
Manual Test Engineer(On Contract)
Qinecsa Solutions • India
Role & seniority: Manual Test Engineer (contract, 6 months)
Stack/tools: Manual testing; SQL; Argus validation; Pharma/Life Sciences domain knowledge; familiarity with GAMP 5, 21 CFR Part 11, Annex 11; Product Validation Lifecycle; Change Control; defect management; basic test automation awareness
Top 3 responsibilities
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Validation expertise on PV applications; define test scenarios based on requirements; author/review OQ/UAT test cases
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Execute test cases; requirements analysis; risk assessment and mitigation
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Manage life cycle of qualification documents (IQ, OQ, UAT)
Must-have skills
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3–4 years in manual testing with validation understanding
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SQL knowledge
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Familiarity with pharmaceutical/ Life Sciences/Drug Safety domain
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Understanding of validation processes and regulatory guidelines (GAMP 5, 21 CFR Part 11, Annex 11)
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Product Validation Lifecycle and defect management; change control procedures
Nice-to-haves
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Knowledge of test automation frameworks
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Strong written/verbal communication; analytical and critical thinking
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Ability to influence others; adaptable in ambiguous environments
Location & work type
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Contract role; 6-month engagement
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Location not specified; remote/hybrid not specified
Full Description
We are hiring for Manual Test Engineers on contract basis for 6 months. Candidate should have a minimum of 3 Years experience in Manual Testing and should have worked on healthcare projects.
Title: Manual Test Engineer
Job Responsibilities
- ➢Validation expertise on PV applications
- ➢Validation and Testing (Validating the product to meet the requirements)
- ➢Define the Test Scenarios based on the requirements Authoring and Reviewing OQ/UAT Test Cases
- ➢Executing the Test Cases
- ➢Requirements Analysis, Risk Assessment, Profiling and Mitigation
- ➢Managing complete life cycle of qualification documents like IQ, OQ and UAT
Technical Competencies
- ➢SQL Knowledge
- ➢Understanding of Argus validation
- ➢Knowledge of Pharmaceutical/ Life Sciences/ Drug Safety domain and products
- ➢Knowledge of test automation and associated frameworks
- ➢Knowledge of regulatory guidelines like GAMP 5 RBA, 21 CFRPart11 and Annexure 11 and other regulatory authorities
- ➢Well versed with Product Validation Lifecycle and Defect Management
- ➢Knowledge of Change Control Procedure
Core Competencies
- ➢Excellent written and verbal communication skills
- ➢Should have 3 to 4 years of experience in manual testing and understanding of validation.
- ➢Analytical and critical thinking skills
- ➢Ability to influence others and move toward a common vision or goal.
- ➢Flexible and adaptable; able to work in ambiguous situations.
- ➢Resilient and tenacious with a propensity to persevere.
- ➢Forward looking with a holistic approach