53 Validation Protocols Jobs

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...

Date: 15 Sept 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Development Services Job Title: Sterile Manufacturing, Filling Supervisor Department: Formulation production Job Location: Bengaluru, India About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. M...

As a skilled Battery Management System (BMS) Engineer, your role will involve having a solid understanding of BMS architecture, components, and safety features. Your experience in failure analysis, problem-solving, and Li-Ion battery assembly (including cylindrical, pouch, and prismatic cells) will be crucial. Additionally, expertise in LV and HV battery system handling will be required for this position. **Key Responsibilities:** - Design, develop, and test embedded software and firmware for BMS applications. - Integrate and configure BMS hardware, including microcontrollers, sensors, and communication interfaces (CAN, UART, SPI, I2C). - Implement state-of-charge (SOC), state-of-health (SOH...

Job Role : Manager / Sr.Manager (CMO) Location : Mumbai Job Summary : To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities requirements are met and that allCMOs achieve, maintain and improve the adequate level of compliance, through Quality Oversight for USA Markets. Key responsibilities: Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs). Should have experience in managing manufacturing operations at External contract manufacturing sites. Lead, oversee, approve & monitor Quality Management System (QMS) elements reported by CMOs, including change control, deviations, incidents, out of Specification (OOS)/ou...

Skills: GMP Compliance, CAPA Management, Validation Protocols, QMS, Quality Auditing, Standard Operating Procedures, Job Title: Head Quality Assurance (QA) Location: Indore- Company: Instrumentation & Control Solutions Experience: 5+ years in Pharma QA Job Type: Full-Time Job Description We are hiring a QA Head to lead and manage Quality Assurance activities in our pharmaceutical unit. The ideal candidate will ensure compliance with cGMP, regulatory standards (WHO-GMP, USFDA, EU, etc.) and internal QMS protocols. Key Responsibilities Lead QA operations including documentation, audits, and compliance. Handle deviations, CAPA, OOS investigations, and regulatory audits. Oversee SOPs, validation...

Job Summary: You will be responsible for overseeing and managing the validation processes of systems, processes, or products to ensure compliance with industry standards and regulations. Your role will involve extensive experience in system validation, quality assurance, and compliance management, with a focus on meeting regulatory requirements and ensuring operational efficiency. Key Responsibilities: - Lead and manage system validation activities for projects to ensure compliance with relevant regulatory standards such as FDA, GMP, ISO, and 21 CFR Part 11. - Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for systems and processes. - Coordinate with cross-function...

Job Title Manager - 1 (Production-Sterile) Business Unit Sun Global Operations Job Grade G10 Location : Dewas SGO 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 To ensure contamination control are availa...

As an analytical scientist in the Analytical Development department at Azurity Pharmaceuticals, you will be an integral part of the team responsible for developing new analytical methods for novel dosage forms to ensure product quality. Key Responsibilities: - Develop analytical methods primarily for sterile and oral dosage forms. - Prepare method development reports, validation protocols, test methods, and execute Analytical ATR. - Perform routine analytical testing for assigned projects and communicate findings to the formulation development team. - Calibrate equipment, qualify working standards, and maintain standards based on storage conditions. - Conduct forced degradation studies, iden...

As a Process Engineer, you will be responsible for supporting basic and detailed engineering design in process industries. Your role will involve 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. You will engage in technical discussions with stakeholders, clients, and consultants, offering technical input throughout the project lifecycle. Key Responsibilities: - Perform process calculations including line sizing, pump hydraulics, heat exchangers, and selection of control valves/PRVs/PSVs. - Develop and review PFDs, P&IDs, datasheets, and technical specificati...