We're #hiring a new GxP Application Administrator in Raleigh-Durham-Chapel Hill Area. Apply today or share this post with your network.
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#hiringalert #hiringnow GXP Documentation Specialist - Fully Remote Email: ajay@foxprotech.com (or) DM Ajay Skills Experience in Life Sciences domain Experience creating GxP documentation Hands on experience in procedure and process documentation creation Hands on experience in quality validation planning and execution #hiring #remote #remotejobs #lifesciences #GxP #documentation #w2 #w2jobs #usa #usaitjobs #validation #labcsv #c2c #planning #execution
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Staff augmentation — or full-time consultant resourcing — offers a flexible and efficient solution for companies needing to access specialized skills without the long-term commitment of hiring permanent employees right off the bat. Our new case study provides a look into how we've been using this model to build and grow a unique quality department. In case your time is short, here are the cliff notes: ▪ Over the past three years, The FDA Group has successfully supported a mid-sized pharmaceutical company in developing and maintaining its quality department. ▪ The company’s unique structure involves leveraging internal R&D and in-licensing compounds from various sources, allowing for rapidly advancing a diverse drug portfolio. ▪ Additionally, the company creates semi-independent subsidiaries focused on specific therapeutic areas, supported by centralized resources and expertise. ▪ Facing fluctuating workloads and the need for specialized skills, the company sought The FDA Group’s help to secure skilled full-time contracted specialists. ——— ▪ We mobilized external resources for full-time contracted roles. ⮑ Initially, a Quality Lead (Consultant A) was placed, followed by two more consultants (Consultant B and Consultant C) to provide targeted support in quality management, clinical operations, IT systems implementation, and GxP compliance. ⮑ Consultant A developed quality transition plans, performed gap assessments, managed quality integration across various areas (GMP, GCP, GLP), and identified suppliers. ⮑ Consultant B offered supplier and vendor qualification support, served as a validation lead, and implemented Veeva QMS Vault. ⮑ Consultant C led the Veeva system implementation, provided QA support for GxP IT systems, and developed training programs for new hires. —— ▪ To date, we've successfully established a functional quality department, implemented the Veeva QMS Vault across the org, and consistently supported supplier qualification, audit management, and quality needs across subsidiaries. ▪ Comprehensive training programs were developed and executed, ensuring quality processes were integrated across technical and functional lines for newly acquired assets. ▪ The engagement has seen zero turnover, with multiple contract extensions. Their ability to adapt across multiple functional areas has been particularly valuable, allowing the company to manage its fluctuating workload efficiently. ——— Flip through the whole story below and contact us to learn more about accessing full-time consultants to execute your projects on time and on budget.
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Validation and documentation most likely drive many of the decisions you're making. Same here. TARA PV is a fully tested and audited, pre-validated, web-based software system; developed and accredited with both ISO 9001 and ISO 27001 certifications. We follow a clearly pre-defined and documented software development lifecycle to ensure quality and prevent software defects. 🏆 What can be gained from pre-validation? Assurance of accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records whilst maintaining the highest level of data security. 🎯 Why is a pre-validation system favoured? We complete as much of the pre-validation and verification process as possible in order to allow for quick out-of-the-box implementation times. Not only is installation a much faster process but user acceptance testing becomes a customer preference. 📋 How is TARA PV's validation regulated? In addition to ISO accreditations, we enable 21 CFR Part 11 compliance, adherence to GxP and ICH standards and European & Worldwide regulations including GDPR. We continually work to further assure the validation of TARA PV systems including regular review & updates to our documentation library, increasing our auto testing capabilities and the adoption of the FDAs developing computer system assurance guidelines. In 2021, we introduced the capability to host TARA PV in Microsoft Azure and we continually evaluate our ability to meet specific customer requirements such as this. Asides from assuring the adherence to the most up-to-date guidelines, one of the key aspects of validation is the evidential documentation that is required - something TARA PV is well-versed at. All our customers have varying needs when it comes to documentation, so we ensure a wide list of documents and reports are available upon request. Have questions? Leave a comment, or contact our specialists via info@tarapv.com. #saas #pvsystem #safetydatabase #clinicaltrials #drugsafety #pharmacovigilance
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Hello #LinkedIn I trust this message finds all of you is well. I am reaching out to inquire if there is a current need within your esteemed organization for accomplished professionals specializing in #QualityEngineering and #ValidationEngineering within the #Pharmaceutical and #MedicalDevice industries, particularly in a #C2C (Corp-to-Corp) Contract Manner . Our team boasts a cadre of seasoned experts with extensive knowledge and hands-on experience, poised to seamlessly integrate into roles of this nature. Should you express interest, I am more than prepared to promptly furnish you with the comprehensive curriculum vitae of our skilled consultant, specifically tailored to meet your requirements. Your consideration of this matter is greatly appreciated, and I am at your disposal to provide any additional information or address queries you may have. Thank you for considering our expertise. Please feel free to share your #C2C #Requirements with me @ 9083735286 || sai@katalysthls.com #MedTechQuality #QualityEngineering #DeviceQuality #QAinHealthcare #MedicalDeviceExcellence #QEMedical #QualityAssurance #MedDeviceQA #EngineeringPrecision #QualityInnovation #ComplianceExcellence #QAPro #MedTechStandards #ValidationEngineer #QualityControl #DeviceRegulations #HealthcareQuality #QEDesign #RegulatoryCompliance #MedicalDeviceQuality #PharmaValidation #ValidationEngineering #QualityValidation #PharmaCompliance #GMPValidation #ValidationExcellence #PharmaceuticalQA #ProcessValidation #QAinPharma #ComplianceEngineering #ValidationPro #PharmaStandards #QualityAssured #RegulatoryValidation #PharmaQualityControl #cGMPValidation #QualityInPharmaceuticals #ValidationTesting #PharmaRegulations #DataIntegrityValidation #CSVValidationEngineer #PharmaValidation #PharmaCompliance #GxPCompliance #ValidationExcellence #ComputerSystemValidation #PharmaceuticalQA #GAMP5 #QAinPharma #CSVLifeCycle #ComplianceEngineering #PharmaRegulations #ValidationPro #DataIntegrityValidation #QualityAssured #CSVStandards #RegulatoryValidation #PharmaQualityControl #PharmaIT #CSVDocumentation #PharmaAutomation #QualityInPharmaceuticals #PharmaTechnology #AuditTrail #PharmaDataIntegrity #CSVBestPractices #PharmaSoftwareValidation #PharmaITCompliance #PharmaValidationProtocols #PharmaValidationLifecycle #ValidationTesting #CSVPharmaIndustry #PharmaCSVCompliance #PharmaSoftwareQA #galladurgaprasad #galladurgaprasad #galladurgaprasad #galladurgaprasad #galladurgaprasad
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hims & hers is hiring a remote Director, Regulatory Compliance #hims&hers #remotework #remotejob #workfromhome #RegulatoryCompliance #RegulatoryRequirements #QualityAssurance #Auditing #SOPs #RegulatoryAffairs #CompliancePolicies #CrossFunctionalCollaboration #RiskManagement #AttentionToDetail #Leadership #Pharmacy #DirectorOfComplianceAndRegulatoryAffairs #DirectorOfGovernanceAndCompliance #HeadOfCompliance
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Are you looking for an efficient way to find the perfect candidate to fill your business's skills gap? 🤔Look no further than a recruiter with expertise in your industry! 🎯 Recruiters are the go-to experts for matching great talent with great opportunities. Having a recruiter behind your search helps you focus your efforts and gives you an edge in the hiring market. 💪 They have the industry-specific experience and knowledge to understand the right candidate for the role, as well as the ability to quickly identify and secure the best candidates. 📈 Recruiters also know the exact steps to take in the hiring process, and can organise interviews and other necessary steps quickly and effectively. 💡 Trust in an experienced recruiter to fill your skills gap, and you'll have the ideal candidate in no time at all. We here at GxP all come from a Medical / Manufacturing background with real life experience in Validation, Quality, CSV, Automation, Project Management and Manufacturing🙌 #Recruiter #HiringProcess #JobOpportunities 🕵️♂️ 🔎 🗂
Partner with a recruiter who knows your industry!
gxprecruitment.ie
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Lead (DGM) : APl I Biocatalysis l Process development for NPD, Gx & CDMOs... (T- skilled scientist and certified PMP)
Good summary
Gxp Dictionary
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Computer System Validation (CSV) is a process used to ensure that computer systems within regulated industries, such as pharmaceuticals and biotechnology, are operating according to their intended purpose and consistently producing reliable results. The aim is to ensure data integrity, accuracy, and compliance with regulatory standards such as FDA’s 21 CFR Part 11 and EU Annex 11. Key Topics in CSV: ______________________ 1. Regulatory Requirements - Understanding regulations and guidelines (e.g., FDA, EMA) - GxP (Good Practice) compliance (GMP, GLP, GCP) 2. Validation Planning - Validation Master Plan (VMP) - Risk assessment and management - Project planning and resource allocation 3. System Requirements - User Requirements Specification (URS) - Functional Requirements Specification (FRS) - Design Specification (DS) 4. System Risk Assessment - Identifying potential risks - Determining risk mitigation strategies 5. Testing and Verification - Installation Qualification (IQ) - Operational Qualification (OQ) - Performance Qualification (PQ) - User Acceptance Testing (UAT) 6. Data Integrity - Ensuring accuracy, completeness, and consistency of data - Audit trails and data traceability 7. Documentation - Standard Operating Procedures (SOPs) - Validation protocols and reports - Change control and deviation management 8. Training and Change Management - Training personnel on validated systems - Managing changes to the system post-validation 9. Periodic Review and Revalidation - Ongoing monitoring of system performance - Revalidation after significant changes or updates 10. Electronic Records and Signatures - Compliance with electronic records regulations (e.g., 21 CFR Part 11) - Secure and compliant electronic signatures Understanding and mastering these topics are essential for anyone involved in CSV to ensure compliance and maintain the integrity and reliability of computerized systems in regulated environments. Happy learning. 😊 #ComputerSystemValidation #CSV #DataIntegrity #RegulatoryCompliance #PharmaceuticalIndustry #GxP #QualityAssurance #ValidationProcess #FDACompliance #EUAnnex11 #PharmaTech #RiskAssessment #ValidationTesting #DataTraceability #SystemValidation #PharmaRegulations
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Are you looking for an efficient way to find the perfect candidate to fill your business's skills gap? 🤔Look no further than a recruiter with expertise in your industry! 🎯 Recruiters are the go-to experts for matching great talent with great opportunities. Having a recruiter behind your search helps you focus your efforts and gives you an edge in the hiring market. 💪 They have the industry-specific experience and knowledge to understand the right candidate for the role, as well as the ability to quickly identify and secure the best candidates. 📈 Recruiters also know the exact steps to take in the hiring process, and can organise interviews and other necessary steps quickly and effectively. 💡 Trust in an experienced recruiter to fill your skills gap, and you'll have the ideal candidate in no time at all. We here at GxP all come from a Medical / Manufacturing background with real life experience in Validation, Quality, CSV, Automation, Project Management and Manufacturing🙌 #Recruiter #HiringProcess #JobOpportunities 🕵️♂️ 🔎 🗂
Partner with a recruiter who knows your industry!
gxprecruitment.ie
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