20 Validation Protocols Jobs

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 be part of your responsibilities. Your principal accountabilities will include ensuring compliance with customer requirements, adhering to product and process quality check sheet guidelines, managing non-conforming products, raising pre-alerts in case of microbial risks, generating timely reports, and communicating relevant information to concerned parties. Safe disposal practices will also be a crucial aspect of your role. As a part of the job, you will need to collaborate with various teams across functions to achieve common goals. With a minimum of 2 years of experience, you are expected to demonstrate expertise in Entrepreneurship, Business & Commercial acumen, Global Mind-set, and People Excellence. Effective communication, attention to detail, and the ability to work in a dynamic environment will be key to success in this role. This position offers an opportunity to work in a fast-paced environment with a focus on quality control and testing activities. If you are someone who is detail-oriented, proactive, and passionate about ensuring product quality and safety, we encourage you to apply for this role at Welspun World.,

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 method validation protocols/reports, and execute bacterial endotoxin testing/review analytical data and related documentation. Your responsibilities will include trending microbiological results in terms of microbial monitoring of clean rooms/purified water results, equipment qualification/requalification within the Microbiology Lab, and reviewing PRPs and CCPs as per relevant procedures. Key Skills required for this role include validation, microbiology, testing, analytical data review, validation protocols, SOP preparation, microbial monitoring, good laboratory practices, and analysis reports.,

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 such as Commissioning, Site Piping, Installation & Qualification, Validation Protocols (SAT, IQ/OQ), Process Validation, and Equipment Validation. You will also be involved in risk management, compliance testing, functional and performance testing, as well as documentation and change control processes. Your responsibilities will extend to ensuring regulatory compliance with bodies such as FDA, EMA, and adherence to industry standards like ASME BPE Code, EU Guidelines for C&Q, and other relevant regulations. You will be involved in the 4 Stages of Equipment Qualification, CSV of System, Audit Trail, CIP/SIP, and Sterile Industry/Formulation practices. As part of your daily tasks, you will be carrying out Installation & Qualification, Equipment Qualification, Process Validation, OQ & CSV (Computer System Validation). You will also be involved in preparing Change Control Management, NCR (Non-Conformance Report), Documentation & Reporting, and Site Schedule (IQ & OQ). To excel in this role, you should have a Graduation/Post Graduation degree in Engineering, Biotechnology, or Chemical with 4 to 6 years of relevant experience. Your ability to coordinate effectively, manage site activities, and ensure compliance with regulatory requirements will be crucial for success in this position.,

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 accounts through consultative, solution-driven filtration systems. - Identify and convert new business opportunities in API, formulation, sterile injectables, and biotech segments. - Engage with decision-makers including Plant Heads, QA/Validation Teams, Utility Heads, and Engineering Managers. - Lead technical discussions on DQ/IQ/OQ/PQ, filter integrity testing, and documentation support. - Maintain an active sales pipeline, ensure timely follow-ups, and contribute to revenue growth. - Collaborate with internal product and application teams to develop customer-centric solutions. - Participate in technical presentations, trade shows, plant audits, and industry events. Must-Have Skills & Experience: - 3-8 years of sales or business development experience in filtration, CIP/WFI utility systems, or sterile process solutions. - Proven ability to close deals with pharma clients and strong knowledge of process filtration. - Comfortable with validation protocols (DQ/IQ/OQ/PQ), documentation cycles, and cleanroom compliance. - Excellent client-facing, presentation, and negotiation skills. - Willingness to travel frequently (domestic and occasional international). - A Bachelor's degree in engineering or pharmaceuticals is preferred. If you have the relevant experience and skills in technical sales of filtration systems for the pharmaceutical industry, we encourage you to apply for this exciting opportunity. Please note that only shortlisted candidates will be contacted. Thank you for your interest in this position.,

