61 Validation Protocols Jobs

Donaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make meaningful contributions at work and in communities. Key Responsibilities : Leading projects for engineering changes in existing Air/Liquid/Hydraulic filtration products through CQP or Engineering Change Orders (ECOs). Carrying out all project management activities from change initiation to implementation for various types of engineering changes...

As a Manufacturing Process Support Lead, you will be responsible for various tasks including but not limited to: - Leading the upstream manufacturing process support, data acquisition, and trending. - Managing statistical analysis of manufacturing batches data using statistical software like Minitab, etc. - Leading the upstream team in troubleshooting and process related deviation investigations activities to identify the root cause followed by providing an effective CAPA. - Planning, evaluating and managing the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing). - Collaborating and communicating regularly with R&D teams in execution of e...

Role Overview: As a Quality Control Analyst II at Teva Pharmaceuticals, you will be responsible for performing Stability analysis, Method transfer, Method Validation, and reviewing analytical documents. Your main tasks will include preparation and review of Method Transfer Protocols (MTP), Method transfer report (MTR), Method of analysis (MTH), Standard Testing Procedure, Test Data Sheet (TDS) for Stability Analysis, Method transfer and Method Validation, Stability Summary Reports, and any document related to stability analysis, method transfer, and method validation in compliance with current guidelines. Additionally, you will be involved in the review and maintenance of all logbooks of the...

Role Overview: As a SBAPL_Team Member QC Testing at Welspun World, your primary responsibility will be to supervise and perform tests on various microbiological activities regularly. You will also be required to maintain knowledge on different testing methods, develop and maintain validation protocols for environmental controls, perform laboratory analysis on materials post sterilization, conduct tests on component samples, identify contamination sources, perform culture of micro-organisms, and monitor their characteristics. Key Responsibilities: - Ensure compliance as per customer's requirement - Adhere to product and process Quality check sheet - Control non-conforming products as per proc...

As a Regulatory and Quality Manager at our company in Noida, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining high product quality standards. Your responsibilities will include: - Implementing the Quality Management System in accordance with regulatory guidelines. - Managing regulatory documentation to ensure accuracy and completeness. - Overseeing the Continual Improvement of Systems and Product Quality Review Process for the Corrective and Preventive Action System. - Ensuring data integrity and implementing Standard Operating Procedures (SOP) and policies. - Evaluating and approving master documents across various departments. - Preparing and...

As a Commission & Qualify professional, your role involves conforming Systems, Equipment, and Plants to pre-approved Site Acceptance Test (SAT) Protocols at the Customer's Site. You will be accountable and responsible for the following key activities: - Coordinate with clients for SAT activities, plans, and execution. - Coordinate with the team to resolve site/service issues and provide necessary guidance. - Review site activities according to the given schedule and escalate if there are delays. - Manage site costs and drive continuous improvement processes. - Manage the team, including resource planning, appraisal, training, and grievance handling. - Carry out Commissioning, Site Piping, In...

As a member of the Analytical Development department at Azurity Pharmaceuticals, you will play a crucial role in developing new analytical methods for novel dosage forms to ensure product quality. Responsibilities: - Develop analytical methods, primarily focusing on sterile and/or oral dosage forms. - Prepare method development reports, validation protocols, test methods. - Perform routine analytical testing for assigned projects. - Execute Analytical Testing Reports, document results, and communicate findings to the formulation development team. - Calibrate equipment, qualify working standards, and maintain standards based on storage conditions. - Conduct forced degradation studies, identif...

As a Process Engineer, you will be responsible for supporting basic and detailed engineering design in process industries. Your role will include preparing heat/mass balances, equipment sizing/selection, PFDs, P&IDs, BOMs, and datasheets. Additionally, you will coordinate with vendors, control costs, and provide on-site support. Engaging in technical discussions with stakeholders, clients, and consultants and offering technical input throughout the project lifecycle will also be part of your responsibilities. Key Responsibilities: - Perform process calculations such as line sizing, pump hydraulics, heat exchangers, and control valve/PRV/PSV selection. - Develop and review PFDs, P&IDs, datash...

Zydus Lifesciences is Hiring! Virtual Walk-In Interviews for IT CSV Role 4th Dec 2025 We are looking for talented IT CSV Engineers to join our IT team across multiple manufacturing sites based at Ahmedabad. Interview Details: Date: Thursday, 4th December 2025 Time: 09:30 AM 02:00 PM Location: Virtual (Microsoft Teams) How to Apply: Apply to this job post (mandatory) Candidates needs to apply for the job latest by 03rd December 2025. Based on applications, shortlisted candidates will receive an email with the Microsoft Teams link to join the virtual interview. Designation: Executive / Assistant Manager Department: IT Role: Site CSV (Computer System Validation) Location: Ahmedabad Experience: ...

