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Quality Control Engineer

1 month ago

Bengaluru, India bigtec Private Limited Full time
Bigtec Labs is a wholly owned subsidiary and R&D arm of

Molbio Diagnostics , a global MedTech company that is a pioneer in IVD (in-vitro diagnostics). We design and develop pathbreaking diagnostic platforms that address clinical need gaps and can be deployed in Point-of-Care, resource-limited settings.Bigtec was established in the year 2000 in Bengaluru, the technology capital of India. We have grown to a multidisciplinary team of over 100 scientists and engineers, who excel in the translation of scientific ideas into market-ready products.Our Mission:

To develop cutting-edge products that enable precise, faster, cost-effective diagnosis at the Point-of-Care (POC)Our Vision:

To enable equitable access to healthcare by decentralization and democratization of diagnostic solutions

About the RoleWe are looking for a dynamic and detail-oriented professional with 3 to 5 years of relevant experience in Computer System Validation (CSV), GAMP 5, GxP, and Quality Assurance for software development. This role will not only focus on ensuring software quality but will also involve liaising with external agencies for GDPR implementation and establishing the role of a data manager within our organization.Key ResponsibilitiesComputer System Validation (CSV)Assist in developing, maintaining, and executing CSV protocols and reports in compliance with industry standards, including GAMP 5 and GxPEnsure validation documentation meets regulatory requirements and industry best practicesPerform risk assessments and maintain validation documentationSoftware Development Life Cycle (SDLC)Work closely with software development teams to understand project requirements and design test cases accordinglyMonitor and track software development processes to proactively identify potential quality issuesImplement and maintain quality control measures throughout the SDLCReview and validate software documentation and deliverablesGDPR Implementation and Data ManagementLiaise with external agencies to implement GDPR (General Data Protection Regulation) compliance measures within the organizationAct as a data manager, overseeing the collection, storage, and security of data in accordance with GDPR and other relevant regulationsEnsure data privacy and protection policies are in place and followedConduct regular audits of data management practicesDevelop and maintain data protection documentationRequired QualificationsBachelor's degree / postgraduate degree in any discipline2 to 4 years of relevant experience in software quality assurance, CSV, GAMP 5, GxP, and SDLCStrong analytical and problem-solving skillsExcellent communication and teamwork skillsAttention to detail and a commitment to delivering high-quality resultsPreferred QualificationsISTQB certificationKnowledge of industry standards and regulatory requirements pertaining to software quality, validation, and data privacy (GDPR)Experience with quality management systemsUnderstanding of data protection principles and practicesExperience in regulated industriesTechnical SkillsProficiency in quality management softwareKnowledge of validation tools and methodologiesUnderstanding of database management systemsFamiliarity with privacy impact assessmentsExperience with documentation management systems

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