45 Validation Protocols Jobs - Page 2

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...

Role & responsibilities Develop, execute, and document qualification protocols (DQ/IQ/OQ/PQ) for equipment, utilities, and facilities. Collaborate with Engineering, Production, QA, Or other Cross functional teams to coordinate qualification activities. Maintain qualification documentation, including risk/impact assessments and change-control records. Ensure compliance with USFDA, MHRA, WHOGMP, and ICH Q9/Q10 standards. Support internal and external audits and inspections focused on qualification. Diagnose deviations in qualification processes and initiate CAPAs. Manage and update the Qualification Master Plan and requalification schedules. Specialize in injectable product qualification (medi...

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products that cater to the needs of underserved patients. With a focus on delivering unique, accessible, and high-quality medications, Azurity utilizes its integrated capabilities and extensive partner network to continuously broaden its diverse commercial product portfolio and robust late-stage pipeline. The company's patient-centric products encompass various therapeutic areas such as cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. For more information, please visit www.azurity.com. Azurit...

As a Production Manager, you will be responsible for overseeing and managing day-to-day production operations to ensure quality, cost efficiency, and on-time delivery of products. You will develop and implement production schedules while ensuring compliance with Good Manufacturing Practices (GMP) and USFDA regulations. Your role will involve maintaining regulatory compliance with USFDA, WHO, and other standards, coordinating with the Quality Assurance (QA) team for audits, and ensuring proper documentation of manufacturing processes. Leading and mentoring the production team will be a key aspect of your job to drive optimal performance and regulatory awareness. You will be expected to foster...

ABOUT THE ROLE Role Description: We seek a skilled Sr. Associate Validation Analyst to oversee and manage validation activities for AI platforms and solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the AI products follow the required validation processes, documentation, and comply with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles Responsibilities: Plan, coordinate, and lead the execution of validation and change control activities, including ...

What you will do Role Description: We are seeking a highly skilled Validation Engineer to join our team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Develop and maintain Validation Plans, including scope, responsibilities, deliverables, and timelines. Perform ri...

Description We are seeking a highly skilled and experienced V&V Vehicle System Test Lead Engineer to join our team in India. In this role, you will be responsible for leading the verification and validation activities for AD/ADAS technologies, ensuring the highest standards of quality and performance in our vehicle systems. Responsibilities Lead the verification and validation (V&V) activities for vehicle systems focusing on Advanced Driver Assistance Systems (ADAS) and Automated Driving (AD). Develop and execute test plans, procedures, and reports for both hardware and software components of vehicle systems. Collaborate with cross-functional teams including software developers, hardware eng...