Larsen & Toubro Infotech Ltd MSc Life Sciences Specialist Quality Engineering

The Contractor – Sr. Quality Specialist – IT Quality Assurance, Regulatory Affairs and Compliance (QARAC) are responsible for performing an independent quality review and approval of computer system validation/qualification deliverables in alignment with internal procedures and government regulations. The candidate will support computer system validation projects and the validation lifecycle of existing and new computerized systems used for pharmaceutical and biotech processes.How will you make an impact?

You will contribute as a member of the IT Corporate Solutions and Integrations – IT Quality Assurance, Regulatory and Compliance (CSI-QARAC) Team reviewing and approving computer system validation deliverables.

What will you do?

• Review and approve risk-based deliverables related to computer system validation in alignment with the GxP regulations such as 21 CFR Part 11, Annex 11, GAMP 5, and other regulatory requirements.
• Review and approve validation documentation – such as user requirements, functional requirements, risk assessments, configuration specification, Validation Plan (VP), IQ/OQ/PQ documentation, GxP criticality assessments, Electronic Records Electronic Signature (ERES) assessments, Data Integrity (DI) assessments, test scripts, trace matrix, testing defects, validation summary reports, and system use documentation (system admin, user admin procedures).
• Assist with the authoring and development of SOPs for computer system validation and quality assurance.
• Perform gap analysis against internal policies, procedures and industry regulations.

How will you get there?

Experience:

• 5-8 years of experience in a regulated, manufacturing environment within the biotechnology or pharmaceutical industry.
• Minimum of 4 years of experience working in a computer system validation or quality assurance role.
• Experience in GAMP-5 category 3, 4, and 5 computer system validation
• Experience with Quality Systems (e.g. change control, deviations, testing defects, CAPA)

Education:

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, IT, Information Systems Management, or a related field.

Knowledge, Skills, Abilities

• Knowledge of quality and IT frameworks, approaches, tools, and methodologies (i.e., GAMP, ISO, ITIL, SDLC, COBIT, Computer Software Assurance (CSA) etc.)
• Understanding of Quality, Regulatory and Compliance best practices including knowledge of 21 CFR Parts 11, 210, 211 requirements, Data Integrity, ICH Q7A requirements, and GAMP 5
• Must have an advanced understanding of the validation and qualification lifecycle and all applicable phases including planning, testing, reporting and change control.
• Able to analyze and propose solutions for compliance issues and deviations.
• Able to manage multiple priorities, projects, deliverables, and stakeholders.
• Excellent written and verbal communication skills; excellent technical writing skills.
• Strong interpersonal skills and the ability to work in a team environment.
• Experience in the use of Application Lifecycle Management (ALM) or other automated testing tools is desirable.
• Knowledge of the Agile software development processes is desired but not required.
• Proven ability to work in an FDA-regulated (GXP), fast-paced, large company environment.
• Ability to work effectively in a fast-paced geographically dispersed team.

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