This role will have a minimum of 5 to 8 years of experience in documentation management. Having the education qualification of post graduation in chemistry.
Documentation control and issuance:
Issuance and Retrieval of Documents to user departments (BMR, BCR, BPR, AR, ROAs, Logbooks, Forms and any other GMP documents).
Issuance of Specification, Method, Analytical report/ Record of Analysis (Intermediate, Finished product, Stability, Holding time study) to the relevant departments.
QMS:
Handling of Events, Change controls, CAPA, Customer complaints, Product Recall, OOS and any other QMS elements.
Timely completion of Assigned QMS elements on or before the due date.
Verification of CAPA Effectiveness wherever required.
Preparation and review of APQR:
Preparation, Review, and approval of Annual product Quality review documents and any other documents as applicable.
Internal Audit and Walk-through Inspections:
Perform Internal Audits as per schedule and ensure timely closure of the observation points.
Perform Walk through Audit as per the schedule and routinely monitor the area for GMP compliance.
Regulatory Inspections:
Provide the necessary documents for Regulatory and Internal inspectors.
To coordinate and carryout the inspection.
SOP preparation and Review:
Preparation and Review of Standard operating procedures.
Training:
Conducting relevant GxP training.
Conducting QMS related trainings (Change control, Deviation, OOS, CAPA and other QMS elements) for relevant functions.
Release:
Release of API to the market.
Compliancewire training management:
Compliancewire Functional area administrator (FAA).
Creation of user groups and related curriculum.
Addition of users, Uploading training material and quiz.
Managing and handling of assignments and follow-up of user reports.
Follow-up with users for timely completion of individual assignments etc.
Providing support to All Functional area administrators in the site.
Coordination for all cGMP training, and Quality system orientation training.
orientation training and other relevant trainings conducted at the site.
Tracking the number of cGMP trainings attended by every individual Employee.
Review, archival and Trackwise upload of Training completion Assessment forms.
Any other works as allotted by Business system Administrator (BSA).
Trackwise Digital:
Handling of Change control documents through Trackwise. Periodic review of open change controls and follow-up with user departments for closure.
Preparation of Trackwise reports for QMS trending (Change control, Events and CAPA).
Providing the required documents to RA for DMF filing.
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