Key Job Responsibilities: Preparation & Execution of Qualification documents for Machinery / Systems / Equipment’s. Preparation & Execution of Computer System Validation documents for Machinery / Systems / Equipment’s. Preparation & Execution of Performance Qualification documents for Machinery / Systems / Equipment’s. Preparation and review of DQ/FS/FAT/IQ/OQ/Operational Manuals for In-house machinery. Compilation and review of Raw data, MOC and Test certificates. Responsible for co-ordination with user department for daily activities. Coordinate with customer / In-house team to carry out Qualification and Documentation activities. Responsible for review of GA, P& ID and Electrical drawings...

As an Engineer I in Electrical & Electronics Engineering IX, you will be responsible for designing, selecting components, creating electrical drawings, testing, and validating new products related to Power Electronics, UPS Systems, Static Switches, and Power Distribution Units (PDU). Your role will involve working on the design-to-deployment lifecycle, utilizing strong problem-solving skills, and collaborating with cross-functional teams. Key Responsibilities: - Design, analyze, and validate electrical systems for UPS, Static Switches, and PDUs. - Select suitable electrical components ensuring cost-effectiveness, reliability, and compliance with standards. - Prepare and review schematic diag...

About the Role We are seeking an MBBS doctor who is interested in technology, AI, and product development, rather than conventional hospital practice. This role involves working closely with the tech and product teams to develop, refine, and validate AI-driven medical tools for the US healthcare sector. You will serve as the medical expert behind the tool, helping to define requirements, reviewing outputs, and ensuring clinical quality and safety. Key Responsibilities Understand US healthcare workflows and guidelines relevant to the product. Work with product managers to translate clinical logic into requirements/rules/flows for the AI tool. Review AI outputs for accuracy, safety, and releva...

Skills: GxP Compliance, 21 CFR Part 11, Risk Assessment, Validation Protocols, Computerized System Validation (CSV), Validation, GAMP, Were Hiring! CSV Validation Engineer - Mandideep/Goa/Baddi /Nashik/Nagpur/Digwal(Hyderabad )/Dabasa/ Vizag /Indore Pan India Position: CSV Validation Engineer Company: INSTRUMENTATION AND CONTROL SOLUTIONS (ICS) Location: Mandideep/Goa/Baddi /Nashik/Nagpur/Digwal(Hyderabad )/Dabasa/Indore /Vizag / Pan India Experience: 1 to 5 Years Notice Period: Immediate to 30 Days preferred Key Responsibilities & Skills Preparation & execution of Validation Deliverables as per GAMP5 and 21 CFR Part 11 guidelines Hands-on experience with GAMP, 21 CFR Part 11, GxP, IQ/OQ/PQ,...

Skills: GxP Compliance, 21 CFR Part 11, Risk Assessment, Validation Protocols, Computerized System Validation (CSV), Validation, GAMP, Were Hiring! CSV Validation Engineer - Mandideep/Goa/Baddi /Nashik/Nagpur/Digwal(Hyderabad )/Dabasa/ Vizag /Indore Pan India Position: CSV Validation Engineer Company: INSTRUMENTATION AND CONTROL SOLUTIONS (ICS) Location: Mandideep/Goa/Baddi /Nashik/Nagpur/Digwal(Hyderabad )/Dabasa/Indore /Vizag / Pan India Experience: 1 to 5 Years Notice Period: Immediate to 30 Days preferred Key Responsibilities & Skills Preparation & execution of Validation Deliverables as per GAMP5 and 21 CFR Part 11 guidelines Hands-on experience with GAMP, 21 CFR Part 11, GxP, IQ/OQ/PQ,...

Skills: GxP Compliance, 21 CFR Part 11, Risk Assessment, Validation Protocols, Computerized System Validation (CSV), Validation, GAMP, Were Hiring! CSV Validation Engineer - Mandideep/Goa/Baddi /Nashik/Nagpur/Digwal(Hyderabad )/Dabasa/ Vizag /Indore Pan India Position: CSV Validation Engineer Company: INSTRUMENTATION AND CONTROL SOLUTIONS (ICS) Location: Mandideep/Goa/Baddi /Nashik/Nagpur/Digwal(Hyderabad )/Dabasa/Indore /Vizag / Pan India Experience: 1 to 5 Years Notice Period: Immediate to 30 Days preferred Key Responsibilities & Skills Preparation & execution of Validation Deliverables as per GAMP5 and 21 CFR Part 11 guidelines Hands-on experience with GAMP, 21 CFR Part 11, GxP, IQ/OQ/PQ,...

