Tiya Saraswati

Experience

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  PT Sanbe Farma

  Oct 2015 - Mar 2019

  Regulatory Affair and QA Pharmacist

  1. Prepared and reviewed regulatory documents required for product registration to Indonesia Food and Drug Administration (BPOM) and for export, ensuring coordination with relevant departments to meet submission timelines. 2. Participated in regulatory meetings with BPOM to address regulatory queries and provided required responses and additional documentation in a timely manner.3. Prepared document for internal and external audit including inspection by Ethiopia (2016), WHO (2017), Uganda (2017), BPOM (2018); followed up on CAPA until closure within defined timelines.4. Conducted routine inspections across departments to ensure compliance with the cGMP and regulatory standards.5. Performed investigation across departments to find root cause deviation in deviation product and ensured appropriate resolution before product release.6. Delivered GMP training program to all employees across departments to promote quality culture and regulatory awareness.7. Reviewed batch records and acted as QA Manager proxy in authorizing the release of finished product (normal batch) for market distribution.8. Reported changes related to raw materials, testing methods, packaging, and other product-related aspects to the Regulatory Authority (BPOM), in accordance with regulatory obligations. 9. Reviewed product packaging design to ensure compliance with national and international regulatory requirements. 10. Provided regular updates on document readiness and submission progress to the Registration Department at Head Office. Show less

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  Equilab International

  Dec 2019 - Feb 2022

  Clinical Research Associate & Regulatory Affair

  1. Led newly joined CRAs and coordinated multi-site clinical trial activities for global COVID-19 vaccine study. Trained and mentored newly joined CRAs, supporting their onboarding process.2. Oversaw end-to-end clinical trial activities as defined by ICH-GCP guidelines including site readiness, subject recruitment, and protocol compliance3. Performed routine monitoring visits (on-site and remote) to verify source data, ensure CRF completeness, data quality, and patient safety. 4. Issued and resolved data queries and developed detailed monitoring visit reports.5. Oversaw investigational product (IP) management activities, ensuring proper storage, dispensing, and accountability in accordance with protocol and GCP.6. Prepared the essential documents, ensured quality and completeness of essential trial documents at site level and sponsor to support inspection-readiness and trial integrity 7. Prepared and submitted regulatory dossiers to BPOM to obtain approval for the clinical trial initiation and to local and central EC/IRB to obtain Ethical Clearance Approval.8. Responded to regulatory and ethics queries by directly communicating with BPOM and ECs and providing timely submission of additional documentation.9. Reviewed adverse events (AEs) and serious adverse events (SAEs) for protocol compliance and ensured timely reporting by investigators to sponsors, ECs, and BPOM.10. Coordinated and prepared for site close-out visits.11. Acted as the primary liaison between sponsor and investigator, facilitating clear communication and timely resolution of site-level issues.12. Provided regular updates on study progress to sponsor and cross-functional teams, supporting strategic decision-making.13. Contributed to multi-center trials involving Covid-19 Vaccines, Vaccine Adjuvant, Supplement for Covid-19, Stem cell for Covid-19, Sport Soft Tissue Injury Treatment, Chronic Kidney Disease, Diabetes Polypills, and dermatological Patch Testing. Show less

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  INA RESPOND

  Jun 2022 - Aug 2025

  Clinical Research Associate

  1. Act as Monitor in observational studies, including COVID-19 Study and HIV Cohort Study.2. Perform routine monitoring visits (on-site and remote) to verify source data, ensure CRF completeness, data quality, patient safety and specimen management.3. Monitored 9 sites (2,074 subjects) for HIV study across 8 cities in Indonesia and 2 sites (472 subjects) for Covid-19 Study across 2 cities in Indonesia. 4. Ensure quality and completeness of essential trial documents at site level and maintain audit/inspection readiness.5. Issue and guide site team to resolve data queries and develop detailed monitoring visit reports.6. Identify and record protocol deviations and follow up with site staff to ensure appropriate CAPA were implemented in accordance with GCP and sponsor requirements.7. Review adverse events (AEs) and serious adverse events (SAEs) for protocol compliance and ensure timely reporting by investigators to sponsors, ECs, and BPOM.8. Coordinate and prepare for site close-out visits.9. Conduct QA of Study Specimen Inventory in Reference Laboratory. Show less