Biological E - AM/DM - Quality Assurance - Projects

Job Description

Quality Assurance (Projects)

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 1100 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 : AM/DM- Quality Assurance (Projects)

Location : Hyderabad/Secunderabad

Academic Background and Experience:

- MSc Life Sciences with 5 + years of experience.

Purpose: To commission, qualify and validate green field projects

Job responsibilities

- Track of project charts and compliance of project timelines

- Prepare and review installation qualification, operational qualification and performance qualification

- Verify the technical and standard compliance in the commissioning activities following local and global guidelines

- Review the commissioning protocols and reports against specifications to meet project KPIs

- Review of commissioning IQ and OQ protocols for process equipment, environment, systems and utilities

- Commissioning, qualification and validation of greenfield projects

- Hands-on experience in process equipment and utilities

- Experience in temperature mapping activities

- Hands-on experience in computer system validation

Operating Network

Internal: Engineering, R& D, production and cross functional teams

External: Vendors

Technical Requirements: Insight on GMP concepts; knowledge in URS, DQ, IQ and drafting and documentation

Key personal competencies: Interpersonal skills, networking skills, communication skills, team management