Quality Systems

Job Opening for Quality Systems - Software QA, Hopkinton MA

We are currently working on below mentioned job opening i.,e. Job Opening for Quality Systems - Software QA, Hopkinton MA. Please let me know if you are interested in applying for the same.

Requirements : Quality Systems - Software QA is responsible for supporting QA review of software development lifecycle documentation with a specific focus on validation/implementation of new software systems.

Responsibilities Include:

• Review/Approve Test Scripts
• Review Validation Summary Reports, Installation Qualification, Operational Qualification, Performance Qualification, and Trace Matrices, escalate issue to management
• Support the development of training content
Direct reports

This position will not have direct reports

• 5+ years relevant Quality Assurance experience in a pharma/biotech company, working within a regulated GMP environment.
• Prior experience with implementing software systems and/or continuous improvement initiatives focused on software systems
• Ability to partner cross functionally and integrate feedback during development and implementation of quality systems
• Ability to work independently to meet objectives and timelines
• Has an awareness of cGMP and ICH regulations/ guidelines and GAMP-5
• Prior experience with electronic test systems preferred (e.g. Valgenesis, Kneat)

This is a full-time position (Monday through Friday) with some opportunity for remote work. Prefer 80% onsite (so 4 days per week, most likely)

Job Opening for Quality Systems - Software QA, Hopkinton MA

We are currently working on below mentioned job opening i.,e. Job Opening for Quality Systems - Software QA, Hopkinton MA. Please let me know if you are interested in applying for the same.

Requirements : Quality Systems - Software QA is responsible for supporting QA review of software development lifecycle documentation with a specific focus on validation/implementation of new software systems.

Responsibilities Include:

• Review/Approve Test Scripts
• Review Validation Summary Reports, Installation Qualification, Operational Qualification, Performance Qualification, and Trace Matrices, escalate issue to management
• Support the development of training content
Direct reports

This position will not have direct reports

• 5+ years relevant Quality Assurance experience in a pharma/biotech company, working within a regulated GMP environment.
• Prior experience with implementing software systems and/or continuous improvement initiatives focused on software systems
• Ability to partner cross functionally and integrate feedback during development and implementation of quality systems
• Ability to work independently to meet objectives and timelines
• Has an awareness of cGMP and ICH regulations/ guidelines and GAMP-5
• Prior experience with electronic test systems preferred (e.g. Valgenesis, Kneat)

This is a full-time position (Monday through Friday) with some opportunity for remote work. Prefer 80% onsite (so 4 days per week, most likely)