38 Validation Protocols Jobs

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...

The role of SBAPL_Team Member QC Testing at Welspun World involves supervising and conducting tests related to various microbiological activities regularly. You will be responsible for maintaining knowledge of different testing methods, performing manual operations on various supplies, and establishing validation protocols for environmental controls. Additionally, you will be required to conduct laboratory analysis on materials post sterilization, test component samples for contamination, and analyze sources of contamination to implement corrective actions. Culturing micro-organisms in isolation, monitoring their characteristics, and ensuring control over moisture and temperature will also b...

You will be responsible for reporting and reviewing microbiology results of Raw Materials, Packing Materials, In-process Materials, and Finished Products as necessary. Additionally, you will review and approve Microbiological analysis reports including Water, Microbial monitoring of clean rooms, MLT, and BET. Your role will involve preparing SOPs related to QC Microbiology, maintaining media stock and related GPT records, and implementing Good Microbiological Laboratory Practices. You will also review microbial test results of water samples and maintain reference standard cultures/subcultures. Furthermore, you will be expected to prepare miscellaneous validation protocols/reports, MLT & BET ...

As a Commission & Qualify professional, you will be responsible for ensuring that systems, equipment, and plants comply with pre-approved Site Acceptance Test (SAT) Protocols at the customer's site. Your primary role will involve coordinating with clients for SAT activities, creating and executing SAT plans, and resolving any site issues that may arise. Additionally, you will be expected to review site activities based on schedules, manage site costs effectively, and drive continuous improvement processes. In this role, you will play a key part in team management, including resource planning, performance appraisals, training, and grievance handling. Your expertise will be utilized in areas s...

As a Sales Leader/Manager in the Pharma Filtration industry, you will be responsible for driving B2B/OEM sales of validated filtration products to pharmaceutical API/formulation and biotech plants. Your role will involve managing and growing key accounts, identifying and converting new business opportunities, and engaging with decision-makers across different segments. You will lead technical discussions, maintain an active sales pipeline, and collaborate with internal teams to tailor customer-centric solutions. Key Responsibilities: - Drive B2B/OEM sales of validated filtration products such as depth filters, membrane cartridges, and process housings. - Manage and grow key pharma/biotech ac...

Find your next role with MedGenome Labs Ltd. We are the market leader in clinical genomic space in India and offers a comprehensive range of diagnostic services to doctors and researchers. We operate the largest CAP accredited Next Generation Sequencing (NGS) lab in Southeast Asia housing cutting-edge genome sequencing platforms. MedGenome is the founding member of GenomeAsia 100K, an initiative to sequence 100,000 Genomes in Asia. We have an exciting opportunity for the position of Senior Scientist - Microbiology in Bengaluru location. It is a full time and work from office opportunity. Skills and Experience Required: 8+ years of experience working in Microbiology, NGS and RT PCR based assa...

Date: 12 Aug 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Manufacturing Services Designation: Assistant Manager Job Location: Bangalore Reporting to: Deputy Manager Job Grade: 8-II The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovati...

As an Associate Director Technical Writer at Trimont, you will play a key role in creating and maintaining clear, accurate, and compliant procedural documentation to support operational excellence. Your responsibilities will include writing and updating technical procedures, SOPs, and work instructions for operations teams. You will collaborate with engineers, Subject Matter Experts (SMEs), and compliance teams to ensure that all documentation meets internal standards and external regulatory requirements. To excel in this role, you should have a Bachelor's degree in English, Communications, Business, Finance, or a related field, along with 3 to 5 years of experience in technical writing focu...