Quality Assurance Executive at Andheri
Quality Assurance Executive at Andheri
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Job Description
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:
Junior IC
Employment Type
Full-Time
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