement
• Conduct daily training in +QDCI meetings to address unsafe conditions
• Encourage associate suggestions for safety improvements
• Review and evaluate implemented safety procedures
• Train personnel to ensure zero LTI and IWLT at the workplace

Required Qualifications

• B.Pharm or M.Pharm
• 2–5 years of experience in pharmaceutical Quality Assurance

Educational Requirements:

Bachelor’s or Master’s degree in Pharmacy from a recognized institution. Strong understanding of cGMP, regulatory guidelines, and pharmaceutical manufacturing practices is essential.

Experience and Skills:

Technical Competencies:
• Strong knowledge of cGMP requirements
• Experience in deviation, CAPA, and change control management
• Validation and qualification oversight experience
• Experience with electronic document management systems
• Understanding of data integrity principles
• Familiarity with regulatory guidelines (ICH, global GMP standards)

Core Skills:
• Strong analytical and problem-solving abilities
• Attention to detail and documentation accuracy
• Cross-functional coordination skills
• Audit readiness mindset
• Strong written and verbal communication skills

Salary Insights:

Compensation will be competitive and aligned with pharmaceutical industry standards. It will depend on experience, expertise in quality systems, and interview performance.
Additional benefits may include:
• Exposure to global quality systems
• Structured career growth within a multinational pharmaceutical environment
• Learning opportunities aligned with international regulatory standards

Company Overview

Sanofi is a global biopharmaceutical company focused on human health. The organization develops vaccines, innovative treatments, and solutions for rare diseases and chronic conditions. With operations across multiple countries, Sanofi integrates science, technology, and global expertise to deliver transformative healthcare solutions.
The company is committed to diversity, equity, and inclusion, ensuring equal opportunity regardless of race, religion, gender, nationality, disability, or identity. Sanofi fosters a culture where professionals from diverse backgrounds collaborate to drive scientific excellence and meaningful patient impact.

FAQs

Q1: Is prior QA experience mandatory?
Yes, 2–5 years of pharmaceutical QA experience is required.

Q2: Does the role involve shopfloor activities?
Yes, IPQA responsibilities include line clearance, in-process checks, and production oversight.

Q3: Is validation experience necessary?
Yes, oversight of validation and qualification systems is a key responsibility.

Q4: Does this role support batch release?
Yes, it includes review support and response to QP queries.

Q5: Are multilingual skills preferred?
Yes, knowledge of English, Hindi, Konkani, or Marathi is advantageous.

Application Tips

• Highlight deviation, CAPA, and change control experience clearly
• Mention validation and qualification exposure
• Emphasize shopfloor IPQA experience
• Demonstrate understanding of data integrity principles
• Showcase audit preparation or regulatory inspection involvement