67 21 Cfr Jobs - Page 2

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...

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...

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 ...

What you will do In this vital role You will play a key role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages 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: In this vital role as Senior Manager Information Systems, you will lead a dynamic team of technical product owners, business analysts, developers, test/validation engineers, project managers and scrum masters responsible for the ongoing ...

Job Role: CQV Engineer Experience: 2-4 years Location: Bengaluru Key Responsibilities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WHO) Should have sound knowledge in good documentation Pr...

We are seeking an experienced Validation Engineer to join our team supporting a GxP platform that automates regulatory filings. This role is key to ensuring compliance, driving efficiency, and fostering innovation in data validation processes. You will collaborate closely with developers, business analysts, and stakeholders to validate technical requirements and support continuous improvements and automation within the program. Key Roles & Responsibilities Develop detailed test plans and validation strategies aligned with project specifications and regulatory requirements. Execute manual and automated testing including functional, regression, and performance tests. Document and report defect...

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)

Role & responsibilities 1. Preparation of Qualification documents for Pharmaceutical OSD Process Equipments. - URS, DQ, IQ, OQ, PQ 2. Execution of IQ, OQ & PQ of Process Equipments 3. Execution of modification projects 4. Review of Process Equipments layouts & associated utilities 5. Review of Process Equipment Vendor PFDs & PIDs 6. Preparation of URS for Process Equipment’s 7. Preparation of QRA & CR for modification projects 8. Creation of Maintenance plan, Calibration plan for Process equipment’s 9. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 10. Completion of all trainings assigned to role 11. Ensure integrity of data at workplace. 12. Ensure Good Do...

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (I...