QMS Senior Executive

Aurobindo Pharma; Jadcherla; On-site; INR 600,000 - 900,000; Full time

Job summary

Aurobindo Pharma in Jadcherla, India, seeks a Production Operator/Supervisor to manage batch packing and ensure GMP-compliant manufacturing and storage.

The role involves coordinating with QA/QC, R&D, and engineering to execute production plans, maintain documentation, and train site staff on SOPs and URS. Strong focus on quality, safety and continuous improvement is required.

Qualifications

• Experience with GMP/QA/QC in pharma operations.
• Strong documentation and SOP experience.
• Ability to coordinate with multiple departments.
• Training and onboarding capabilities.

Responsibilities

• Perform batch packing activities on site.
• Ensure products are produced and stored per documentation for quality.
• Review production schedule and ensure its execution.
• Coordinate with QA/QC/HR/Engineering for SOPs and records.
• Train employees on applicable procedures.
• Prepare and review SOPs, URS and qualification docs.
• Act as PNC/Change initiator in QMS.

Skills

GMP/QA/QC

Documentation

Training

Cross-functional coordination

Tools

eResidue Pro

eLog

ERP

SharePoint

DMS

DSRS

Gemini Software

Sansoft SCADA

PMTS

EPIQ Learn IQ

Job description

• 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.