Biological E - DGM - Development Quality Assurance

Job Description

Biological E Ltd is a leading global vaccine & pharmaceutical company which provides affordable immunization and medicines across the world. It has current turnover of around 1000 Cr and having employee strength of around 2000, growing at around 36% CAGR. Our intellectual pool of experienced scientist are based out of India and France. BE has state of the art manufacturing sites in India (Hyderabad and Dehradun).

Position title : Development Quality Assurance

Designation : Deputy General Manager

Location : Hyderabad/ Secunderabad

Academic Background and Experience:

- Post graduate in chemistry or pharmacy, with an experience of 12 - 18 years in Quality Assurance in the pharmaceutical industry

- Experience in developmental quality assurance

Purpose: to support development and clinical pipeline products.

Job responsibilities:

- Support implementation of appropriate quality systems for ANDA development activities.

- Support development of standard templates for transfer of scientific knowledge from lab to pilot scale; and further implementation across all R&D functions.

- Perform review of all documents pertaining to Development till Validation for Process & Analytical methods; on par with ICH guidelines

- Ensure development activities are performed in a manner compliant with USFDA and European regulatory expectations

- Perform internal audits of development work

- Perform quality audits of potential vendors for KSM and also of development + testing partners

- Ensuring that the quality of products, processes and systems are in compliance with regulatory requirements.

- Daily coordination with top management for various quality parameters and planning.

- Technology transfer activities optimization and development reports review.

- Handling of all QMS activities from product development to till product lifecycle management.

- Review of analytical method transfer, transfer study data and supporting launch of products in time.

- Review and approval of master documents likes SOPs, Specifications, Test methods, method transfer protocols and summary reports

Operating Network

Internal: R&D, QA, RA, and other functional experts

External: vendors, partners, experts

Technical Requirement: Strong understanding of pharmaceutical drug development process, preferably of complex Generics, knowledge of GMP and GLP regulations, ICH guidelines, FDA guidance documents.

Key personal competencies: Team Management, Good Communication Skills, Presentation skills, Problem solving and decision making, Critical Thinking.