Senior Computerized System Validation
4 weeks ago
Job Title: Senior Trainer – Computerized System Validation (CSV) & Data Integrity (ALCOA Principles)Location: RemoteJob type: Part-timeJob Summary:We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in GxP environments. The ideal candidate should have in-depth knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles , and be capable of delivering engaging, practical training to QA, QC, Manufacturing, and IT professionals.Key Responsibilities:Develop, design, and deliver training programs on Computerized System Validation (CSV) and Data Integrity (ALCOA & ALCOA+ principles) aligned with current regulatory guidelines.Train cross-functional teams on GAMP 5 lifecycle , risk-based validation approaches , Part 11 / Annex 11 compliance , and audit readiness .Conduct workshops and hands-on sessions on preparing Validation Master Plans (VMP), User Requirement Specifications (URS), Functional Specifications (FS), IQ/OQ/PQ protocols , and validation reports.Provide guidance on Data Integrity assessment, governance, risk mitigation, and remediation plans .Support in developing internal SOPs , policies , and training materials related to CSV and Data Integrity.Deliver training on Audit Trail Review , Backup/Restore validation , Change Control , and System Decommissioning .Evaluate and assess participants through tests, case studies, and practical sessions.Stay updated with evolving regulatory guidelines (USFDA, MHRA, WHO, EMA) and incorporate them into training content.Support in internal audits, gap assessments , and mock inspections related to computerized systems and data integrity.Required Skills & Competencies:Strong knowledge of GAMP 5 , 21 CFR Part 11 , Annex 11 , MHRA DI guidance , WHO TRS 1019 , and related frameworks.Hands-on experience in CSV lifecycle management , risk assessment , change control , and periodic review .Expertise in Data Integrity principles (ALCOA/ALCOA+) , data lifecycle management , and governance frameworks .Experience with LIMS, ERP, SCADA, DCS, MES, QMS, and laboratory instruments .Excellent presentation, communication, and interpersonal skills.Ability to simplify complex technical concepts into understandable, practical learning modules.Educational Qualification:B.Pharm / M.Pharm / B.Sc / M.Sc / B.E / M.Tech in Life Sciences, Computer Science, Instrumentation, or related fields.Certification in GAMP 5 / CSV / Data Integrity / Regulatory Compliance will be preferred.Preferred Background:Experience in regulated industries (Pharma, Biotech, or Medical Devices).Prior experience as a trainer, consultant, or auditor in CSV and Data Integrity domains.Exposure to global regulatory audits (USFDA, MHRA, TGA, WHO, EMA, etc.) .
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Senior Computerized System Validation
4 weeks ago
Pune, India Tek Support Full timeJob Title: Senior Trainer – Computerized System Validation (CSV) & Data Integrity (ALCOA Principles)Location: RemoteJob type: Part-timeJob Summary:We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in GxP environments. The ideal...
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Senior Computerized System Validation
4 weeks ago
Pune, India Tek Support Full timeJob Title: Senior Trainer – Computerized System Validation (CSV) & Data Integrity (ALCOA Principles) Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in GxP environments. The...
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Senior computerized system validation
4 weeks ago
Pune, India Tek Support Full timeJob Title: Senior Trainer – Computerized System Validation (CSV) & Data Integrity (ALCOA Principles)Location: RemoteJob type: Part-timeJob Summary:We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in Gx P environments. The ideal...
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Senior Computerized System Validation
4 weeks ago
Pune, India Tek Support Full timeJob Title: Senior Trainer – Computerized System Validation (CSV) & Data Integrity (ALCOA Principles) Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in GxP environments. The...
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Senior Computerized System Validation
4 weeks ago
Pune, India Tek Support Full timeJob Title: Senior Trainer – Computerized System Validation (CSV) & Data Integrity (ALCOA Principles)Location: Remote Job type: Part-timeJob Summary:We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in GxP environments. The ideal...
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Senior Computerized System Validation
4 weeks ago
Pune Division, India Tek Support Full timeJob Title: Senior Trainer – Computerized System Validation (CSV) & Data Integrity (ALCOA Principles) Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in GxP environments. The...
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Senior Validation Associate
2 weeks ago
North Goa, Pune, Vadodara, India Ivy Works Full time ₹ 5,00,000 - ₹ 15,00,000 per yearRole & responsibilities:Developing Validation Documentation and support for computerized systems used in GLP, GMP and GCP environments. (Manufacturing and Laboratory Systems)Developing Validation Documents and Execution of Validation Protocols.Validation Documentation will encompass validation plans, specifications, test protocols and standard operation...
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Computer System Validation Consultant/AM
3 days ago
Pune, Maharashtra, India Talworx Solutions Full time ₹ 15,00,000 - ₹ 25,00,000 per yearRole & responsibilitiesSupport on IT quality systems framework design and implementationManaging the reviews and assessments for IT qualityAssist in Computer System Validation (CSV) compliance of GxP processes forpharmaceutical companies or experience on quality compliance services for global consumerhealth care, medical devices, and pharmaceutical...
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CSV Validation Engineer
1 week ago
Pune, Maharashtra, India E Tech Group Full time ₹ 15,00,000 - ₹ 25,00,000 per yearAt E Tech Group, joining our team means joining a group of passionate and forward-thinking experts. We're one of the largest engineering and system integration firms in the United States providing value for our clients through IT automation and control solutions for more than 30 years to the Life Sciences, Mission Critical, Metals & Mining, Warehousing &...
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Senior Specialist, Digital and Data QA-3
3 days ago
Pune, Maharashtra, India MSD Full time ₹ 20,00,000 - ₹ 25,00,000 per yearJob DescriptionAs part of the Global Quality team the Senior Specialist QA will be responsible for:Managing systems to ensure quality, regulatory and GMP compliance expectations byEnsuring that all tasks are performed in accordance with quality policies and procedures, satisfy the requirements of cGMP and are in accordance with the appropriate regulatory...
