QMS Senior Executive

Responsible to perform the Batch Packing Activities at site .
To ensure that the products are produced and stored according to the appropriate documentation in order to obtain the required quality.
To review production schedule based on production plan and ensure its implementation.
Interface with R&D / technology transfer departments for execution of scale up and exhibit batches in plant.
Responsible For ERM & SUR Business User In M7
On line documentation, in process checks and Review of ANDA submission documents related to production.
Initial and continuing training of all employees in department are carried out according to need.
To prepare and review the relevant Standard Operating procedure (SOP), User requirement specification (URS) and qualification documents.
Ensure the timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
To involve in investigation team, market complaint & find out the probable root cause and establish the preventive actions to avoid re-occurrence of the event.
Close coordination with supporting department (QA/QC/HR/Admin/Engineering/ Validation) for preparation of SOPs, Batch Record, Qualification and Equipment procurement documents.
Responsible to act as PNC Initiator, Change initiator, Change Action owner, Exception Initiator , MNC Initiator in Quality Management System(QMS).
To perform the activities in eResidue Pro Software as a Production Verifier”.
To perform the activities in eLog software as “ELOG Reviewer”
To perform the activities in ERP Software as per assigned roles.
To perform the training related activities in Training Management system - EPIQ Learn IQ Software.
To act as a Trainer and impart training to all employees at site for the applicable procedures.
Responsible to perform the activities as User in SharePoint.
To act as DMS User in Document Management System (DMS).
To act as “User ” in Document Storage and Retrieval System (DSRS).
To act as “Production Operator” in Gemini Software.
To act as “System Viewer” in Sansoft SCADA Software.
To act as “Production Supervisor” in Pharma Material Tracking System (PMTS).
To perform OPEX material procurement in ERP as Requistioner.
To act as an ERM Business User & SUR Business User in ERM.
To perform the activities in the GxP applications with respect to the assigned roles and responsibilities.
Responsible to follow the laid down Quality Culture principles and behaviours at site.
To monitor and control CAPEX, OPEX, material usage, operating expenses in order to control product cost & remain within agreed norms.
Responsible for periodic calibration of instruments and breakdown equipment’s rectification, by coordinating with engineering team.
All the time audit readiness and address issues raised during these audits.
Responsible for internal GMP audits, shop floor compliance.
To set goals and take corrective action for productivity improvement and cost reduction.
Responsible to participate in Quality Risk Management exercises.
To carry out any other responsibility / additional work assigned by Department head as per organizational requirement.
To ensure the safety, health and environmental policy requirement in the plant and carrying out environmental management system related activities.
Responsible for adherence to quality compliance.
During absence, Authorized Deputy persons shall perform the above responsibilities according to the requirement.