上海招聘

SCOPE OF THE ROLE AND BASIC PURPOSE:

Position Description

Supports Site R&D Q&C Lead in ensuring quality and compliance to internal and external requirements during product development

 

Scope of the Role and Basic Purpose

• Supports R&D Q&C Manager in maintaining Quality System execution within the R&D environment.

• Implement quality systems and controls that are appropriate, effective and efficient during product development to ensure that R&D is operating with sound scientific practice and in compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), regulations and Quality Policy Standards

• Coordinates site inspection readiness activities

• Participates in nonconformances, out of specification and out of trend investigations to ensure that the root cause is appropriately identified, and robust CA/PA taken. Reviews and approves investigation and CAPA reports to ensure that documentation is complete and consistent to meet the GDP requirements.

• Reviews and approves GxP documents such as change controls, standard operating procedures, stability protocols and reports, test method validation/transfer protocols and reports, instrument qualification protocols and reports.  Assists R&D in preparing clear and understandable procedures

• Supports R&D Q&C Lead on supplier management (supplier audits/monitoring and preparation of quality agreements)

• Provides quality and compliance oversight of contract laboratories through periodic reviews of the contract laboratories' quality system (deviations, CAPA, change controls, investigations)

• Conducts periodic reviews of computerized system validation

• Consolidates/analyzes quality metrics for Quality Data Review and proposes continuous improvements based on the analysis

• Key R&D Q&C contact for design controls

   

 

EDUCATION, EXPERIENCE, KNOWLEDGE and ABILITY REQUIREMENTS

 

• At minimum, Bachelors degree of Science-related or Engineering course; Master’s degree is desirable

• 6-8 years experience in a regulated industry.  Experience in analytical or microbiology laboratory is desirable

• With good knowledge of GMP and GLP regulations in Pharmaceutical and/or Medical Device and/or Cosmetics

• Experience or understanding of product development process

• Analytical thinker and possesses strong problem-solving skills

• Can easily learn computerized systems

• With strong communication and interpersonal skills

• Ability to independently plan, organize, coordinate, manage and execute tasks

• Demonstrate ability to challenge status quo

强生（中国）投资有限公司 强生中国有限公司诚聘