45 Validation Protocols Jobs

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...

Role Overview: You will be responsible for ensuring the timely and compliant review of CMC documentation, Method Development/Validation Protocols & Reports, Stability Protocols & Reports, Instrument/Equipment Qualification records, and BMR. You will also be involved in compiling high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various sites, liaising with third party contract manufacturers, and recommending actions for continuous improvement in product quality. Additionally, you will participate in Quality Management Systems, Performance Management, Training, and provide miscellaneous support as needed. Key Responsibilities: - Review CM...

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same. Job Description Your Role As a DeltaV Engineer, you will be responsible for designing, implementing, and supporting automation solutions using Emerson's DeltaV Distributed Control System (DCS). ...

Job Description As the Head of Quality Assurance at Instrumentation & Control Solutions in Indore, you will be responsible for leading and managing all Quality Assurance activities within the pharmaceutical unit. Your primary focus will be to ensure compliance with cGMP, regulatory standards such as WHO-GMP, USFDA, EU, and internal Quality Management System (QMS) protocols. Key Responsibilities - Lead QA operations, overseeing documentation, audits, and ensuring compliance. - Manage deviations, Corrective and Preventive Actions (CAPA), Out of Specification (OOS) investigations, and regulatory audits. - Supervise Standard Operating Procedures (SOPs), validations, and training programs. - Ensu...

As a Plant IT Pharma (GxP Compliance) in Bangalore within the Information Technology / Manufacturing IT department, you will have the following key responsibilities: - Manage all IT operations at the manufacturing plant, ensuring alignment with corporate IT standards and regulatory requirements. - Provide GxP-compliant support for manufacturing systems (MES, LIMS, SCADA, etc.) and ensure proper documentation and validation protocols are followed. - Act as the primary IT contact for plant and quality assurance teams. - Support audits and inspections by regulatory bodies (FDA, EMA, etc.) by providing required documentation and demonstrating compliance. - Manage local infrastructure (servers, n...

As a Senior Scientist - Microbiology at MedGenome Labs Ltd. in Bengaluru, you will be an integral part of our dynamic team dedicated to clinical genomics. With over 8 years of experience in Microbiology, NGS, and RT PCR based assays, you will play a crucial role in developing molecular methods for the detection of microbes in clinical specimens. Your responsibilities will include analyzing molecular data, interpreting results, and generating test reports. Additionally, you will be expected to prepare SOPs, validation protocols, and present experimental results to senior scientific staff, collaborators, and clients. Key Responsibilities: - Review literature to develop molecular methods for de...

We are looking for a meticulous Asst. Manager Production to lead production activities at Synnat Pharma Private Limited, ensuring seamless API manufacturing operations and adherence to the highest quality standards. As Asst. Manager Production, you will play a pivotal role in overseeing daily production activities, monitoring validation batches, and ensuring compliance with cGMP guidelines. Your responsibilities will include the preparation and review of production-related documents, coordination with cross-functional teams, and active participation in internal and external audits. You will also be responsible for identifying and resolving operational gaps, managing deviations and Out-of-Spe...

Job Summary: As a Validation Compliance GxP Consultant, you will be responsible for overseeing and managing the validation processes of systems, processes, or products to ensure compliance with industry standards and regulations. You should have extensive experience in system validation, quality assurance, and compliance management, with a focus on meeting regulatory requirements and operational efficiency. Key Responsibilities: You will lead and manage system validation activities for projects to comply with regulatory standards such as FDA, GMP, ISO, and 21 CFR Part 11. Developing and executing validation plans, protocols (IQ, OQ, PQ), and reports for systems and processes is a key part of...

The ideal candidate for this position would be a Masters Graduate with hands-on experience in Microbiology, capable of working independently. You will be responsible for tasks such as media preparation, maintaining incubation conditions, storage, and creating Validation Protocols. You must also have proficiency in using microscopic instruments and possess strong Laboratory Skills. Your duties will include supervising and conducting research on various microbiological activities regularly. It is essential to stay updated on different research methods and perform manual operations on various supplies effectively. You will need to develop and uphold validation protocols for environmental contro...