101 21 Cfr Jobs

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

Responsibilities: Product Innovation & Technical Leadership Lead design and development of advanced orthopaedic implants and instruments, focusing on innovation, clinical performance, and patient outcomes. Identify clinical needs and market trends, and translate them into product requirements through interaction with surgeons and marketing teams. Provide technical leadership for concept development, design feasibility, and prototyping. Design Execution & Validation Develop 3D solid/surface models, detailed technical drawings, and design documentation using SolidWorks, AutoCAD, CREO software and CAM tools. Conduct and review FEA(Finite Element Analysis )/CAE (Computer-Aided Engineering) analy...

Roles & Responsibilities Manage and maintain the QMS, ensuring compliance with global medical device regulations. Lead internal and external audits; ensure timely closure of findings. Oversee document control, CAPA, training, and change management processes. Monitor quality metrics and drive continuous improvement initiatives. Support regulatory inspections, product registrations, and management reviews. Collaborate with cross-functional teams to ensure quality integration in all processes. Train and mentor team members on QMS requirements and best practices. Qualifications Bachelor’s/Master’s in Engineering, Mechanical or related field. 7+ years’ experience in Quality Assurance, with 3+ yea...

What you will do: Develop and execute validation strategies and plans for new and existing computerized systems. Create and maintain validation documents including: User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessments; Validation Plans (VP); IQ/OQ/PQ Protocols and Reports; Traceability Matrix Ensure compliance with FDA regulations, EMA guidelines, and GAMP 5 standards. Collaborate with IT, Quality Assurance, Manufacturing, and other stakeholders to ensure system functionality meets business and regulatory needs. Perform impact assessments and change control activities for validated systems. Support data integrity initiatives and ensure systems comply with ...

Interested Candidate please share your resume to atull@harmanfinochem.com Job description Below are details for QC candidate to be recruited. Must have 3 to 6 yrs of experience in QC Should handle HPLC / GC instrument. M.Sc or B.Sc with experience also preferred. Should have worked in GLP /GMP environment Must have experience in API QC Shall have knowledge of 21 CFR / CSV / data integrity / validations Shall have knowledge of Method validation / Method transfer

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, workflows, and u...

Role & responsibilities: Candidates must have experience in plant maintenance with good knowledge of equipments like FBD, FBP, RMG, Blender, Compression Machine, Bulk Line, Blister & Cartonator, knowledge related to SAP. Candidate should have proper knowledge of PLC, SCADA, 21 CFR & QMS activities. Qualification: B.E./Diploma Experience: 3 to 8 Years Designation: Executive ***********************NOTE*********************** CANDIDATES SHOULD HAVE EXPERIENCE IN OSD ONLY. CANDIDATES HAVING EXPERIENCE IN API/PARENTERAL/NON - PHARMA WILL NOT BE CONSIDERED.

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...

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)

About The Role Project Role Software Development Lead Project Role Description Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills Veeva Vault Good to have skills NA Minimum 5 year(s) of experience is required Educational Qualification 15 years full time education Summary We are seeking a highly experienced and strategic Veeva Vault Clinical Development Lead to manage, lead, and deliver Veeva Vault-based solutions for clinical operations. The ideal candidate will have 10+ years of IT experience with signi...

About The Role Project Role Software Development Lead Project Role Description Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills Veeva Vault Good to have skills NA Minimum 5 year(s) of experience is required Educational Qualification 15 years full time education Summary We are seeking a highly experienced and strategic Veeva Vault Clinical Development Lead to manage, lead, and deliver Veeva Vault-based solutions for clinical operations. The ideal candidate will have 5+ years of IT experience with signif...

Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strat...

The opportunity Were looking for Senior Manager with expertise in Life Sciences Regulatory Compliance and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Client Responsibilities Participate and lead Regulatory Compliance engagements Help manage the financial aspects of engagements by organizing staffing, tracking fees, and communicating issues to project leaders Drive-in business development initiatives along with client management and account management Build strong internal relationships within...

Responsibilities: Analytical Operations: Perform and supervise analysis of Raw Materials (RM), Packing Materials (PM), and Finished Goods (FG). Operate and maintain analytical instruments :- HPLC, GC, UV-Vis, FTIR, Dissolution Apparatus Ensure compliance with GLP, 21 CFR Part 11, and data integrity standards. Review and approve analytical reports and LIMS entries , Quality Systems & Compliance Implement and monitor Quality Management Systems (QMS). Lead investigations for OOS, OOT, Deviations, and Laboratory Incidents. Prepare and review SOPs, STPs, and validation protocols. Ensure audit readiness and support regulatory inspections (USFDA, WHO-GMP, etc.) Documentation & Reporting Maintain ac...

What you will do In this vital role You will play a key role in a content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative demonstrates state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content. Role Description: We are seeking an Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Data Hub platform. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation pr...

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for quali...

What you will do As an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, an...

Role & responsibilities Support on IT quality systems framework design and implementation Managing the reviews and assessments for IT quality Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies GxP Business process review Development of integrated GxP and IT compliance Standard operating procedures and guidelines GxP and IT compliance assessment Define the Validation strategy of IT Software and Systems Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverable...

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

SUMMARY Senior iOS Developer Build Mission-Critical Health-Tech Apps (On-site only) Company: Ajmera Infotech Private Limited (AIPL) Location: Ahmedabad, Bangalore/Bengaluru, Hyderabad (On-site) Experience: 4 8 years Position Type: Full-time, Permanent Shape Mobile Experiences That Save Lives AIPL’s 120-engineer team powers planet-scale systems for global innovators. We are assembling a specialised iOS squad to build FDA-compliant, SwiftUI -first apps for a billion-dollar health-tech platform (client name confidential). Your code will run on iPhones and iPads used daily by clinicians and patients worldwide software that simply cannot fail. What Makes This Role Exciting Greenfield + Legacy mod...

Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications....

Purpose of the role: The Design Lead 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...

Job Title: Senior Executive – R&D Quality, CMC QA (Analytical) Business Unit: Global Quality & Compliance Job Grade G11B Location : Gurugram At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Rev...