Job Description

Roles & Responsibilities

As a Senior Quality Assurance Specialist, you will play a critical role in executing and maintaining quality assurance and validation activities to ensure full compliance with applicable regulatory requirements (e.g., ISO 13485, 21 CFR Part 11). The role ensures the validated state of products, processes, and systems, supports audit readiness, drives effective resolution of quality issues through CAPA, and contributes to continuous improvement initiatives, safeguarding product quality, data integrity, and overall compliance.

What You'll Do

• Execute validation and qualification activities for equipment, processes, products, and computerized systems (IQ/OQ/PQ/CSV), ensuring compliance with approved protocols and applicable regulatory requirements, including 21 CFR Part 11.

• Maintain the validated state by managing change control inputs, requalification activities, and data integrity requirements, ensuring full lifecycle traceability in accordance with ISO 13485.

• Implement and maintain QMS processes, including documentation control (creation, review, approval, distribution, and archiving), SOP development, and training coordination to ensure compliance with internal and external requirements.

• Conduct internal audits and support external audit readiness, including addressing findings, driving CAPA activities, and ensuring effective closure of nonconformities.

• Investigate quality issues, deviations, and nonconformities, perform root cause analysis, and collaborate cross-functionally to implement corrective actions and improve process performance.

• Establish and monitor quality control and acceptance activities across manufacturing and distribution to ensure product compliance with specifications and regulatory standards.

• Support supplier quality activities, including evaluation and auditing of suppliers and collaboration with procurement to resolve quality issues and drive improvements.

• Contribute to regulatory activities by providing QA input to product registrations and maintaining awareness of applicable regulatory updates.

• Drive continuous improvement initiatives using quality tools and methodologies (e.g., risk-based approaches, Six Sigma), enhancing product quality, system reliability, and operational efficiency under QA leadership.

• Adhere to the quality standards and safety procedures as per the company guidelines and local regulations.

• Take appropriate actions in relation to any hazards and work related issues, and escalate as needed, in order to ensure prompt and effective resolution.

• Perform other job-related tasks as assigned by the line manager, in order to ensure the fulfillment of organizational objectives.

Desired Candidate Profile

What To Bring

• Bachelor s degree in Chemistry, Biology, Pharmacy, Engineering, or a related field.

• 4 6 years of experience in validation and CSV within regulated industries (medical devices, pharmaceuticals, biotechnology, or FMCG).

• Strong understanding of QMS, GxP, validation, and CSV processes.

• Hands-on experience with ISO 13485 and FDA QSR requirements.

• Experience in CAPA, audits, and regulatory compliance.

• Good English communication skills.

• Familiarity with Six Sigma / Lean methodologies is a plus.

• ISO certification is a plus.