Regulatory Executive

Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives :Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department.1. Dossier Preparation and ReviewOversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with...

Full Time - August 4, 2021 **Location**: **Pithampur**: **Salary**: **up to 4.2 Lacs**: **Experience**: **Minimum 5 Year**:

Job Description Join Lupin Limited's dynamic IT Operations team as an Executive dedicated to ensuring the highest standards of compliance and system integrity across our computerized software systems. In this role, you will take a proactive stance in validating computer system software and sustaining its validated status in strict accordance with Standard...

Role Overview:The Lab QA/QC Reviewer will be responsible for the comprehensive review and approval of analytical data generated by the QC laboratory.This role ensures data integrity, compliance with regulatory guidelines, and facilitates resolution of quality investigations related to lab incidents.Key Responsibilities:Perform detailed analytical data review...

Process Validation:Plan and execute process validation activities for sterile injectable products as per cGMP and regulatory expectations.Prepare and review validation protocols and reports, ensuring compliance with internal SOPs and global regulatory guidelines (e.g., USFDA, EU-GMP, WHO).Cleaning Validation:Develop and implement cleaning validation...

Role & responsibilities :Review of all QMS documents related to regulatory submissionsPrepare status of all documents related to submissionCo-ordinate with all stakeholders of plant for collection of documentsProvide all regulatory documents to HO-RA for submission.Evaluation of change control, deviations and out of specifications.Review of specifications,...

Job Title:Executive – QA / MISDepartment: Quality AssuranceLocation: pithampurAbout the Role:We are seeking a detail-oriented and proactive Executive – QA/MIS to join our Quality Assurance team. The ideal candidate will be responsible for monitoring and improving quality control processes, maintaining data accuracy within MIS systems, and ensuring...

Roles and ResponsibilitiesReview and approval of Master Documents such as Batch manufacturing record /Batch packaging record, Specification, Standard test procedure, Standard operating procedure, Qualification/ Validation protocols and reports.Preparation and review of Site Master File.Review and approval of Quality System document such as Deviation, Change...

Purpose of Job:To operate and maintain all Boilers as per regulatory/Statutory requirement.To carry out operation & maintenance activities in Boiler, HVAC, Water System, and other Utilities.To execute preventive and breakdown maintenance of boiler and utility.To maintain good housekeeping and GEP.To follow rules and regulation implemented time to...

The purpose of this role is to :-.The Group leader of Formulation and Development (Injectables) will oversee the design, development, and optimization of sterile injectable formulations. This role will lead a team of scientists and collaborate closely with cross-functional teams, including Analytical, Regulatory, Quality, and Manufacturing, to ensure...