Quality Assurance Executive at Andheri

Job Title: Quality Assurance Executive

No of Vacancy: 2

Job Location: Mira Road/Boisar

Years of Experience: 1-4years

Working Days : Monday to Saturday

Job Purpose:

We are looking for a detail-oriented and committed Quality Assurance Executiveto support and enhance our Quality Management System (QMS)in compliance with ISO 13485 21 CFR Part 820 and other applicable regulatory standards. This role involves document control audit support CAPA management and coordination with internal teams to ensure high-quality standards across operations.

Educational Qualifications:

Bachelors and/or Masters degree in Pharmaceutical Sciences Engineering Biotechnology Microbiology or any relevant Life Sciencesdiscipline.

Specialization in Regulatory Affairsor Quality Assuranceis preferred.

Key Skills & Competencies:

Strong understanding of ISO 13485and 21 CFR 820requirements

Knowledge of MDSAPstandards is a plus

Excellent documentation practicesand scientific writing skills

Familiarity with internal auditrequirements; Internal Auditor certificationpreferred

Good presentation and communication skills

Ability to collaborate with cross-functional teams

Professional Experience:

1 to 4 years of hands-on experience in Quality Assurancewithin a regulated industry such as Medical Devices Pharmaceuticals or Life Sciences

Proven experience in:

Preparing and maintaining SOPs Work Instructions and other QMS documentation

Managing document controland maintaining regulatory records

Participating in internal and external audits

Supporting CAPA complaint handling and feedback mechanisms

Assisting in supplier evaluation communication and audit coordination

Key Responsibilities:

Develop and maintain Standard Operating Procedures (SOPs)and Work Instructionsin alignment with regulatory standards

Ensure proper document and record controlin accordance with ISO 13485 and other applicable quality standards

Participate in quality audits(internal and external) and assist in audit readiness activities

Identify and implement corrective and preventive actionsto address non-conformities

Conduct root cause analysisas part of CAPA and complaint handling processes

Present periodic reports on QMS performance and effectiveness to the Quality Head/Management

Collaborate with internal departments to improve compliance and support continuous quality improvement

Assist in setting up and improving feedback and complaint handling systems

Soft Skills & Attributes:

Strong English proficiency verbal and written

Go-getter attitudeand self-motivated

Willingness to learn lead and take initiative

Strong sense of accountability and integrity

Excellent team collaborationand interpersonal skills

Ability to work effectively under guidance as well as independently

Monday to Saturday working

Company Website:

Experience:

Junior IC