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 assay. Academic projects end to end delivery which involves liaising with sales, lab, sequencing, and bioinformatics team and the client. Reviewing literature for developing molecular including NGS based methods for detection of microbes in clinical specimens. Analysing molecular data, interpreting results, and generating test reports. Preparing SOPs and validation protocols. Supporting the sales and customer service team for technical queries as an when required Presenting experimental results to senior scientific staff, collaborators, and clients. Participating in technical decisions affecting research and development issues. Trouble shooting, investigating alternatives, and recommending possible courses of action. Maintaining knowledge of scientific technological developments by reading the current literature to develop innovative concepts. Keep the customers informed about delays if there is a library or data failure, after discussing with the supervisor. Constantly coordinating with the bioinformatics to ensure timely delivery of analysis results. Always be on the lookout for ways of improving lab processes, getting good data, cost cutting by altering lab processes, automation to reduce TATs etc. Development and validation of NGS based tests for detection of microbes in various clinical specimens. Performing and validation of RT-PCR based assay as and when required for detection of various microbes. Supervising pre-analytical, analytical, and post-analytical parameters of the assays Maintenance of specimen and DNA/RNA inventory. Supervise the lab team to manage turnaround times on a day-to-day basis. Ensure work does not stop in the lab due to lack of any reagents, manage stock requirements and liase with the purchase department to see to that enough reagent stock is always maintained. Discuss the clinical report with clinicians. Collaborate and direct research associate staff in a team-oriented structure to achieve project-specific timelines. Responsible for upkeep of the laboratory and always maintaining lab safety. Supervising the team and daily reporting to the supervisor Following CAP and NABL requirements in the lab and ensuring the team following the requirements. Supporting the quality assurance team during the audits. Regularly attend QAD meetings and ensuring all data are furnished in these meeting as per requirements. Training the new joiners. Educational Qualification: Phd in Microbiology If you are interested in this position, please click the APPLY NOW button for immediate employment consideration. We regret that due to volume of response, we can only contact initial successful applicants. If you have not heard from us within 7 days, then your application has been unsuccessful. Show more Show less

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 innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Result Areas Role-specific Provide input to Downstream for improvement of products/process. Develop and train high potential candidates for the next generation of leaders. Serve as a mentor to develop other leaders within the department. Downstream batch plan preparation as per campaign schedule. Supervise commissioning and qualification activity of BMP1 DSP related equipment. Preparation of micro batch schedule and shift planning for day-to-day activities. Monitor and follow good aseptic behavior inside the BMP1 facility. Support in audit and audit closure points. Involve in shipment of samples / final product as per packing and dispatch record. Preparation of BMRs, SOPs,IOPs & EOPs,general validation protocols and reports, equipment requalification protocols, Installation, operation and performance qualification protocols and related documents. Supervise Downstream activities of buffers preparation, Harvest, purification and final filtration, Calibration of operations equipment. Monitoring and process control of specific operations of downstream. Compliance to current good manufacturing practices. Preparation and periodic revision of equipment cleaning checklist (ECC)as ad when required. Perform room owner responsibility for the assigned DSP area. Maintain facility and assigned zone all-time ready for visit and audit. Involve in Shipment of samples /final product as per packing and dispatch record. Review of executed Documents on time. Education and Experience Education Graduate or Masters degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field. Industry Experience Minimum 10 - 15 years of relevant practical experience in Downstream process Production for biopharmaceuticals, specifically with CHO cell lines for monoclonal antibodies, fusion proteins, etc. Other Competencies Required For The Role NA Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Pls visit us at https://syngeneintl.com/ to know more about us and what we do. Show more Show less

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 focused on procedural documentation. Proficiency in tools such as Microsoft Word, Confluence, Excel, Visio, and document management platforms is essential. You should also possess a strong understanding of structured writing, information architecture, and documentation standards, as well as experience in servicing industries. Desired qualifications include a strong knowledge of commercial loan servicing terminology, validation protocols, and quality assurance documentation. You should also have the ability to analyze metrics and feedback to improve documentation usability, along with knowledge of digital documentation platforms and online help systems. This is a standard shift role with working hours from 7.30 am to 4.30 pm in Bengaluru and 8.30 am to 5.30 pm in Hyderabad, with flexibility required during projects. Trimont is committed to being an equal opportunity employer that values and supports diversity in the workplace. If you require accommodation or assistance during the application process due to a disability, please reach out to us. Additionally, Trimont maintains a drug-free policy to ensure a secure and productive environment for all team members.,

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, SPEC, formats, and checklists. Additionally, you will manage Control Sample and Stability Management, implement QA systems for compliance with SOPs, and handle both external and internal audits. You will review, evaluate, and approve documents on behalf of the factory department under the guidance of the technical head. As part of your responsibilities, you are expected to adhere to cGMP practices and ensure the proper implementation of recorded information. Furthermore, you will review and approve equipment qualification/requalification/validation protocols and compile summary reports of the products. If you are interested in this position, please send your application to pharmahr@bjainpharma.com.,

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 control over moisture and temperature levels. As part of your role, you will be monitoring the physiological and morphological characteristics of microorganisms and accurately identifying them. This position is full-time, and the work location is in person. Benefits include provided food and health insurance, and the working schedule is during the day shift. There is also a performance bonus offered. For more details about this opportunity, please contact +91 9947640555.,

