43 21 Cfr Jobs

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 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.

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, reporting status, resolving issues, and addressing change orders as they apply Minimum Requirements: Minimum degree requirement - Bachelor's degree with at least 10+ years of experience Must be willing to travel regionally and/or nationally throughout India Candidates must have excellent verbal communication and technical writing skills Experience in generation and execution of protocols and procedures related to different areas of qualification and validation Expertise in ISPE GAMP5, ICH Q8, ICH Q9, ICH Q10, 21 CFR Part 11, Computerized System Validation, Equipment Qualification, and Validation Change Control Working knowledge of protocol development for validation of complex computer systems (e.g., multiple GAMP classes of systems); ability to develop Installation, Operational, and Performance Qualification documents Experience in execution of system validation lifecycle deliverables Experience in project execution within at least one area of systems validation (e.g., laboratory equipment, facilities utilities, manufacturing equipment) Proficient in Microsoft Word, Excel, Power Point, and Project Ability to plan and manage own work All candidates must be legally eligible to work in India

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.baby@hcltech.com

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 Files (DHF) and Risk Management Files (RMF). Conduct design verification and validation activities, ensuring product safety and efficacy. Develop and implement risk management activities including Failure Mode and Effects Analysis (FMEA). Collaborate with cross-functional teams to ensure effective design transfer from R&D to manufacturing. Support the creation and review of technical documentation, including design inputs/outputs, specifications, and reports. Manage non-conformances, CAPAs, and change management activities related to design quality. Provide guidance on regulatory requirements and standards related to orthopedic implant design. Participate in internal and external audits, including regulatory inspections.

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 FAT/SAT and provide technical support during commissioning. Desired Candidate Profile: Bachelors degree in Instrumentation, Electronics, or related engineering field. 4+ years of experience in pharmaceutical automation projects. Hands-on experience with DCS/PLC systems (e.g., Siemens, Rockwell, ABB). Familiarity with SCADA/HMI systems and GAMP protocols. Strong analytical and troubleshooting skills. Good communication and team collaboration abilities.

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 practices, working closely with management to help maintain compliance on all IT infrastructure and applications as needed. Plan and coordinate IT-related activities, provide direction and support for daily and mission-critical operational activities of the IT department. Work with users to define business and system requirements for new technology implementations. Coordinate with cross-functional module leads and continuous monitoring and system development. Thorough understanding of CSV process, GMP Compliance, CFR compliance, etc. Management of IT Infrastructure (Servers, Virtualization, software, Network and RDBMS) Stakeholder & Vendor Management ERP Implementation & UAT for various modules i.e. Manufacturing, HRMS, Quality, etc. Working Location : Zekda, Dist: Bavla, Ahmedabad

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, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

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 and goals Effective communicator with excellent verbal and written communication skills - English language mandatory Assertiveness and ability to work with diverse personalities/cultures Lets find out what a usual day of work might look like. You will: Determine validation approaches, and identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systems Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures Support in deviation investigations to identify root causes and define corrective and/or preventative actions Support system audit/inspection preparation and execution as CSV subject matter expert Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready Support system periodic reviews according to company procedure We offer: dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.) a workplace that supports innovation and new ideas attractive benefits & business travel opportunities work in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrow

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 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.

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 manufacturing system. Experience of SOP preparation Preparation of inventory list, periodic review schedule, periodic review report Designation : Executive/Senior Executive Experience: 05 - 09 years

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 as Quality champion. Formulates and maintains quality assurance objectives complementary to corporate policies and goals. Designs and implements quality assurance training programs to key personnel in conjunction with managers. Prepares and maintains control plans and revises/audits processes, responds to customers quality concerns. Manage client and regulatory authority audits Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for entire organization Author or Review validation documentation (plans, protocols, test suites, reports, etc.) . Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented. Coordinates client specific validation activities with practice leads. Enforce QA requirements for IT quality systems with potential GxP impact. Support GxP decisions/strategies during validation projects . Document applicable deviations and documentation anomalies for computer systems undergoing validation. Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met. Review requirements, traceability matrices, test suites and test executions . Travel involved. Other duties as assigned. KRA spread: QMS and corporate Quality management: 60% Validation: 40%

