107 Validation Jobs - Page 5

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and their timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW and Emerging markets Preferred candidate profile Key Skills: eCTD, CTD, Validation, ICH requirements, USFDA Filings, EMA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products. Must have exposure to in-licensed dossier filing and out licensing Candidates with 6+ years of relevant experience. Candidate must have experience on Bio pharma products

External Job Description Job title: Qualification & Validation Expert, Report Issuance Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Apply and align documentation standards with global quality team. Ensure that qualification reports and activities adhere to all applicable quality regulations and pharmaceutical practices. Validate that qualification activities meet health-related requirements, including safety and environmental standards. Review qualification protocols, reports, and documentation for accuracy, completeness, and compliance. Collaborate with cross-functional teams, including Quality Assurance, and Engineering, to ensure alignment and consistency in qualification practices. Provide training and support to team members on compliance-related topics and best practices. About you: Experience: >5 years professional experience in qualification Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments Technical skills: Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point Education: Bachelors degree in engineering, Pharmacy, Chemistry, or a related field. Advanced degree (e.g., MSc, PhD) preferred Languages: Excellent English communication and writing, French or other Languages in addition preferred.

Qualification & Validation Specialist, Report Issuance Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Include references to relevant documents essential for the qualification process. Finalize qualification protocols and reports by adjusting layout and format to meet organizational standards and regulatory requirements Communicate the approval of qualification protocols and updates to all relevant stakeholders via Content Management Systems (CMS), ensure timely dissemination of information and update. Schedule formal consolidated review and approval meetings for qualification protocols Launch and manage the review workflow in CMS, tracking progress and ensuring deadlines are met. Collaborate closely with the Global Qualification Team Lead, Expert, and Specialist to support qualification activities Ensure all documentation complies with overall documentation standards. Identify opportunities for process improvement in document management and workflow efficiency and implement enhancements to streamline qualification protocol finalization and communication processes About you: Experience: Professional experience in general documentation and project management. Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments. Technical skills: CMS, Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point. Education: Bachelors degree in business administration, life sciences, or a related field. Languages: Excellent English communication and writing, French or other Languages in addition preferred

Role & responsibilities Checking of SOP Compliance. Preparation and Updation of the Site Master File . Preparation and Updation of Validation Master Plan QA SOPs preparation/Revision. Execution of product Disposition/dispatch activity. Tracking of SOP revision due of all departments. Issuance, retrieval and destruction of SOP controlled copies. BMR, BCR issuance, retrieval and review. Line clearance after change over in production areas. Monitoring of routine manufacturing activities. Handling of Change Control. Handling of Deviations. Assist HOD QA for any technical information needed, documents requirement so as to carryout smooth and consistent day-to-day QA activities. Filling customer questionnaire. Feedback giving to marketing related queries. Participate in customer and regulatory audits. Performing vendor/supplier audits. Performing Internal audits. Review of validation & Qualification documents. Preparation of Annual Product Quality Report & updating online trend analysis. Vendor Qualification activity. PR requisition in oracle. Verifying batch no. correctness in oracle before issuance of batch manufacturing records. GMP rounds. Retained documents management. All documents issuance, retrieval and review. Label, Seals procurement, Issuance, Control and Inventory Management. Day-to-day Coordination with all departments. Controlled Copies Issuance related to all departments. Preferred candidate profile Post Graduate in M.Sc with 6 to 8 years or relevant industry experience. Should be able to handle independently. Thorough knowledge of SOP preparation, validation and audits.

Note * Please mention the required skill sets in your resume ,if you have the experience in the skills. Key Requirements: MCAL Driver Expertise : Strong Experience with drivers like MCU, PWM, GPT, WDG, ADC, DIO, PORT, MEM, SPI, UART, CDD; SWC Creation and Development; BSW Configuration DaVinci Configurator : Proficient in using DaVinci Configurator and Developer tools. Automation of DaVinci Configurator with Groovy Scripting. Good in Embedded C Programming SWS Documents: Strong understanding and implementation skills of MCAL. API & Configuration: Strong understanding of MCAL various APIs and configuration parameters.

In this role, you will: Lead or participate in moderate to high risk or complex review activities in a matrixed environment and communicate emerging risks to management within Independent Testing Contribute to large scale planning related to Independent Testing deliverables Review and research moderately complex potential corrective actions, and follow through on reporting, escalation, and resolution Ensure effective and appropriate testing, validation, and documentation of review activities for risk programs and controls according to standards and other applicable policies Resolve moderately complex issues and lead team to meet Independent Testing deliverables while leveraging solid understanding of risk management framework and the risk and control environment Collaborate and consult with colleagues, internal partners, management and lines of business regarding risk management Required Qualifications: 4+ years of Independent Testing experience, or equivalent demonstrated through one or a combination of the following: work experience, training, military experience, education Desired Qualifications: Strong Excel and Power point skills Should have good exposure in Compliance and Risk Job Expectations: Work timings would be 1:30 PM to 10:30 PM 11 May 2025 Wells Fargo maintains a drug free workplace. Please see our to learn more.

Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.