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 will be essential to ensure optimal performance and awareness of regulatory requirements. You will foster a culture of continuous improvement, accountability, and teamwork among the team members. Identifying and implementing process optimizations to improve productivity, efficiency, and quality will be part of your responsibilities. Collaboration with cross-functional teams such as R&D, Quality Control (QC), and Supply Chain to resolve production-related issues is crucial. Additionally, you will be accountable for maintaining and calibrating production equipment and facilities, implementing safety protocols, managing inventory of raw materials, and preparing and managing the production budget to optimize costs without compromising quality. To qualify for this role, you should hold a Bachelors or Masters degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related field. A minimum of 5-7 years of experience in pharmaceutical manufacturing in a managerial role is required, along with proven experience in a USFDA-regulated environment. Knowledge of cGMP, CAPA, and regulatory submissions is essential. Your technical and functional skills should include a strong understanding of pharmaceutical production processes, familiarity with validation protocols, exceptional leadership, communication, and interpersonal skills, strong analytical and problem-solving abilities, and the ability to work under pressure and meet tight deadlines.,

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 Testing (UAT), test data preparation, and developing work instructions. Moreover, you will be responsible for developing and executing automated test suites across various modules in 3DEXPERIENCE, collaborating with cross-functional teams, and staying updated on new technologies and industry best practices to improve validation efficiencies. Additionally, you will work closely with the product teams and Dassault to pursue issue resolution. Basic Qualifications: - Bachelors degree and 2 to 6 years of experience in Software Quality and GMP Validation Preferred Qualifications: - Experience in Quality Assurance (QA) testing with at least 3 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions - Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.) - Overall experience in developing, executing, and analyzing QA & Test Automation - Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation - Experience with computer system validation and software validation - Strong problem-solving and analytical skills Soft Skills: - Excellent analytical and troubleshooting skills - Strong verbal and written communication skills - Ability to work effectively with global, virtual teams - High degree of initiative and self-motivation - Ability to manage multiple priorities successfully - Team-oriented, with a focus on achieving team goals - Ability to learn quickly, be organized and detail-oriented - Strong presentation and public speaking skills At Amgen, we are committed to developing treatments that take care of others while also supporting your professional and personal growth and well-being. We offer competitive benefits and a collaborative culture to support your journey every step of the way. In addition to the base salary, Amgen provides competitive and comprehensive Total Rewards Plans aligned with local industry standards. Join us now and make a lasting impact with the Amgen team. Apply at careers.amgen.com.,

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 internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits. Maintaining documentation for batch release, validation protocols, and quality systems, ensuring adherence to data integrity and good documentation practices (GDP), and supporting qualification and validation activities are crucial aspects of this position. Collaboration with cross-functional teams such as Production, QC, and R&D is essential for ensuring smooth operations. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift with additional perks such as performance bonus and yearly bonus. The work location is in person.,

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 ensuring proper documentation of all manufacturing processes as per USFDA requirements. Your role will also involve Team Leadership, where you will lead, mentor, and train the production team to ensure optimal performance and awareness of regulatory requirements. You will be responsible for fostering a culture of continuous improvement, accountability, and teamwork among the team members. Process Improvement will be another key aspect of your role, where you will identify and implement process optimizations to enhance productivity, efficiency, and quality. Collaboration with cross-functional teams such as R&D, Quality Control (QC), and Supply Chain will be essential in resolving production-related issues. In terms of Equipment and Facility Management, you will need to ensure the proper maintenance and calibration of production equipment and facilities, as well as implement safety protocols to maintain a hazard-free work environment. Resource Planning will also be part of your responsibilities, as you manage the inventory of raw materials to ensure uninterrupted production. You will be required to prepare and manage the production budget to optimize costs without compromising quality. To qualify for this role, you should hold a Bachelors or Masters degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related field, along with a minimum of 5-7 years of experience in pharmaceutical manufacturing in a managerial role. Proven experience working in a USFDA-regulated environment, with knowledge of cGMP, CAPA, and regulatory submissions, is essential. You should possess a strong understanding of pharmaceutical production processes, including tablet, capsule, injectable, or API manufacturing, as well as familiarity with validation protocols such as IQ, OQ, and PQ processes. Exceptional leadership, communication, and interpersonal skills, along with strong analytical, problem-solving, and decision-making abilities, will be crucial for success in this role. Additionally, the ability to work under pressure and meet tight deadlines will be necessary to excel in this position.,

