Apotex Pharmachem India Pvt Ltd Jobs in India

Serves as a Senior Executive role within Quality Assurance, and as a senior professional practitioner within the following areas of expertise: · Handling of Market Complaints · Handling of Supplier Qualification and Management · Nitrosamine assessment · Lead/Approve the deviation ...

Compilation and submission of new registration applications, deficiency responses, and pre-launch variations for assigned products. · Support in review and compilation of applications of drug products to International Health authorities of GCC, LATAM, APAC. · Support in review an ...

A role-holder to handle/supervise the Manufacturing activities and to ensure the on-time production and delivery of product with quality compliance and cost improvisation. · ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery ...

Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem Group of Companies' suppliers encompassing audit scheduling, execution, reporting, follow-up and closure of the audits. · Execute Corporate and supplier audits such as first GMP, routine, Targeted Tech ...

Under guidance of Supervisor or senior chemist, responsible for performing all activities in ARD-Test Centre including method validation for new products, full testing of API, in-process and finished dosages, and generates regulatory submission documentation. Acts as a key member ...

Compilation and submission of new registration applications, deficiency responses and pre-launch variations for assigned products, maintenance of documentation/database records pertaining to products, supporting and/or coordinating regulatory affairs projects, preparation of subm ...

Perform method verification/validation of compendia/pharmacopeial updations, Method verification of SDC's (Supplier Driven Changes) method. Method validation of cleaning verification, Preparation of method verification and validation protocols and reports, Evaluation of SDC, comp ...

Reporting to the Service Delivery Lead, GBS Global Quality, will hold responsibility to lead investigations (i.e. root cause analysis for identified non-conformances & associated CAPAs) and perform QA responsible tasks (i.e. detailed impact analysis, review, approval and implemen ...

Responsible for allocation of work to the technicians in shifts and ensuring completion of activity. Ensuring /Performing PM activities of Process equipment's within the specified limit and updation of work orders online. As per maintenance work request / corrective maintenance w ...

Regular review of materials inventory for expiring material, and determine re-tests. Responsible for the effective and timely execution of the material planning & production, lab scheduling . Creation of Production and Lab Scheduling, MRP Controllers, Logistics personnel, and Pro ...

Responsible for leading Regulatory Affairs individuals accountable for management of life cycle changes including change assessments and submissions all the way to approvals of PLCM (Product Life Cycle Management) projects to support regulatory compliance and the continued supply ...

Receipt of Finished goods from packing production, storage in ASRS , Palletisation, Export Documentation and Dispatch of Finished goods to various Countries. Documentation of Commercial Exports and Sample shipments. · ...

Preparation, review and reporting of process and cleaning validation studies, APQRs & trending. Review of equipment/ support system qualifactions, calibrations and production support activities. · Validation studies. · Preparation of Annual quality product review & Cleaning verif ...

Manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging validation and perform the activities in compliance with the various regulatory guidelines and standar ...

Responsible for the product life-cycle management of Apotex products in identified markets. Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures. Preparation of submission and approval notifications for appli ...

Operation and Maintenance activities of utilities system, Installation, Modification, Repair, Planning and executing upcoming projects, online documentation and review of documentation as needed or requested by the organization. · Ensuring and supporting to ARPL cross functional ...

We are seeking a highly experienced Senior Manager, Finance & Accounts with a strong background in Financial and Accountig , plant operations, Annual Operating Plan (AOP), and Inventory Management. · Closing books of account on monthly bais and preparing book closure schedules. · ...

Execution of analytical method optimization /development, validation/ verification of analytical test methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management (MLCM) studies, Supplier Driven Changes( SDC) an ...

Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. · Ensure timely completion of analysis and data completion for the same. · Be responsible for all activities in the Quality Control Laboratory, including cGLP, doc ...

We are seeking a highly experienced Senior Manager, Finance & Accounts with a strong background in Financial and Accounting, plant operations, Annual Operating Plan (AOP), and Inventory Management. · Closing books of account on monthly basis and preparing book closure schedules. ...