Quality Assurance Specialist

Job DescriptionJob Title: Quality Assurance Executive No of Vacancy: 1 Job Location: Mira Road/Wada/Boisar/ Kerala Years of Experience: 1-4 years Working Days: Monday to SaturdayJob Purpose: We are looking for a detail-oriented and committedQuality Assurance Executiveto support and enhance ourQuality Management System (QMS)in compliance withISO 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: Bachelor's and/or Master’s degree inPharmaceutical Sciences ,Engineering ,Biotechnology ,Microbiology , or any relevantLife Sciencesdiscipline. Specialization inRegulatory AffairsorQuality Assuranceis preferred.Key Skills & Competencies: Strong understanding ofISO 13485and21 CFR 820requirements Knowledge ofMDSAPstandards is a plus Excellentdocumentation practicesandscientific writing skills Familiarity withinternal auditrequirements;Internal Auditor certificationpreferred Good presentation and communication skills Ability to collaborate withcross-functional teamsProfessional Experience: 1 to 4 years of hands-on experience inQuality Assurancewithin a regulated industry such asMedical Devices ,Pharmaceuticals , orLife Sciences Proven experience in: Preparing and maintainingSOPs, Work Instructions , and other QMS documentation Managingdocument controland maintaining regulatory records Participating ininternal and external audits SupportingCAPA ,complaint handling , andfeedback mechanisms Assisting insupplier evaluation , communication, and audit coordinationKey Responsibilities: Develop and maintainStandard Operating Procedures (SOPs)andWork Instructionsin alignment with regulatory standards Ensure properdocument and record controlin accordance with ISO 13485 and other applicable quality standards Participate inquality audits(internal and external) and assist in audit readiness activities Identify and implementcorrective and preventive actionsto address non-conformities Conductroot 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 improvingfeedback and complaint handling systemsSoft Skills & Attributes: StrongEnglish proficiency– verbal and written Go-getter attitudeand self-motivated Willingness tolearn, lead , and take initiative Strong sense ofaccountability and integrity Excellentteam collaborationand interpersonal skills Ability to work effectively under guidance as well as independently Monday to Saturday working Company Website:

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