67 21 Cfr Jobs

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...

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