- 10years Experience in Validating SAP systems in Manufacturing
- Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems
- Perform review for GxP systems to ensure compliance with regulatory requirements
- Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis
- Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology
- Reviews - Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability
- Ensures Risk Assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements
- Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement
- Ensures pre-executed test protocol has the necessary test data requirements to run the tests
- Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process
- Able to author Validation Plan and compile Validation Summary Report and generates RTM
- Reviews and ensures that the Operational Procedure for the application is ready
- Is able to handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM
- Prior experience in using tools like ALM, DMS and JIRA
- Good to have experience in implementing US-DSCSA
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Compliance Lead
3 weeks ago
Talent Groups King of Prussia, United StatesJob Description: · Roles and Responsibilities – Compliance Lead · 10years' Experience in Validating SAP systems in Manufacturing · Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems. · Perform review fo ...
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Compliance Lead
4 weeks ago
Themesoft Inc. King of Prussia, United StatesJob Title:Compliance Lead · Location:King Of Prussia, PA (Hybrid Onsite) · Duration: Long Term Contract · Job Description: · 10years' Experience in Validating SAP systems in Manufacturing · Experienced in CSV activities in Manufacturing related applications like SAP Systems, ...
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Compliance Lead
3 weeks ago
ThemeSoft King of Prussia, United StatesJob Title: Compliance LeadLocation: King Of Prussia, PA (Hybrid Onsite)Duration: Long Term ContractJob Description:- 10years Experience in Validating SAP systems in Manufacturing- Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serial ...
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Compliance Solutions Lead
3 weeks ago
GlaxoSmithKline King Of Prussia, United StatesSite Name: Upper Merion, UK - Essex - Harlow, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence · Posted Date: May 6 2024 · With increasing needs in Quality, Compliance, and Safety, the harmonization, simplification and accelerati ...
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SAP Compliance Lead
1 week ago
ApTask King Of Prussia, United StatesOnly W2-Contract Location: King of Prussia, PA (Onsite/Hybrid) · Must have skill(s): CSV, SAP Validation, Product Serialization, DSCSA · Job Description: Roles and Responsibilities SAP Compliance Lead · 10years Experience in Validating SAP systems in Manufacturing · Experienced ...
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Compliance Solutions Lead
3 weeks ago
GlaxoSmithKline King of Prussia, United StatesSite Name: Upper Merion, UK - Essex - Harlow, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper ProvidencePosted Date: May 6 2024With increasing needs in Quality, Compliance, and Safety, the harmonization, simplification and acceleration of ...
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CSV Compliance Lead
1 week ago
CYNET SYSTEMS King of Prussia, United StatesJob Description: · Pay Range: $60hr - $65hr · Responsibilities: 10years Experience in Validating SAP systems in Manufacturing. · Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems. · Perform re ...
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CSV - Compliance and Validation Testing Lead
3 weeks ago
Recmatrix Consulting King of Prussia, United StatesJob Title: Compliance Lead · Contract Duration: 6 months, extendable · Location: King of Prussia, Pennsylvania. · Working model: Onsite/Hybrid · Required Skills: CSV, SAP Validation, Product Serialization, DSCSA · Roles and Responsibilities: · Perform review for GxP systems to e ...
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Compliance Solutions Lead
3 weeks ago
GlaxoSmithKline Collegeville, United StatesSite Name: · Upper Merion, UK - Essex - Harlow, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence · Posted Date: · May 6 2024 · With increasing needs in Quality, Compliance, and Safety, the harmonization, simplification and acce ...
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Compliance Solutions Lead
3 weeks ago
GlaxoSmithKline Collegeville, United States Full timeSite Name: Upper Merion, UK - Essex - Harlow, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence · Posted Date: May 6 2024 · With increasing needs in Quality, Compliance, and Safety, the harmonization, simplification and accelerati ...
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Compliance Lead
1 week ago
Tekfortune Inc Philadelphia, United StatesTekfortune is a fast-growing consulting firm specialized in permanent, contract & project-based staffing services for world's leading organizations in a broad range of industries. In this quickly changing economic landscape, virtual recruiting and remote work are critical for the ...
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Product Regulatory Manager
1 week ago
Arkema King of Prussia, United States**Product Regulatory Manager - Americas Chemical Management Regulatory Programs** · Lead team of one direct report to provide in-depth regulatory, technical and program guidance and expertise to Arkema Inc. business units, operating locations, staff groups and company facilities ...
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Industrial Demolition Project Supervisor
1 week ago
Stryker DES King of Prussia, United StatesStryker DES offers competitive wages based on experience and a benefits package including medical insurance, dental insurance, life insurance and employer matched 401k. · RESPONSIBILITIES: · - Supervise work crews, ensuring efficient and effective completion of project objectives ...
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Human Resources Manager
3 weeks ago
Genesis Community Homes, LLC King of Prussia, United States**Benefits**: · - Company parties · - Dental insurance · - Health insurance · - Opportunity for advancement · - Paid time off · **Benefits/Perks** · - Competitive Compensation · - Great Work Environment · - Career Advancement Opportunities · **Job Summary** · **Responsibilities** ...
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Retail Full Time Key Holder Fenty
2 weeks ago
Savage X King of Prussia, United States Full timeJob Description · WHO WE ARE · - At Savage X Fenty, we are all about disrupting the fashion industry and redefining sexy We celebrate fearlessness, confidence, and inclusivity with accessible price points and an extensive assortment of fashion-forward styles. From everyday staple ...
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Paste Technician
1 week ago
Vibrantz Technologies King of Prussia, United StatesCompany Overview · Vibrantz Technologies is a leading global provider of specialty chemicals and materials solutions whose purpose is to bring color, performance, and vibrancy to life. Every day, our employees, the products we make, and our valued customer partnerships are inspir ...
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Director of Operations- Mission Center
2 weeks ago
Recovery Centers of America King of Prussia, United States**Position Overview**: · The Director of Operations is responsible for overseeing all aspects of the Team Lead team and Overnight team including the management of the team P&L. This role is responsible for developing and executing strategies to maximize admissions into programs, ...
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Assistant General Counsel
1 week ago
Arkema King of Prussia, United StatesThe** Assistant General Counsel - Litigation/Environmental **position will reports to the Deputy General Counsel - Litigation & IP. It will manage and oversee various types of litigation, including but not limited to PFAS, toxic tort, product liability, environmental remediation, ...
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Regional Contracting Operations Leader
3 weeks ago
Trane Technologies King of Prussia, United StatesAt Trane TechnologiesTM and through our businesses including Trane and Thermo King, we create innovative climate solutions for buildings, homes, and transportation that challenge what's possible for a sustainable world. We're a team that dares to look at the world's challenges an ...
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Ems Scheduling Coordinator
3 weeks ago
DocGo King of Prussia, United StatesTitle: EMS Scheduling Coordinator · Employment Type: Full-Time · Pay Rate: $ $22.50 per hour · Schedule: Must have open availability · Location: King of Prussia, PA · Benefits: Medical, Dental, and Vision (with company contribution), Paid Time Off, 401k · About DocGo: DocGo is le ...
SAP Validation/Product Serialization Compliance Lead - King Of Prussia, United States - Deltaclass Technology Solutions Limited
1 week ago
Description
SAP Product Serialization Compliance Lead
Location: King of Prussia, PA (Onsite/Hybrid)
Must have skill(s): CSV, SAP Validation, Product Serialization, DSCSA
Job Description: Roles and Responsibilities