Senior Quality Assurance Specialist

3 weeks ago

India MMS Holdings Full time

Are you looking to join a company where your contributions truly matter and where you ll be part of a supportive innovative team MMS is a award-winning data-focused clinical research organization CRO We pride ourselves on being a Great Place to Work certified organization recognized for our exceptional culture and industry best employee retention rate We support the pharmaceutical biotech and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges With a global footprint across four continents MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive Join us at MMS and be part of a team that is shaping the future of clinical research Discover more about our exciting opportunities and why MMS is a great place to advance your career Visit or follow MMS on Lead and support Computer System Validation CSV activities across clinical systems e g EDC CTMS LIMS Acts as SME Create review and manage validation documents such as Validation Plans Test Scripts Traceability Matrix and Reports Ensure compliance with GxP 21 CFR Part 11 and other regulatory guidelines related to system use in clinical environments Collaborate with IT QA and Functional Leads to ensure quality and regulatory expectations are met during system implementation or change Participate in internal and external audits and provide documentation support during regulatory inspections Contribute to SOP development risk assessments and periodic reviews Maintains a strong understanding of regulations and guidance as they pertain to compliance mentors others advises on MMS updates related to regulatory updates Proficient in authoring QMS related documents i e SOPs Work Practices Forms Training Materials etc independently mentors others acts as SME Develop CAPA plans and contribute to resolution of audit findings independently mentors others acts as SME Monitor vendors to ensure CSV processes are followed and quality is maintained independently mentors others acts as SME Assists in internal process and document QA audits per procedure independently and in collaboration mentors others acts as SME Ability to support document development SOPs WPs Support timely maintenance of multiple QMS trackers creation updates to Ops meetings applicable PowerPoint Job Requirements Graduate degree in scientific medical clinical discipline or related field or related experience Masters preferred 7-10 years of experience in Computer System Validation CSV Prior experience in the clinical research or pharmaceutical domain is a must Hands-on knowledge of GAMP 5 GxP 21 CFR Part 11 and other applicable regulations Excellent documentation and communication skills Detail-oriented process-driven and proactive in identifying risks or gaps Understanding of CROs and scientific and clinical data terminology Excellent ability to multitask attention to detail and organizational skills Exposure to Regulatory Technology RegTech systems or electronic document management systems EDMS is preferred

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