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 as Quality champion. Formulates and maintains quality assurance objectives complementary to corporate policies and goals. Designs and implements quality assurance training programs to key personnel in conjunction with managers. Prepares and maintains control plans and revises/audits processes, responds to customers quality concerns. Manage client and regulatory authority audits Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for entire organization Author or Review validation documentation (plans, protocols, test suites, reports, etc.). Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented. Coordinates client specific validation activities with practice leads. Enforce QA requirements for IT quality systems with potential GxP impact. Support GxP decisions/strategies during validation projects. Document applicable deviations and documentation anomalies for computer systems undergoing validation. Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met. Review requirements, traceability matrices, test suites and test executions. Travel involved. Other duties as assigned. KRA spread: QMS and corporate Quality management: 60% Validation: 40% Location - Madhapur, Hyderabad, Telangana,

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. Perform regular vulnerability scans, penetration testing , and static/dynamic analysis using tools such as Kali Linux, Metasploit, Wireshark, NMAP, Fortify, Nessus, or similar. Develop and update cybersecurity risk assessments as part of the overall risk management process (including CVSS scoring). Define, implement, and document security controls based on threat model outcomes. Manage and maintain Software Bill of Materials (SBOM) in compliance with FDA premarket and post-market guidance and global standards (e.g., NTIA, NIST). Support secure software development lifecycle (SDLC) practices including secure coding reviews. Conduct cybersecurity surveillance for new threats, advisories, CVEs, and zero-day vulnerabilities that may impact devices post-market. Triage and assess reported vulnerabilities, coordinate remediation and update documentation accordingly. Support preparation of cybersecurity documentation for FDA submissions (e.g., premarket submissions, 510(k), PMA) including security risk management reports and architecture diagrams. Ensure compliance with FDA applicable standards (e.g., ISO 14971, IEC 62304, ANSI/AAMI SW96:2023) Collaborate with Quality, Regulatory, and Engineering to ensure cybersecurity is integrated across the product lifecycle. Collaborate with software, hardware, and systems teams to guide cybersecurity design and testing. Qualifications Required: Bachelors or Masters degree in Computer Engineering, Cybersecurity, Electrical Engineering, or related field. 57 years of experience in embedded systems or medical device cybersecurity. Strong working knowledge of SBOM, SOUP, vulnerability scanning tools, penetration testing, and threat modeling methodologies. Familiarity with relevant regulations and standards (e.g., FDA Cybersecurity Guidance, NIST SP 800-53/30/218, ANSI/AAMI SW96:2023). Experience with secure development tools and CI/CD environments. Preferred: Certified Ethical Hacker (CEH), CISSP, CSSLP, or similar certification. Experience with connected devices (IoMT), wireless protocols (BLE, Wi-Fi), and cloud security principles. Familiarity with DevSecOps practices and security tools integration.

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.

Role & responsibilities Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per V Model for IT projects Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes. A team player with good communication skills (verbal & written) Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, GAMP 5 (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience of working at Pharma Site QC, QA, IT, CSV etc. (Plus) Preferred candidate profile from pharma Company ro worked for pharma on 3rd party for atleast 3 yrs Contact Interested candidates can share there updated cv at ankita@topgearconsulatnts.com

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time Software Testing Manager to join our Information Technology team in Mumbai. This position will manage a team of software testing engineers and software validation projects to implement effective and high quality software solutions. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across almost 40 countries. Responsibilities Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test Plans, User Requirements & Functional Specifications, Functional & User Acceptance Testing, Traceability Matrices, and Validation Summary Reports; Coordinate and assign systems and projects to validation staff according to priorities, timelines and availability; Maintain oversight of validation staff in managing change control of Medpace software applications; Ensure compliance of Medpace computer systems with GxP and SOx regulatory requirements; Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements; Ensure consistency of systems validation SOPs with best practices of industry; Lead validation team in implementing tools and procedures to facilitate validation and documentation activities; and Participate in Sponsor audits. Qualifications Bachelor's Degree; 7+ years of experience in SDLC, testing, and validation, preferably in an Agile environment and/or regulated industry; Advanced knowledge of software development life cycle; Knowledge and understanding of the application of Risk Management concepts; Excellent analytical, written, and oral communication skills in English; Previous supervisory experience is preferred; and Experience in the regulated healthcare industry, with working knowledge of Good Clinical Practice and 21 CFR Part 11, is a plus! People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.