Author and Document Reviewer

Syngene

6 - 9 years

8 - 11 Lacs

bengaluru

Posted:2 weeks ago| Platform:

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Skills Required

ehs grn lms test scripts edms packaging manager quality control gmp outsourcing operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Reviewing LIMS/ELN relevant documentation, SOP s, training presentations, and any other documents related to CSV requirement for any enhancements or new implementation/Modules. Collaborating with IT and QA to facilitate validation activities, writing/execution/review of Test Scripts, and effective implementation of LIMS. Ensuring the proper functioning of LIMS application as per the business needs through rigorous testing.
Review of Specification, Standard Operating Procedure, Instrument Operating Procedures, General procedures. Observation data sheet, calibration data sheets, protocols and reports etc.
Creation/ preparation of documents, master data/ static data creation in LIMS, ELN and LMS Softwares as applicable.
Review of documents and records related to routine operations in quality control. Review of documents in EDMS and TrackWise.
Involving in Investigation and closure of OOS, OOT, Laboratory incidences, deviation and Non-Conformity as applicable.
Check consignment documents like COA, MSDS, GRN, TRF, FTRF etc and monitor sampling of Raw materials, packing materials, In-process, Validation, Finished products, water sampling and miscellaneous materials as applicable and certify the accuracy, adequacy and timeliness of the activity performed by analysts.
Responsible for imparting training to New joiners, Consultants, Deputation Transfer etc.
Record updation for Outsourcing of sample testing based on requirement and updating respective Logbooks.
Preparation of Standard Qualification protocol, Report and COA as applicable.
Archive and retrieve documents related to the section.
Act as training coordinator for QC. Assignment of procedural training and recording training in LMS coordinating for internal and External trainings etc.
Adherence to Good Laboratory Practice and Good documentation practices.
Cleaning of workplace and following Good Laboratories Practices while working in QC Laboratory.
Individuals working in the GMP environment are responsible for documenting/record the activities contemporaneously and accurately as per Good documentation practices.
Responsible for taking any other job allocated by Head QC / Group Leader /Section Head

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