101 21 Cfr Jobs - Page 3

Role & responsibilities Job Description -Software Quality Engineer (QA/RA) Design, develop, and optimize high-performance SAMD applications using SIMD for real-time. Ensure all software development complies with regulatory standards such as IEC 62304, ISO 13485, FDA 21 CFR Part 820, and EU MDR. Collaborate with cross-functional teams (RA/QA, Software/firmware development, and R&D teams) to ensure the software meets safety and performance requirements. Create and maintain documentation such as SDLC deliverables, Risk management files, Verification and Validation protocols, Usability, and Cybersecurity deliverables. Participate in internal audits, regulatory submissions, and post-market survei...

Roles and Responsibilities Conduct quality reviews of documents, including CAPAs, change controls, and 21 CFR compliance. Ensure adherence to company policies and procedures through document review. Develop and maintain a thorough understanding of regulatory requirements for pharmaceuticals. Provide feedback on document quality and suggest improvements where necessary. Collaborate with cross-functional teams to resolve issues related to document control.

Roles & Responsibilities: Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications. Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Contribute to test automation scripting, framework mainte...

I nviting 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 p...

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, repo...

You will be responsible for designing, developing, and commissioning PLC and HMI/SCADA solutions for our clients Siemens, AllenBradley, Mitsubishi ,Delta ,Siemens WinCC, FactoryTalk View & RSLogix5000 Mail to: Svsivaram@svue tech Call 9346660109 Required Candidate profile Bachelor’s degree in Electrical/Electronics/Instrumentation Engineering (B.Tech/BE). 3–5 years of handson experience in PLC/HMI/SCADA programming and commissioning. Ladder Logic, (FBD), (ST), SFC.

CSV L1/L2 Support Validating, Reviewing and updating validation documentation Hands on exp in CSV principles and GxP compliance. Experience in validation practices with hands on exp in 21 CFR Part 11/ EU Annex 11 /GAMP 5 Guidelines /GxP Standards

Greetings from HCL! Currently Hiring for "Validation" JD: Computer System Validation (CSV) Good Documentation Practices (GDP) Regulatory Compliance (GxP, FDA 21 CFR Part 11, EU Annex 11) Risk Assessment & Management & SDLC Experience - 5-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda...

Experience in CSV, GAMP, GXP, 21CFR, Part11. Experience in Documentation Writing Good Communication skills. NP - Immediate to 15 Days

Role & responsibilities 1) To perform the analysis by following cGMP, GLP, ALCO+, and safety compliance 2) To perform the sampling, testing of RM, PM, In-process, Intermediate and Finished product. 3) Participate in Investigation of deviation, Incident, OOS etc. 4) To perform all qualification activities of instrument and equipment in QC Lab. 5) Aware of calibration and operation procedure for instruments ( balance, K.F, GC. UV,refratometer and viscometer etc,) 6) Experience of QC software like Tiamo 3.0, Lab solution, SCM etc. 7) Preparation of documents ( SOP, protocol etc) related to Quality control. Kindly Send CV to mail ID, jagpal.dewal@ipca.com vishal.rankham@ipca.com

Responsibilities: *HPLC, ELISA , colorimetry & spectrophotometry, *Protein estimation, Biological assays * Electrophoresis techniques, Anticomplementary activity, *Fc function, Factor IX assay, Thrombin assay, * QMS elements

Job description BMS Validation Project - Execution SCADA Validation Project - Execution PLC System Validation Project - Execution To Handle the site engineers as per the project given by Head / Senior To prepare the work reports related to projects

Responsibilities: *HPLC, ELISA , colorimetry & spectrophotometry, *Protein estimation, Biological assays * Electrophoresis techniques, Anticomplementary activity, *Fc function, Factor IX assay, Thrombin assay, * QMS elements

Purpose of the role: The Design Quality Engineer will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance. Roles & Responsibilities: Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366). Participate in design reviews and provide quality engineering support throughout the product development lifecycle. Establish and maintain Design History Fil...

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

We are looking for skilled Automation Engineers with experience in pharmaceutical projects and hands-on involvement in DCS and PLC-based industrial automation systems . The ideal candidate should be familiar with various communication platforms , automation technologies , and GAMP protocols . Key Responsibilities: Execute and manage automation projects in pharmaceutical environments. Design, configure, and implement DCS systems for process automation. Work with industrial communication protocols (e.g., Modbus, Profibus, Ethernet/IP). Ensure compliance with GAMP guidelines and validation processes. Collaborate with cross-functional teams for project execution and documentation. Participate in...

Role & responsibilities We are looking a candidate who can work independently at our API Mfg plant which will cover IT Infra, CSV, ERP implementation, GMP compliance, etc. Implementation and roll out of all IT Application and Infrastructure initiatives at the site Deployment, monitoring, maintenance, security, data backup, development, upgrade, and support of all IT systems including Servers, Telephones, network elements, PCs. Operating systems, hardware, software, and other peripheral equipment. Responsible for day-to-day system administration, including management of internal network, VPN, Microsoft Active Directory (AD) and system backups. Implement IT policies, procedures, and best pract...

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAM...

You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. Job description: Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP) Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) Good understanding of system and data risk assessment General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage. Ability to work collaboratively in cross-functional and agile teams to achieve milestones an...

Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 2...

Well experience Computer system validation (CSV) in API/formulation organisation, Preparing all validation document (i.e URS, GxP assessment & SLRA, Configuration specification, IQ, OQ, PQ, RTM, VSR, DRP) through validation tool as per GAMP 5 & 21 CFR Compliance or Manufacturing and Quality Control Laboratory Equipment. Validate newly/upgraded software in QC Laboratory/manufacturing. Preparation periodic review & Vendor Assessment for Manufacturing and Quality Control Laboratory Equipment Initiate QMS document in Manual/Software base i.e : CCF, Risk assessment, Deviation etc. Solving the issue occurred during the execution. Data Migration and System Retirement activity triggered for manufact...

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards . Accountabilities Interfaces with customers and vendors representing company...

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Interfaces with customers and vendors representing company ...

We are seeking a skilled and proactive Medical Device Cybersecurity Engineer to join our team. This position plays a critical role in ensuring the cybersecurity and regulatory compliance of our connected medical devices throughout the product lifecycle. The ideal candidate has hands-on experience in threat modeling, managing third-party software components, performing vulnerability scans and penetration testing, and collaborating across cross-functional teams to integrate robust cybersecurity controls in accordance with FDA and global regulatory requirements. Key Responsibilities: Perform and maintain comprehensive threat modeling (e.g., STRIDE) for embedded and connected medical devices. Pe...