Syed Rahim Email Address

Associate Director, Quality Assurance Computerized Systems

Iron Wood Pharmaceuticals was added to CrunchBase in 2013

Experienced professional in the field of quality and validation within pharmaceutical and biotechnology domain. Established and managed a validation group to perform validation activities and improve on delivery timelines, execution reliability and quality of system through proper testing. Worked as Quality System validation and Supported regulated systems in the R&D space from solution selection, validation through operation and maintenance. Worked to improve on computer system validation methodologies and related processes like solution selection, change management, release management, incident management and project methodology approach.Made process improvements with inclination towards Software as a Service (SaaS) model due to the changing landscape and increased use of cloud solutions.  Involved in complex projects due to merger and demerger of companies. Audit experience as an Auditor for external supplier vendor companies and as an Auditee to defend the supported applications validation status in response to internal and external (FDA) audits. Training-Trained different groups to follow methodology approach developed in the company and provide guidelines on testing practices. Conducted training sessions as a lead trainer on CSV methodologies. Experience in developing part 11 assessment plans, CAPA strategies, Gap analysis and Remediation plans when needed. Exposure with different types of validation methodologies based on Agile, Waterfall and V-model. Involved in carrying out the Quality initiatives to perform Periodic Reviews, Inspection readiness, Annex 11 and maintaining application inventory. Demonstrated capability at building effective cross-functional and cross-cultural teams as well as establishing and maintaining positive relationships with both internal and external business partners. Maintained close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues. Worked on multiple projects at a time and worked on International projects with teams based in France and Germany. Well versed with regulations like 21 CFR Part 11, 58, 210, 211, 820 and GMP/GAMP/cGMP/GLP/GCP/SOX standards covered under FDA guidelines, ISPE, HIPAA and SEC guidelines. Also on EU Annex 11 regulations. Management of SOX ITGC controls and performed periodic testing to ensure compliance with SOX regulations. Supported internal and external SOX Audits and testing procedures.