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Careers

Current Job Openings

To Apply for any of these jobs, reach out to us via email at Careers@Sixsigmasolutionspvtltd.com with Job Code, your resume & CV.

Job Code: JSS-VE-82AO45

Job Title: Validation Engineer II

Basic Qualifications:

Summary:

A validation engineer is responsible for ensuring that a product or system meets the required specifications and standards. This position will conduct various tests and procedures to validate the functionality, performance, and reliability of the product. The position works closely with the design and development teams to understand the requirements and identify any potential issues or risks. You will also analyze test results and provide recommendations for improvements or modifications. Additionally, the validation engineer may collaborate with regulatory agencies to ensure compliance with industry standards and regulations. This role requires strong analytical skills, attention to detail, and the ability to work in a team environment.

Responsibilities:

Documentation Preparation (Validation plans, User Requirement Specifications, Functional Specifications, Risk Assessments, Traceability Matrices, Protocol and Report Generation) (50%).
Protocol Execution (40%).
Change Control validation assessments for Computerized Systems (5%).
Training personnel in CSV practices (5%).
Annual evaluation of GMP Computerized Systems.
Strong background in IT systems and strong knowledge of cGMP and validation regulations and requirements.
Knowledge of GMP, GLP, GDP, pharmacopeial and regulatory requirements.
Detail oriented with strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.

Job Code: JSS-VE-53YL46

Job Title: Sr. Validation Engineer

Basic Qualifications:

Summary:

The Senior Computerized System Validation Engineer will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation and Lifecycle procedures with Data Integrity requirements.

Responsibilities:

Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
Experience of CSV Validation in Lab systems (LIMS, CDS, SDMS etc) and any diagnostic software like QPCR, QxMGR is added advantage.
Should worked in pharmaceutical domain and its related knowledge is must.
Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle.
To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas.
Preferred Experience in Agile Development.
Knowledge on working in Jira / Service Now.

Job Code: JSS-DA-23YH30

Job Title: Data Engineer

Basic Qualifications:

Master of Science degree (or equivalent conferred degree) in software or computer Engineering, or equivalent program and 4 to 7 year of experience in above described system testing.

Summary:

Execute all programming tasks, including programming, analyzing, designing, developing, implementing, modifying, and maintaining computer programs. Work on systems of small to moderate size and complexity or segments of larger systems.

Responsibilities:

ELT (extract/load/transform) processes – preparing data for modeling, building algorithms and prototypes, data cleansing.
Cloud management – work with multiple cloud-based services and tools, as well as hosted cloud providers.
Data monitoring – ensure data quality, processes, and routines are optimized for performance and efficiency.
Work within a collaborative Agile environment.
Analyze requirements and create performance, scalable database structures, objects and stored procedures.
Analyze, create and tune complex T-SQL code to ensure optimal performance and data integrity across very large data sets.
Create, modify and deploy SQL Server Integration Services packages to extract, transform and load large sets of data.
Experience with Oracle database, Elasticsearch, GitLab, MySQL, PostgreSQL, Kafka a plus.

Job Code: JSS-QA-11FK04

Job Title: Quality Associate

Basic Qualifications:

Master of Science degree (or equivalent conferred degree) in Mechanical engineering, Chemical engineering, Biotechnology/Pharmaceutical Engineering, or equivalent program and 7 to 10 year of experience. Proven experience as a Quality Assurance Software Tester or similar role with experience in project management and QA methodology. Some familiarity with Agile frameworks and regression testing.

Summary:

Assess software quality through manual and automated testing. Responsible for finding and reporting bugs and glitches. Report bugs and errors to development teams. Work with cross-functional teams to ensure quality throughout the software development lifecycle.

Responsibilities:

Review and analyze system specifications.
Execute test cases (manual or automated) and analyze results.
Evaluate product code according to specifications.
Create logs to document testing phases and defects.
Report bugs and errors to development teams.
Help troubleshoot issues.
Conduct post-release/ post-implementation testing.
Work with cross-functional teams to ensure quality throughout the software development lifecycle.

Job Code: JSS-PM-99LR75

Job Title: Project Associate II

Basic Qualifications:

Master of Business Administration (or equivalent conferred degree) in software or computer Engineering, or equivalent program. Minimum 3-5 years of experience in project management, preferably in a tech startup or related industry.

Summary:

As a Project Manager, you will be responsible for overseeing all aspects of project planning, execution, and delivery. You will collaborate closely with cross-functional teams to ensure projects are completed on time, within scope, and on budget.

Responsibilities:

Develop and maintain detailed project plans, including objectives, timelines, resources, and deliverables.
Overseeing and maintaining the operation of our Jira and Confluence environments.
Coordinate with internal and external stakeholders to ensure clear communication and alignment on project expectations and requirements.
Monitor project progress, identify, and resolve risks, and implement appropriate corrective actions when necessary.
Establish and maintain strong relationships with team members, stakeholders, and clients, promoting a culture of collaboration, accountability, and excellence.
Manage project budgets, ensuring that resources are allocated effectively, and expenditures are tracked and reported accurately.
Lead project meetings, ensuring that team members are kept informed, engaged, and motivated.
Facilitate project closure and post-project evaluations, capturing lessons learned and implementing best practices for future projects.