101 21 Cfr Jobs - Page 2

This role is part of R&D (Research & Development) focusing on Software Verification & Validation (V&V) for healthcare/medical/pharma-related systems. Key Responsibilities Perform software verification & validation to ensure compliance with medical device/healthcare software standards. Develop, execute, and automate test cases, scripts, and frameworks. Work on test planning, defect tracking, debugging, and quality assurance activities. Collaborate with cross-functional teams R&D, product engineering, and regulatory teams. Ensure compliance with ISO 13485, IEC 62304, FDA guidelines (typical in medical software). Skills & Requirements Strong background in manual + automation testing for softwar...

Role & responsibilities Must have good hands on experience in HPLC, electrophoretic test method. Should be able to handle liquid chromotography and relevent 21CFR softwares. Should have good hands on experience in cell based test method. Should be able to handle ELISA ,Microscope , basic QC instruments and revelent 21CFR software. Preferred candidate profile Jr-Executive 1-3 years experience in QC biologics Contact Person : Manasa (manasa.s@talent21.in)

Dear Candidate, WE ARE HIRING Department: - Production- DS Designation: - Dy Manager / Manager Qualification: - Preferably Post Graduation in Science Experience: - 15+ Years Age: - Between 35- 40Years Mandatory: - Should come in all shifts, including Night shifts Role: Shift-in-charge for entire DS floor Job Description: > Strong Functional knowledge of DS Biologics (Chromatography and related purification experience protein/ Insulin handling experience preferable). Capable of handling large teams as we have around 45 members in each shift, around 50% of contractual staff. Strong administration / team management capabilities to streamline GMP across the floor. Monitoring the efficiency of em...

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

Responsibilities: Ensure compliance with regulatory requirements through CSV processes. Implement LIMS, Labware Lims & DMS systems. Conduct CSV activities for equipment validation. Health insurance Annual bonus Provident fund Flexi working

As a CSV (Computer System Validation) Consultant/ Lead your responsibilities includes developing validation plans, protocols, and test scripts; executing tests; performing risk assessments; documenting all processes; and ensuring that systems adhere to regulatory requirements throughout the lifecycle. Required Skills and Qualifications Technical Skills: Proficiency with validation software (e.g., MS Project, ALM, Veeva Vault) and an understanding of manufacturing and supply chain applications. Regulatory Knowledge: Strong understanding of GxP, FDA regulations, and other relevant industry standards. Analytical and Problem-Solving Skills: Ability to assess systems for quality and compliance, a...

Manufacturing Systems & Compliance Support manufacturing and laboratory systems (e.g., LIMS, MES, SCADA, PLCs, BAS, and ERP). Ensure IT systems comply with GxP regulations and 21 CFR Part 11. Support and maintain including documentation as per SOPs Required Candidate profile IT experience in a manufacturing environment (pharma preferred). Familiarity with GMP, GAMP5, and regulatory units (FDA, EMA). Supporting validated systems and documentation for audits/inspections. Perks and benefits Accommodation & Transportation

Position Overview: We are seeking a knowledgeable and results-driven CSV Engineer to join our team, specializing in providing expert validation services to our clients. In this role, you will work closely with a diverse range of companies, ensuring the compliance, reliability, and quality of their computerized systems while adhering to industry regulations and best practices. Key Responsibilities: Validation Strategy and Planning: - Collaborate with clients to develop tailored validation strategies and plans based on their specific needs and regulatory requirements. - Assess project scope, goals, and timelines to design efficient validation approaches. Validation Execution: - Design, develop...

Education Qualification: Bachelors degree in Computer Science, Engineering or Natural Science Professional Experience & Responsibilities: Minimum experience of 8+ years on MES PAS-X application V3.1.8, V3.2.7 and V3.3.2. Having a good hold on MES PAS-X Master Data Parameterization (Equipment Management, User Management, Rights Management, Control Data, Terminal Management, Printing/Reporting, Profiles, Production Units, WMS Master Data, and Service configuration. Having good knowledge of PAS-X functionality like weighing & dispensing module, equipment management, MBR design, and EBR and materials management/warehouse functionality Knows MES integration with Level 2, Level 3, and Level 4 syst...

About Stelda Designation - Senior Design Engineer At STELDA, we are committed to providing reliable industrial packaging solutions that are stronger, more secure, and sustainable. Powered by innovative packaging technology, our solutions are tailored to meet the unique requirements of global brands. With 30 years of expertise in adhesive applications using advanced machinery on natural substrates like paper, we take pride in leading packaging automation and dominating the graphic arts industryspecializing in bookbinding across South Asia and Africa. In collaboration with global pioneers like Nordson and Henkel Adhesives, we provide reliable industrial packaging solutions and comprehensive au...

Responsible for implementation, and effectiveness of Validation 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, compliance related activities (ICH, 21 CFR, GPDR etc), 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 Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 r...

