Csv Engineer @ Genpact

Job Description

Inviting applications for the role of Principal Consultant CSV Analyst

In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution.

Responsibilities

• Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met
• Evaluate proposed changes to validated computer systems and recommend level of validation activities required
• Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology
• Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
• Where applicable, ensure proper level of software documentation from suppliers (detailed software specifications, architecture diagrams, deployment specs), as well as identification of associated unit and deployment testing prior to release
• Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
• Execution of validation plans and validation documents

Qualifications we seek in you!

Minimum Qualifications / Skills

• BE/B Tech

Preferred Qualifications/ Skills

• Familiar with writing tests for Web-based software architectures
• Knowledge of Software validation process and testing methodologies, preferably in a highly regulated environment (medical, aerospace or equivalent).
• Familiarity with the processes and legal requirements for pharmaceutical or medical device industry (cGMP's, 21CFR part11, GAMP) would be a plus.
• Critical thinker and problem-solving skills
• Team player
• Good level in English
• Great interpersonal and communication skills

Looking for Immediate to 45 days joiners.

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Accounting / Finance Advertising / MR / PR / Events Agriculture / Dairy Animation / Multimedia Architecture / Interior Design Astrology Automobile / Auto Ancillaries / Auto Components Aviation / Airline / Aerospace / Aeronautical Banking / Financial Services / Broking BPO / Call Center / ITeS Brewery / Distillery Broadcasting Cement / Building Material Chemical / Petro / Plastic / Rubber / Glass Consumer Electronics / Appliances / Durables Courier / Transportation / Freight Defence / Government Education / Teaching / Training Electricals / Switchgears Engineering / Construction / Cement / Metals Environment / Waste Management Export / Import / Trading Facility Management Fertilizers / Pesticides FMCG / Foods / Beverage Food Processing Furnishings / Ceramics / Sanitaryware / Electricals Gems / Jewellery Gifts / Toys / Stationary Government / Departmental Heat Ventilation / Air Conditioning Hotel / Restaurant Industrial Design Industrial Products / Heavy Machinery Insurance Internet / E-Commerce IT - Hardware / Networking IT - Software / Services KPO / Research / Analytics Leather / Leather Products Legal / Courts Logistics / Courier / Transportation Management Consulting / Strategy Manufacturing / Production Matrimony / Matchmaking Media / Entertainment Medical / Healthcare / Hospital Merchant Navy Metal / Iron / Steel MFI - Micro Finance Military / Police / Arms Ammunition Mining / Quarrying NBFC-Non Banking Financial Services NGO / Social Work Office Equipment / Automation Not Mentioned Paint / Art / Sculpture / Craft Paper / Wood Personal Care / Beauty Pharma / Biotech / Clinical Research Politics Power / Energy / Oil / Gas / Petroleum Printing / Publishing / Packaging Quality Certification Real Estate / Property Recruitment Services / RPO Religion / Spirituality Retail Security / Detective Services Semiconductors / Electronics Shipping / Marine Telecom / ISP Textile / Garments / Fashion Travel / Tourism / Hotels / Airlines / Railways Unskilled Labor / Domestic Help Veterinary Science / Pet Care Sports / Fitness / Beauty NBFC ( Non Banking Financial Services ) Manufacturing Travel / Tourism Medical / Healthcare FMCG / F/B Education / Training IT Services / Consulting Software Product BPO / Call Center BFSI Power / Energy Recruitment Services Pharma / Biotech Oil / Gas / Petroleum Banking Real Estate Financial Services Accounting / Auditing Square 1 Consulting Services Hiring For A reputed Chemical industry Consumer Durables / Electronics Media / Dotcom / Entertainment Engineering / Construction Investment Banking / Venture Capital / Private Equity Aviation / Airline Automation Export-Import / Trading Shipping Hospitality FinTech Automobile / Auto Ancillaries Others Printing / Packaging Broking Auto Components E-Learning Furnishings / Sanitaryware / Electricals Chemical / Plastic / Rubber / Glass 97 KPO / Analytics Sanskar HR Consultancy Services Hiring For Chemical Industry Emerging Technologies MFI ( Micro Finance ) Heat ventilation Air conditioning Heat ventilation Air conditioning Subhadra Jobs Consultancy Hiring For Bpo Industry Subhadra Jobs Consultancy Hiring For Bpo Industry Acme Services Private Limited Hiring For Beauty Skin Care Industry Semiconductors Semiconductors Mining Sanskar HR Consultancy Services Hiring For Manufacturing Industry Sports / Fitness AMOHA CONSULTING AND VENTURES PRIVATE LIMITED Hiring For Urgent | Hiring for Branch Sales Manager role in NBFC Industry for Navi Mumbai - 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Keyskills:   Compliance Csv SME Computer System Validation Cfr