Job Title

Software Quality Assurance Manager

Company Name
Concerto HealthAI Solutions
Job Type
Full-time
Qualification
Bachelor’s Degree
Experience
5 Years  -  7 Years
Vacancies
1
Salary Offered
Not Disclosed
Job Category
Location
Bangalore, Karnataka, India
Job Description

Role Summary:
The Software Quality Assurance Manager is responsible for oversight of the team supporting quality control throughout the development of multiple software organizational data products and clinical development technologies. The Manager is responsible for scoping and delegating the work associated with validation documentation, UAT, developing and executing on a testing strategy, performing validation activities, and authoring validation deliverables. The incumbent will be responsible for designing and conducting software tests and continuing to develop and mature the company’s validation practices. The Senior Software Quality Assurance Manager must be able to manage competing priorities, simultaneous multiple validation activities while and ensuring the highest quality testing and validation practices and deliverables. The individual will manage an expanding team of software QA specialists and is responsible for providing all required support of completed validation documentations in internal and external audits and/or inspections. This role is for an experienced SQA professional and will act as a leader with responsibilities for ensuring quality and mentorship of junior SQA staff.

Responsibilities
Lead a growing team of software QA specialists by scoping and assessing the needs of multiple data products, planning and delegating the work for completion to required timelines.
Provide software QA SME in all required audits and inspections, ensuring organizational compliance and successful audit completion.
Determine timelines and lead project management activities associated to developing standard and release-specific test scripts, validation of requirements and completion of testing and validation deliverables with minimal supervision.
Provide supervision and mentorship to junior SQA staff
Act as responsible SME to provide expertise on experience with validation / compliance practices and have worked with multiple types of software, and testing vendors.
Responsible for deliverables, leading and oversight of all 21 CFR and GxP validation packages for product/development teams across the organization, review and approve all the validation artifacts.
Responsible for deliverables, leading and oversight, development + approval of the test packages and facilitate UAT (User acceptance testing) with client teams.
Responsible for solutioning and resolving issues with software validation activities and conveying escalations to leadership or other department members in a timely manner, requiring excellent written and verbal communication skills
Primary POC and SME during internal and external audits.
Develop creative solutions for complex software and business issues and apply these solutions to resolve problems
Manage multiple projects and competing priorities under strict timelines.

Requirements
Bachelors degree required
Minimum 5-7 years’ experience performing software validation on major system releases
Advanced knowledge of 21 CFR Part 11 compliance is required
Compliance, and additional validation guidelines are mandatory for success in this role
Must be organized, detail-oriented, and able to coordinate multiple projects with shifting priorities
Must be able to work independently and as a part of a team
Demonstrates the tenacity to learn and adapt quickly
Has a strong work ethic and is comfortable under the pressure of tight deadlines
Strong proficiency in the entire Microsoft Office Suite

Key Skills

Recruiter's Name
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Telephone
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Posted Date
May 27, 2023
Additional information

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