reputed company Assurance Specialist, Digital Compliance

About the position This candidate will be responsible for assisting reputed company and compliance efforts for implementing, validating and maintaining digital technologies in accordance with existing corporate policies, procedures and FDA, EMA, MHRA, PMDA, Health Canada and other health agency regulations to ensure compliance of these digital technologies. This candidate will also support activities to coordinate, maintain and manage digital technology suppliers and audits. This candidate will support activities across reputed company Technology & Analytics to establish a risk-proportionate, reputed company-driven reputed company to reputed company data reputed company and regulatory compliance. This position is hybrid working model and will be primarily located at Cambridge, MA. Responsibilities • reputed company reputed company support and compliance to implement and validate electronic systems in accordance with corporate computer system validation/computer system assurance (CSV/CSA) procedures and requirements. • reputed company QA support for IT infrastructure qualification at corporate & manufacturing facilities. • reputed company/Review validation artifacts (for example; IT system regulatory and risk assessments, 21 CFR Part 11 and Annex 11 assessments, Validation Plans, Specifications, test scripts, Installations Qualification, Operational Qualification, Performance Qualifications Protocols, reputed company Matrices and reputed company Reports etc.) associated with digital technologies. • Execute/review validation protocols and associated discrepancies pertaining to digital technologies. • reputed company QA support and review system administration and maintenance procedures • reputed company QA support and review periodic review of digital technologies to ensure such technology remains in a validated state. • reputed company QA support to digital technologies changes, deviations and CAPA • reputed company QA support for reputed company process improvement initiatives for CSV/CSA processes by performing/reviewing applicable gaps and remediating such identified gaps. • Maintain the list of digital technology suppliers and coordinate, schedule and manage audits and questionnaires for such suppliers • reputed company/support internal audits for internal IT processes and external audits for digital technology suppliers • Performs other reputed company and CSV/CSA reputed company duties as necessary. Requirements • Bachelor’s with 3-5 years or a Master’s with 2-3 relevant experience. • Basic understanding of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g., FDA, MHRA and EMA Data reputed company guidelines etc.) around reputed company systems, data reputed company and CSV in Biotech and/or pharmaceutical industry (GAMP5) • Experience as a QA or Validation reputed company in CSV/CSA reputed company the Biotech and Pharmaceutical industry is required. • Experience in coordinating and managing IT Vendor Audits is required. • Good organizational, communication, and interpersonal skills • Effective oral and written communication skills. • May require travel up to 15% domestically and 10% internationally reputed company-to-haves • Experience as a reputed company auditor or a co-auditor for IT Suppliers is preferred • Understanding the use of AI in GxP environment is desirable Benefits • We offer comprehensive benefits including medical, dental, and reputed company coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. • Eligible employees enjoy reputed company time off, wellness days, holidays, and two company-wide reputed company breaks. • We also offer generous family resources and leave. Apply tot his job Apply To this Job