Umed Singh Email & Phone Number

Ghaziabad, Up, In

Delhi, India

• Controlling access to archives.• Ensuring that orderly storage and retrieval of materials is facilitated (e.g. using indexing).• Ensuring that movement of material in and out of the archives is properly controlled and documented.• Ensuring that material submitted for archiving corresponds to that described in the chain of custody documentation.• Implements records indexing and delivery solutions for permanent and inactive records.• Maintenance of archives includes monitoring archives’ environmental conditions (like temperature and relative humidity), pest control, etc.• Timely intimation to the management regarding the expiry or the retention period of the study Preparation of SOPs related to archives.• SOP Management, which includes SOP distribution and retrieval.• Destruction of copies of obsolete versions of SOPs.• Maintaining electronic copies of SOPs.• Issuance of raw data forms, work instructions, and logbooks.• Cross-check the data with the source record and resolves the query.

Ghaziabad, Uttar Pradesh, India

• Receipt, labelling, handling, storage and maintenance of accountability of Test and Reference Item. • Issuance of Test and Reference Item to study personnel based on their request.• Monitoring and maintenance of storage conditions of Test and Reference Items in the TICU.• Management and operation of various instruments/equipment’s in TICU; which includes calibration, • maintenance and troubleshooting/resolution of any instrument problem. • Preparation, review and revision of Standard Operating Procedures related to TICU• Preparation and maintenance of all the documents related to the TICU• Coordinate with Study Directors, Quality Assurance Unit, Engineering Services Department and Project Management Cell• Archival of Test and Reference Item• Disposal or Return of Test and Reference Item to Sponsor based on request.• Ensure/follow correct waste disposal procedure (segregation) in TICU• Allotment of SOP Number.• Distribution of copies of effective SOPs, retrieval and disposal of copies of withdrawn SOPs.• Preparation/updating Master List of SOPs.• Archival of Master copies of withdrawn/superseded SOPs.• Updating of Master Schedule and distribution of copies of Master Schedule.• Allotment of Study Number.• Issuance of DRS, logbooks, WIs and Manuals.• Taking specimen signature and maintaining signature log.• Coordinating for binding of Logbooks and Laboratory notebooks

Gurgaon

• Ensured the security and compliance of all documents related to active and archived projects. Ensured that all project documents are maintained in accordance with relevant Standard Operating Procedures (SOPs)/ Work Instructions (WIs)• Ensured timely filing of all project documents submitted to eTMF and kept the eTMF ready for any audit and review.• Responded promptly to each request received for a project document or project file form, Project management or internal team to ensure timely solution of the given task.• Assisted team for maintenance of the quality of department output functions.• Participated in project specific training as required.• Performed eTMF reviews during ongoing studies or at the end, in order to prepare the eTMF for return to sponsor.• Prioritized work for all tasks required for Trial Master File Room and as per forms supported the tasks related to creation and maintenance of the document / file repository and archival for all site related electronic documents.

Gurgaon, India

• Ensured the security and compliance of all documents related to active and archived projects. • Ensured that all project documents were maintained in accordance with relevant Standard Operating Procedures (SOPs)/ Work Instructions (WIs)• Ensured timely filing of all project documents submitted to eTMF and kept the eTMF ready for any audit and review• Responded promptly to each request received for a project document or project file form, Project management or internal team to ensure timely solution of the given task.• Assisted team for maintaining the quality of department output functions.• Participated in project specific training as required.• Performed eTMF reviews during ongoing studies or at the end, in order to prepare the eTMF for return to sponsor.

Ghaziabad District, Uttar Pradesh

Document Controller / Archivist (Controlling access to archives)• Preparation of eCTD module- 5 (CSR, FDA Table, Bio Table, EU Table, CRF, Module5-2, Module 2-7, Module 5-4).• Ensured that orderly storage and retrieval of materials is facilitated.• Ensured that movement of material in and out of the archives was properly controlled and documented.• Ensured that material submitted for archiving corresponds to that described in chain of custody documentation.• Implemented records indexing and delivery solutions for permanent and in active records.• Performed maintenance of Archives which included monitoring of archives environmental conditions (like temperature and relative humidity), pest control etc.• Timely intimation to the management regarding the expiry of the retention period of the study.• Preparation of SOPs related to archives.• SOP Management, which included SOP distribution and retrieval• Destruction of copies of obsolete versions of SOPs.• Maintained electronic copies of SOPs• Issuance of raw data forms, working instructions and logbooks.• Assisted QA team in different functions whenever needed.• Receipted and issued test item and reference item when applicable.• Monitored daily clean in go TICU (Test Item Control Unit).• Monitored environmental conditions (temperature and RH etc.) of TICU (Test Item Control Unit).

Noida Area, India

QA Assistant• Responsible for understanding regulatory guidelines related to Good Document Practice, Good Clinical Practice and Good Laboratory Practice, Standard Operating Procedures and work flow elements relevant for this role.• Distributed new / revised Standard Operating Procedures to respective departments / locations and withdrew retired Standard Operating Procedure when applicable.• Collection and review of staff qualification records (CVs, JDs, training records / matrices) and the process for filing and retrieval• Maintained training records of employees and tracked training records of Clinsys Noida and Clinsys Bangalore.• Issuance of forms and logbooks to different departments as per applicable SOPs• Assisted archivist in day to day functions like archival and retrieval of data, maintenance of archives etc.• Responsible for collation (e.g. Auditplan, audit reports etc.) and filing of QA Documents.• Updated office manual as per requirements.