Description We are seeking a detail-oriented QC Executive to join our team in India. The successful candidate will be responsible for ensuring that our products meet the required quality standards through rigorous testing and inspections. Responsibilities Conduct quality control inspections and tests on products to ensure compliance with specifications and standards. Document quality control procedures and results, and maintain accurate records of inspections and tests. Collaborate with production and engineering teams to identify and resolve quality issues. Assist in the development and implementation of quality control policies and procedures. Participate in internal and external audits re...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description The API EM TS/MS person-in-plant (PIP) mfg. scientist provides leadership and functional-area expertise at the designated C...

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,?collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.?Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. Job Description The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk as...

As a skilled individual in the Microbiology department, you will be responsible for various tasks related to media preparation, incubation conditions, storage, and validation protocols. Your key responsibilities will include: - Performing media preparation and ensuring proper incubation conditions, storage, and assessment with expiry dates, consumption, and accountability. - Supervising and conducting research on various microbiological activities regularly. - Maintaining knowledge of research methods and performing manual operations on supplies. - Developing and maintaining validation protocols for environmental controls. - Conducting laboratory analysis on materials post sterilization. - D...

As a Production Supervisor, your role involves overseeing various aspects of production operations to ensure smooth functioning and adherence to quality standards. Your key responsibilities include: - Indenting, approving, and receiving batch production records, cleaning records, and packing records based on production requirements. - Raising raw material indents and approving indented raw materials in alignment with production planning. - Maintaining good housekeeping in the plant environment. - Coordinating with cross-functional teams to execute plant operations efficiently. - Monitoring equipment utilization and manpower distribution for optimal productivity. - Initiating, reviewing, and ...

As a CSV Expert at Lupin Limited, your role will involve ensuring the compliance and validation of computerized systems within the organization. Your responsibilities will include conducting risk assessments, developing validation protocols, executing validation tests, and maintaining thorough documentation. Additionally, you will collaborate with cross-functional teams to support system implementation and ensure adherence to regulatory requirements. Key Responsibilities: - Conduct risk assessments for computerized systems - Develop validation protocols for system validation - Execute validation tests and document results - Collaborate with cross-functional teams to support system implementa...

As a Microbiologist at our company, your role will involve the following responsibilities: - Reporting and reviewing microbiology results of Raw Materials, Packing Materials, In-process Materials, and Finished Products as required. - Reviewing and approving Microbiological analysis reports including Water, Microbial monitoring of clean rooms, MLT, and BET. - Preparation of SOPs related to QC Microbiology. - Maintaining media stock and related GPT records. - Implementing Good Microbiological Laboratory Practices at work. - Reviewing microbial test results of water samples as required. - Maintaining reference standard cultures / subcultures; preparation and maintenance of working cultures as a...

Job Title Manager - Plant Engineering, Pharma Formulations Plant Maintenance Pharma Formulations Basic & Minimum Qualification Degree in Mechanical Engineering from a reputed university . Experience 12 to 15 years of working experience in a Pharmaceutical Formulations plant. Location: Ankleshwar Site. Job Description And KEY ACCOUNTABILITIES Engineering & Maintenance Operations Oversee preventive, predictive, and breakdown maintenance of plant equipment and infrastructure. Ensure optimal performance of manufacturing & packing, and warehouse equipment. Lead root cause analysis and corrective actions for equipment failures. Documentation and maintaining the History cards of all critical plant ...

Title: Senior Executive - API Custom Field 2: 2752 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Ensuring that analytical methods are validated and verified in compliance with regulatory standards. Reviewing and approving validation protocols and reports to ensure accuracy and consistency. Reviewing and evaluating raw data from analytical testing to ensure compliance with specifications and standards. Identifying trends, deviations, and out-of-specification results in analytical data and recommending corrective actions. Ensuring that all analytical testing is performed according to SO...

Role & responsibilities 1. Drafting Documents: Prepare and update design documents (FS/DS/HDS/SDS), assessment documents (C/FRA/EMRA/ERES/EMRA, etc.), validation documents (FAT/SAT/IQ/OQ/PQ), and manual documents (OM/MM/SM) based on URS, task specifications, technical parameters, design drawings, and other relevant materials. Work closely with the Design and Validation departments to ensure document accuracy and technical compliance. 2. Revising Documents: Modify and update documents as needed based on customer review feedback. 3. Printing Documents: Ensure finalized documents are printed and delivered to the customer site in accordance with company procedures. 4. Regulatory Compliance: Fami...