Syngene International Ltd
Designation : Associate Scientist
Function : Discovery Services
Functional Area : GLP Documentation
Job Role Summary : GLP Document Control, Study Protocols Issuance and Reconciliation, Clinical sample management
Job Profile :
- Responsibilities as Document Controller in GLP System.
- Ensure compliance with the requirements of GLP, ISO/IEC 17025, OECD or other required regulatory guidelines.
- Responsible for the management of documents.
- Distribution of MOAs and Formats.
- Issuance of MOA numbers, Logbooks number, Validation document number and Spreadsheet numbers etc., related to GLP functions.
- Issuance and reconciliation of Study related recording formats and facility related recording formats, SOPs as applicable.
- Issuance of validated Microsoft Excel spreadsheets
- Maintain a list of Specimen Signatures, List of GLP Personnel in consultation with HODs.
- Preparation and update log of MOA index, log of logbook index.
- Uploading Study related, facility documents and general recording formats, as applicable in Syngconnect.
- Updating of SAP and ERP.
- Archiving master copies of MOAs.
- Archiving facility related documents.
- Assigning training on LMS for employees to ensure compliance.
- Preparation of SOP’s / Formats, as applicable.
- Engage in vendor evaluations to ensure alignment with quality, regulatory and technical standards
- Ensure optimal performance of laboratory equipment by establishing and adhering to GLP standards, quality control procedures, and troubleshooting protocols. Oversee instrument qualification, certification, and compliance, and manage equipment servicing, repair, and replacement
- Responsible in supporting clinical sample management including shipment tracking, ensuring compliance with study protocols. Maintain accurate inventory and support cross-functional team for timely sample handling, Communicating with sponsors, SDs and Sample custodian for uninterrupted execution
Job Requirements :
- Looking for an entry level lateral from science background.
Type of Experience : Lateral Entry for Candidates with Science background
Academic Qualifications :
- Ph.D., in Biotechnology with thorough knowledge in vector design, protein expression and cell line engineering.