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. Collaboration with internal teams including QA, IT, SAP, business users, and L2 integrations, as well as external vendors and infrastructure leads, will be a key aspect of this role. Your responsibilities will encompass stakeholder management, managing project timelines, risks, and dependencies, ensuring infrastructure readiness, facilitating change management, and maintaining compliance with site validation and quality standards. As the single point of contact for MES implementation at the site, you will play a critical role in driving collaboration and successful deployment. It is crucial to ensure adherence to global regulations such as FDA 21 CFR Part 11, EU GMP, GAMP5. Previous experience with Werum (Korber Pharma) for the pharma industry is highly desirable. Your main areas of responsibility will include: - Project Coordination: Leading and coordinating all MES implementation activities at the site to ensure alignment with the global MES strategy. - Stakeholder Management: Serving as the single point of contact for site-level stakeholders, including QA, QA IT, IT, SAP, and business users (Production & Engineering). - Vendor & Partner Collaboration: Working closely with MES vendors, infrastructure teams, and integration partners to ensure smooth execution. - Timeline & Risk Management: Managing project schedules, tracking milestones, identifying risks, and implementing mitigation plans. - Infrastructure & Readiness: Ensuring site infrastructure (network, servers, systems) is ready and validated for MES deployment. - Compliance & Validation: Overseeing adherence to site quality standards, IT validation (CSV), and regulatory requirements. - Communication & Reporting: Maintaining clear and timely communication with the Global Project Manager and other stakeholders; providing regular updates and escalating issues as needed. - Change Management: Facilitating change control processes and supporting user readiness and adoption. To qualify for this role, you should hold a Bachelor's degree in Engineering, Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. A Master's degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Project Management, Operations Management, Industrial Automation, or Pharmaceutical Technology is preferred. Specific certifications such as PMP for structured project execution and GAMP5 or CSV Training for compliance in regulated environments are advantageous. Ideally, you should have 9 to 10 years of experience managing IT or digital transformation projects, preferably in pharmaceutical manufacturing. Hands-on experience with MES platforms, L2/PLC systems, and SAP integration and Edge Cloud IoT is required. A proven track record in project planning, stakeholder coordination, and cross-functional team leadership is essential. Strong background in GxP compliance, CSV, and validation protocols (IQ/OQ/PQ) is crucial, along with experience working on the shop floor and with QA, IT, and business teams in a regulated environment. Your functional and behavioral skills should include strong project management expertise in IT/digital systems, knowledge of MES platforms, L2/PLC systems, and SAP integration, familiarity with GxP, CSV, and validation protocols, understanding of pharmaceutical manufacturing processes and shop floor operations, proficiency in stakeholder coordination and cross-functional collaboration, strong communication and interpersonal skills, proactive problem-solving and risk management, high attention to detail and compliance mindset, ability to work under pressure and manage multiple priorities, and a team-oriented approach with a focus on collaboration and accountability. Additional skills such as knowledge of data analytics tools, Edge Cloud deployment experience with IoT and IIoT, L2 integration with MES, MES integration with SAP, and understanding of network and databases would be beneficial for this role.,

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 (media fill, aseptic simulation, smoke studies). Oversee qualification of systems such as water, steam, HVAC, filling/sealing machines, autoclaves, isolators, washing tunnels/DHS units, and more Preferred candidate profile Deep knowledge of qualification and validation best practices (equipment, utilities, facilities) and Hands-on experience with media fill/aseptic simulation, smoke studies, and utilities (water, steam, HVAC). Proficient in URS/DQ/IQ/OQ/PQ processes for various equipment (vial/ampoule washers, filling/sealing units, autoclaves, isolators). Strong understanding of equipment qualification, utility validation, and cleanroom classification. Familiarity with cGMP, data integrity (ALCOA+), and GxP documentation standards. Competent in creating/reviewing technical documentation and qualification protocols in line with regulatory requirements. Excellent analytical and problem-solving skills, with a methodical attention to detail. Proven ability to collaborate cross-functionally and interface confidently during audits and inspections.

