About the job

The Senior Software Quality Engineer is required to ensure that compliance to the site, corporate and regulatory body equipment & automated system and software validation requirements.Note: This is NOT a Testing role.

Key Responsibilities:

Subject Matter Expert on equipment & automated systems validation.
Strong working knowledge on Software Validation
Responsible for the review and approval of all documentation through the equipment and automated systems lifecycle.
Ensure regulatory compliance with internal and external validation regulations, particularly with corporate non-device software requirements.
Ensure relevant procedures are kept up to date and maintained to the relevant standards and to industry best practice.
Provide guidance and assistance with the preparation of validation protocols, test protocols, software design specifications, and associated documentation for all applications supporting the quality system and equipment and automated systems.
Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for System designs.
Provides guidance, training and direction the non device software lifecycles to staff across various functions.
Provide software validation/compliance/part 11 leadership.
Take part in vendor audits of critical equipment vendors.
Present relevant documentation during internal and external audits.

Responsibilities

About the job

Key Responsibilities:

Subject Matter Expert on equipment & automated systems validation.
Strong working knowledge on Software Validation
Responsible for the review and approval of all documentation through the equipment and automated systems lifecycle.
Ensure regulatory compliance with internal and external validation regulations, particularly with corporate non-device software requirements.
Ensure relevant procedures are kept up to date and maintained to the relevant standards and to industry best practice.
Provide guidance and assistance with the preparation of validation protocols, test protocols, software design specifications, and associated documentation for all applications supporting the quality system and equipment and automated systems.
Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for System designs.
Provides guidance, training and direction the non device software lifecycles to staff across various functions.
Provide software validation/compliance/part 11 leadership.
Take part in vendor audits of critical equipment vendors.
Present relevant documentation during internal and external audits.