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Computer Systems Validation and Compliance Director

Secunderabad, Telangana
Job Code:
  • Manufacturing & Production
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Job Details

ResponsibilitiesCreate and oversee a validation/compliance group to provide consulting services to Aztec clients.Build validation and compliance group by hiring appropriate resourcesTrain resources to provide optimum level of compliance and validation services to Aztec clientsManage and motivate validation and compliance group membersConduct periodic audits of internal Aztec policies and procedures to ensure that projects are following internal compliance and validation proceduresCreate and oversee data integrity policies for manufacturing, laboratory and enterprise systems to comply with regulatory guidance s and requirements (e.g., 21 CFR Part 11).Create, review and/or approve Good Manufacturing Practice (GMP) documentation such as Standard Operating Procedures (SOPs), validation plans, user requirements specifications (URS), functional and design specifications (FS and DS), testing protocols (IQ/OQ/PQ), user acceptance testing, traceability matrices, validation reports, and change control documentation to support all validation activities per the validation master plan.Perform and/or oversee all aspects of CSV including planning and developing validation strategies in conjunction with the customer and system owner(s), creating all required GMP documentation, and the actual validation(s) in conjunction with system owner(s) per the validation master plan.Provide guidance and support to customer Quality Assurance (QA) and IT departments, and the system owner(s) with focus on both new and on-going validation and compliance initiatives.Stay up-to-date with industry best practices, industry benchmarks and FDAs views in regards to CSV.Participate in internal and external audits, including Food and Drug Administration (FDA) Audits.Assist with estimates of man-hours required to complete projects.Manage execution of compliance and validation projectsMonitor progress of projects.QualificationsA Bachelors degree in Engineering or Science.A minimum of eight (8) years experience in the Life Science industry.8+ years minimum experience in either an IT or Quality role performing and developing CSV processes and procedures.3+ years of experience managing a compliance/validation groupExtensive knowledge of CSV, GAMP 5, Data Integrity and 21 CFR Part 11Practical application of CSV Industry Standard Best PracticesHardware & SoftwareExperience validating and enforcing compliance with following types of systems is required Process Control SystemsBuilding Management SystemsLaboratory SystemsData HistoriansDatabases and Data WarehousesLIMSMESERP SystemsOther enterprise systems such as CMMS, etc
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 8-13


IT | Operations/Customer Care | Production
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