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. Azurity Pharmaceuticals takes pride in fostering an inclusive workplace environment and is committed to being an Equal Opportunity Employer. The success of Azurity is attributed to its exceptionally talented and dedicated team, which is driven by the mission of enhancing patients" lives through a combination of cutting-edge science and unwavering commitment to quality. We are looking for individuals who are highly motivated, possess integrity, and embody a creative spirit to excel in our organization. The Analytical Development department within the science organization at Azurity Pharmaceuticals plays a crucial role in developing new analytical methods for novel dosage forms to ensure product quality. Responsibilities: - Develop analytical methods for product development, primarily focusing on sterile dosage forms and/or oral dosage forms. - Prepare method development reports, validation protocols and reports, as well as test methods. - Perform routine analytical testing for assigned projects according to requirements. - Execute Analytical ATR (Analytical Testing Reports), document results, and communicate findings to the relevant formulation development (FD) team. - Calibrate assigned equipment, qualify working standards, and maintain standards based on storage conditions. - Conduct forced degradation studies and identify unknown impurities. - Conduct experiments to address and respond to regulatory queries. Qualifications And Education Requirements: - 6-8 years of experience in Analytical Development of Formulation. - M. Pharm or MSc in Chemistry. By applying for this role, you confirm that you possess the mental and physical capabilities necessary to fulfill the job responsibilities outlined in the job description without any restrictions. If you have any concerns or disabilities that may impact your ability to perform the job, please inform HR in advance.,

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 a culture of continuous improvement, accountability, and teamwork. Identifying and implementing process optimizations to enhance productivity, efficiency, and quality will be essential. Collaboration with cross-functional teams such as R&D, Quality Control (QC), and Supply Chain will be required to address production-related issues effectively. In terms of equipment and facility management, you will need to ensure proper maintenance and calibration of production equipment and facilities. Implementing safety protocols to uphold a hazard-free work environment is crucial. Resource planning will also be part of your responsibilities, involving managing raw material inventory and maintaining uninterrupted production. You will also be tasked with preparing and managing the production budget to optimize costs without compromising quality. For this role, a Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related field is required. A minimum of 5-7 years of experience in pharmaceutical manufacturing in a managerial capacity is necessary, along with a proven track record in USFDA-regulated environments and knowledge of cGMP, CAPA, and regulatory submissions. Your technical skills should include a strong understanding of pharmaceutical production processes, familiarity with validation protocols, exceptional leadership and communication skills, as well as strong analytical and problem-solving abilities. The ability to work under pressure, meet tight deadlines, and collaborate effectively with various teams will be critical to your success in this role.,

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 qualification and validation of AI products and platforms. Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Functional Skills: Must-Have Skills: 5 or more years of experience in validation in a GXP-regulated environment (pharmaceutical, biotech, medical devices, etc. ). Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Education and Professional Certifications Master s degree and 2 years of Information Systems experience, OR Bachelor s degree and 4 years of Information Systems experience Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. .

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 risk-based assessments to determine the level of validation required. Assist in defining User Requirements and Functional Requirements. Draft and review various validation artifacts. Ensure all documents are compliant with 21 CFR Part 11, Annex 11, and other relevant regulations. Coordinate and/or execute validation protocols. Support change management processes for validated systems. Ensure continuous validation throughout the system lifecycle (including periodic reviews). Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time. Stay updated with the latest trends and technologies, and related fields. Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently. Basic Qualifications: Masters degree and 1 to 3 years of experience in Computer Science, IT or related field experience OR Bachelors degree and 3 to 5 years of experience in Computer Science, IT or related field experience OR Diploma and 7 to 9 years of experience in Computer Science, IT or related field experience Must-Have Skills: Strong technical background, including understanding software development processes, databases, and cloud-based systems. Experience implementing CSA guidance. Experience with product backlog management (e.g., Jira) and collaboration tools. Preferred Qualifications: Basic understanding of Veeva Quality Vault. Strong Analysis skills with basic Veeva configuration knowledge. Excellent communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and problem-solving skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills.

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 engineers, and system architects to ensure seamless integration of AD/ADAS technologies. Identify and mitigate risks associated with V&V processes while ensuring compliance with industry standards and regulations. Analyze test results, diagnose issues, and provide actionable insights to improve system performance and reliability. Mentor junior engineers and provide guidance on best practices in V&V processes for vehicle systems. Skills and Qualifications Bachelor's or Master's degree in Engineering (Electrical, Electronics, Mechanical, or a related field). 7-12 years of experience in V&V, testing, or related roles within the automotive industry, specifically with AD/ADAS technologies. Strong understanding of vehicle systems architecture and AD/ADAS functionalities. Proficient in using testing tools and simulation environments (e.g., MATLAB, Simulink, CANoe, etc.). Experience in developing automated testing frameworks and methodologies for vehicle systems. Knowledge of automotive standards and regulations (ISO 26262, ASPICE, etc.) is a plus. Excellent analytical and problem-solving skills with a keen attention to detail.