Job Role Job Summary: We are seeking a skilled and proactive LabVantage Support Specialist to provide technical and functional support for the LabVantage LIMS (Laboratory Information Management System). The ideal candidate will have hands-on experience in LabVantage configuration, troubleshooting, and user support, ensuring smooth operation and optimal performance of the system across laboratory operations. Key Responsibilities: Provide day-to-day support for LabVantage LIMS users, including issue resolution, troubleshooting, and guidance. Monitor system performance and ensure uptime, data integrity, and compliance with regulatory standards. Configure and maintain LabVantage modules, workflo...

JOB Description- Role- Computer System Validation Consultant Location- Dadra Responsibilities- 1. Expertise in computer system validation, QMS and IT Compliance. 2. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9. 3. Validation experience and expertise in manufacturing, QC and enterprise systems. 4. QMS: Initiation/Review of change management, Investigation, CAPA, Deviation etc. 5. Review the IT activities- Backup report, user access management, Support in internal audit and IT Compliance management. 6. The candidate should have experience in SOP preparation and review. 7. Project and stakeholder management. 8. Periodic review and IT schedule activity management 9. Excellent v...

Job description JOB RESPONSIBILITIES 1) To ensure & carry out daily instrumentation maintenance, breakdown & project work based on requirement. 2) To ensure CGMP / EHS and site SOPs are strictly followed during execution of Projects & Maintenance activities. 3) To assist in Preparation of SOPs & Qualification documents for Department. 4) To ensure the instrument inventory with engineering store. 5) To attend the inter departmental, EHS, QA training as per schedule & maintain training record of the same. 6) To train the subordinates for departmental SOPs. 7) To prepare the calibration schedule, maintain the calibration certificate & its master instrument certificate at site. 8) To maintain th...

We are seeking a meticulous AQA - Data Reviewer to conduct quality reviews of key pharmaceutical documents and ensure compliance with regulatory standards, including 21 CFR. The ideal candidate will collaborate with cross-functional teams to maintain document integrity and support continuous quality improvement. Key Responsibilities: Conduct thorough quality reviews of documents such as CAPAs (Corrective and Preventive Actions), change controls, and ensure compliance with 21 CFR regulations. Ensure adherence to company policies and standard operating procedures through detailed document reviews. Develop and maintain a comprehensive understanding of pharmaceutical regulatory requirements. Pro...

Key Role and Responsibilities: Should have experience in CSV (Computer System Validation) in Life Sciences domain. Should have good knowledge of GxP regulations and GAMP 5 Guidelines. Should have a good knowledge of 21 CFR part 11 and EU Annex 11 regulations. Should have experience in defining the validation strategy, approach, and alignment with customer on QMS. Should have good knowledge of Good Documentation Practices. Should have experience in authoring of CSV deliverables such as Validation Plan, Test Plan, RTM, Test Summary and Validation Summary Report, GxP Assessments, 21 CFR Part 11 assessments and System Release Notice. Should have experience of Validating Safety Systems. Should ha...

Role & responsibilities 1. Managing the quality documents and conducting internal Audit & data review etc. 2. Maintaining all records and documentation as per 17025:20053. 3. Maintaining regularly and tracked calibration and standard log books, 4. Directing all quality activities for the laboratory such as ILC, IQC, Training, etc. 5. Preparing compliance report for the audit or for the closure of various shortcomings or NCs. 6. Having sound knowledge of QMS and LIMS. 7. Knowledge of 21cfr, OOS, Market complaints, APQR.

Role & responsibilities He must have Experience in Tablet Compression Machine Service application. He had work on Tablet Compression machine manufacturing industry. He must have knowledge of 21 CFR compliance report and necessary document for compression machine. He will be responsible to attend customer call, align engineer to support customer. He will be responsible to complete execution of retrofitting and upgradation of the machine in time. He will be co-ordinate with purchase; sales team for machine readiness.

Job Title Software Quality Engineer Job Description Job title: Software Quality Engineer Your role: Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design. Validates key design inputs (i.e. usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs). Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle. Can lead quality related problem solving for software. Use post-market analytics and statistics ...

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 ...

EY- GDS Consulting Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with ...

He will be responsible for giving online support for SCADA for compression/coating/ tool polish machines. He must have skill of ladder/structure text for PLC programming He must have skill of SQL, Database reporting structure, 21 CFR compliance report He must have skill of indusoft/AVEVA/Eco structure machine expert SCADA. Comfortable to work in 2 shift

Roles and Responsibilities Manage IT infrastructure, including servers, storage, network devices, and virtualization platforms (VMware). Ensure compliance with regulatory requirements such as GXP/GMP/21 CFR Part 11 through documentation and implementation of controls. Develop and maintain CSVs (Computer System Validation) protocols for new equipment installations or upgrades. Collaborate with cross-functional teams to identify opportunities for process improvements and implement changes using tools like Anaplan. Provide technical support for IT systems, troubleshooting issues related to hardware failures or software malfunctions.

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

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...