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Head of Quality : Formulations / API

Job Description

Sound technical knowledge and background, especially pharma manufacturing & quality operations.

Should have handled US FDA approved large pharma operations at Site Quality Head level.

To continuously inspire learning and help acquire competencies (knowledge, attitudes, skills) of personnel in QC / QA matters and all across the organization 

To document and implement company’s overall validation policy, its intent and approach, including the validation of production processes, cleaning procedures, analytical methods, in-process control test procedures, connected computerized systems, and persons responsible for designing review, approval and documentation of each validation phase

To document and establish an effective system for managing quality that involves the active participation of management team encompassing the organizational structure, procedures, processes and resources, as well as activities necessary to ensure confidence to the customers and the management that the manufacturing activity shall always meet its intended specification for quality and purity.

To provide strategies from regulatory angle to help develop and build the business in the regulatory markets with speed and accuracy.  

To approve technology transfer documents and procedures prior to commercialization

To handle audits / technical queries from international regulatory authorities like US FDA, EDQM

Karthik B
Sr Consultant
Antal International Network
Tel: +91 80 65682908 
Suite 101. Floor 1, 5/2, Trump Tower, Eagle street, Langford town, Bangalore -560 025; INDIA