31 Validation Protocols Jobs

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...

The Regulatory and Quality Manager role in Noida requires a female candidate and involves various responsibilities related to quality management and regulatory compliance. You will be responsible for implementing the Quality Management System in alignment with regulatory requirements. This includes managing regulatory documentation and overseeing the Continual Improvement of Systems, Product Quality Review Process, Corrective and Preventive Action System. Your accountability extends to ensuring data integrity and implementing SOPs and policies. You will evaluate and approve master documents across different departments and prepare and approve various master documents such as BMR, SOP, STP, S...

You will be responsible for supervising and conducting research on various microbiological activities on a regular basis. This includes maintaining knowledge on different research methods and carrying out manual operations on supplies. You will also be required to develop and uphold validation in all protocols related to environmental controls. Your duties will involve performing laboratory analysis on materials post sterilization, conducting tests on component samples, identifying any contamination, analyzing the findings, and implementing corrective measures as necessary. Additionally, you will study cultures of microorganisms in isolation as per standard inhibition practices, ensuring con...

As a Production Manager, you will be responsible for overseeing and managing day-to-day production operations to meet quality, cost, and delivery targets. You will develop and implement production schedules to ensure timely product delivery while ensuring adherence to Good Manufacturing Practices (GMP) and compliance with USFDA regulations. Your role will involve maintaining and ensuring compliance with USFDA, WHO, and other regulatory standards in all production processes. You will coordinate with the Quality Assurance (QA) team to prepare for and manage regulatory audits, inspections, and proper documentation of manufacturing processes. Leading, mentoring, and training the production team ...

In this vital role, you will play a key part in ensuring quality and adherence to required standards so that the engineering teams can effectively build and deploy compliant products. You will be involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta in web applications. Your responsibilities will include developing and maintaining comprehensive test plans for 3DExperience platform modules and applications, contributing to release planning, estimating test efforts, analyzing and communicating test results in an Agile development environment, and developing validation documentation. You will also assist with User Acceptance Test...

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in ...

As a Production Manager, your primary responsibility is to oversee and manage day-to-day production operations to meet quality, cost, and delivery targets. You will be tasked with developing and implementing production schedules to ensure timely product delivery while ensuring adherence to Good Manufacturing Practices (GMP) and compliance with USFDA regulations. In terms of Regulatory Compliance, you will play a crucial role in maintaining and ensuring compliance with USFDA, WHO, and other regulatory standards throughout all production processes. This will involve coordinating with the Quality Assurance (QA) team to prepare for and manage regulatory audits and inspections, as well as ensurin...

We have an exciting opportunity for a Manager IT-MES & L2 project coordinator at our Halol/Baska(Gujarat) location. As a seasoned professional with 7-9 years of experience in the pharmaceutical industry, you will be responsible for overseeing Manufacturing Execution Systems (MES) and L2 integration. Your role as the Site Project coordinator for MES Implementation will involve coordinating all MES-related activities at the Halol / Baska sites. It is essential that you provide dedicated full-time support to the project to ensure smooth execution, alignment with the global MES strategy, and timely delivery of milestones to enhance manufacturing efficiency, compliance, and digital transformation...