Executive

1 week ago

India Biocon Full time

Department Details Role Summary Job Purpose To ensure the effective functioning maintenance and compliance of process and RND laboratory instrumentation and equipment The role involves CSV CQV Change control CAPA Deviation management QMS Validation calibration documentation audit support and cross-functional coordination in adherence to quality and regulatory standards Key Responsibilities Prepare review and execute CSV deliverables for new and existing enterprise scientific applications e g Unicorn Chromeleon Biacore Control LIMS laboratory instruments equipment and R D systems Develop and implement validation strategies in alignment with GAMP 5 21 CFR Part 11 and EU Annex 11 guidelines Perform risk assessments to identify and mitigate software-related risks impacting data integrity product quality patient safety and compliance Manage end-to-end validation for all software categories Category 1 3 4 5 in a regulated GxP environment Prepare IT Infrastructure Qualification documentation including for servers networks cloud environments and on-prem systems Execute periodic reviews of GxP computerized systems to ensure continued compliance and system suitability Manage QMS records such as Change Control CAPA and Deviation related to software and Instruments Equipment Perform vendor assessments GxP assessments and maintain traceability across the validation lifecycle Support system audit trail reviews user management backup restore validation and password access control procedures Prepare and maintain equipment qualification documentation IQ OQ PQ including calibration and Requalification Technical Functional Skills Strong knowledge of GAMP 5 21 CFR Part 11 EU Annex 11 and data integrity principles Hands-on experience in validating LIMS TrackWise SCADA CDS e g LabSolutions Chromeleon and PLC SCADA-based systems Proficient in authoring CSV documentation URS FRA IQ OQ PQ Traceability Matrix Validation Summary Reports Working knowledge of quality systems QMS tools and validation project management Familiarity with cGMP GDP and regulatory compliance Understanding of audit readiness and documentation standards Strong time management communication and coordination skills Qualifications Bachelor s or Master s degree in Life Sciences Computer Science Engineering or a related discipline Certification in CSV GAMP or related regulatory compliance preferred Key Responsibilities Experience 1-5 years of relevant experience in Computer System Validation within a regulated pharmaceutical biotech medical devices industry Experience validating both off-the-shelf and custom-developed applications in a GxP setting Key Competencies Attention to detail and strong documentation skills Analytical thinking and risk-based decision-making Effective communication and stakeholder collaboration Regulatory awareness and audit readiness Time management and ability to prioritize tasks under tight timelines Strong understanding of software system lifecycle and validation best practices Educational Qualifications Required Education Qualification B CA Required Experience 1 - 3 years

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