360 Validation Jobs - Page 11

Job Description: A day in the life of an Infoscion As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domains vendor evaluation information etc and build POCs You will create requirement specifications from the business needs define the to be processes and detailed functional designs based on requirements You will support configuring solution requirements on the products understand if any issues diagnose the root cause of such issues seek clarifications and then identify and shortlist solution alternatives You will also contribute to unit level and organizational initiatives with an objective of providing high quality value adding solutions to customers If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Key Responsibilities: Minimum 1 years of experience in Oracle Fusion HCM modules like Global HR Payroll Absence Benefits Compensation Talent Succession Planning Performance Management Profile Management Recruiting ELM Security in this case since requirement is for Payroll experience in Payroll and Security is a must Should have Knowledge of DFF Fusion Fast Formula Should be aware of Oracle Fusion HCM Co Existence and working on the same Must have experience in BI OTBI Reports Must be experienced in Development Configuration solutions evaluation Validation and deployment Should have high level familiarity of Oracle Fusion HCM Payroll tables Technical Requirements: Ability to work with clients to identify business challenges and contribute to client deliverables by refining analyzing and structuring relevant data Awareness of latest technologies and trends Logical thinking and problem solving skills along with an ability to collaborate Ability to assess the current processes identify improvement areas and suggest the technology solutions One or two industry domain knowledge Preferred Skills: Technology->Oracle Cloud->HCM Cloud Technical

Key Responsibilities: A day in the life of an Infoscion As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domains vendor evaluation information etc and build POCs You will create requirement specifications from the business needs define the to be processes and detailed functional designs based on requirements You will support configuring solution requirements on the products understand if any issues diagnose the root cause of such issues seek clarifications and then identify and shortlist solution alternatives You will also contribute to unit level and organizational initiatives with an objective of providing high quality value adding solutions to customers If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Technical Requirements: Minimum 2 years of experience in Oracle Fusion HCM modules like Global HR Payroll Absence Benefits Compensation Talent Succession Planning Performance Management Profile Management Recruiting ELM Security in this case since requirement is for Payroll experience in Payroll and Security is a must Should have Knowledge of DFF Fusion Fast Formula Should be aware of Oracle Fusion HCM Co Existence and working on the same Must have experience in BI OTBI Reports Must be experienced in Development Configuration solutions evaluation Validation and deployment Should have high level familiarity of Oracle Fusion HCM Payroll tables Additional Responsibilities: Ability to work with clients to identify business challenges and contribute to client deliverables by refining analyzing and structuring relevant data Awareness of latest technologies and trends Logical thinking and problem solving skills along with an ability to collaborate Ability to assess the current processes identify improvement areas and suggest the technology solutions One or two industry domain knowledge Preferred Skills: Technology->Oracle Cloud->HCM Cloud Technical

Job Title: QA Assistant / Executive - API Industry Location: Kakinada, AP Company: Lyfius Pharma About Lyfius Pharma is 100% subsidiary of Aurobindo Pharma. Its largest API Unit of Aurobindo. Lyfius spread across 236 acres in Kakinada SEZ and it is second largest API manufacturing facility in ASIA. Qualification: M Sc / B Sc/ B Pharm Experience: 2 to 10 Years Job responsibilities: Quality Management System QMS Handling & Responsible for: Change Control, Deviation, Out of Specification, Market Complaint, Corrective and Preventive Action (CAPA) Annual Product Quality Review. Audit Compliance Report Preparation. Document Controller All document Issue, Review & Retrieval COA preparation BMR & BPR Preparation & Review Specification, Method of Analysis & Protocol & Report preparation for Finished product, Intermediate product, In-process, Raw material, Packing material. Standard Operating Procedure (SOP) Preparation Site Master Plan & Validation Master Plan Preparation Technical Data Package (Tech Pack), Formula Master Preparation. All Declaration Preparation for regulatory submission, Customer Free Sample, Vendor Sample and Customer Query Related work. Policies & system procedures preparation. External Manufacturing & Toller documentation Control & Follow-up. Training Calendar preparation and control. Qualification / Calibration / Validation Responsible for all Calibration activity Internal & External and maintained the record. Responsible for Equipment Qualification & Documentation control Vendor Qualification and regular follow up for updated documentation by the supplier, Process Validation Protocol & Report Preparation Cleaning Validation Protocol & Report Preparation Analytical Method Validation Protocol & Report Preparation IPQA Issue and control of SOPs, BMRs, BPRs, BCRs and also finished product label/product container seals /sealing of the containers as the part of IPQA activities. Review BMRs, BCRs and analysis records before release of API. Perform sampling of APIs, maintain its records and ensure the cleaning of sampling tools. Provide line clearance at the time of product changes over. Perform the documentation control activity at site. Monitor/Maintain/Review of Records and Handling of controlled/Retained samples of Intermediates/Finished API.

Job Summary: Maimsd Technology is seeking a highly skilled Senior Software Engineer with expertise in both Java and Python . The ideal candidate will have significant experience in manufacturing test platform development and will be crucial in defining, developing, and executing pre-silicon and post-silicon factory test infrastructure for Datacenter GPUs. This role requires strong collaboration skills across hardware, firmware, software, and data center infrastructure teams to ensure comprehensive validation and optimize manufacturing processes. Key Responsibilities: Platform Test Infrastructure Development: Define, develop, and execute the Datacenter GPU pre-silicon and post-silicon factory test infrastructure . Develop comprehensive platform validation plans and flows, ensuring end-to-end coverage. Develop and implement robust debug strategies to efficiently resolve system-level issues. Cross-functional Collaboration & Design: Collaborate across multiple disciplines (hardware, firmware, software, and/or data center infrastructure) on design requirements and risks. Participate actively in design reviews and proof-of-concept projects. Assess system tradeoffs and their impact on performance, identifying dependencies for validation and manufacturing tests. Validation & Optimization: Through comprehensive lab work, test new designs to verify compliance to specifications. Work with AMD (or relevant internal) cross-functional teams and Contract Manufacturing to drive early-stage process development, DFX (Design for Excellence) reviews, and manufacturing optimization. Required Skills: Programming Languages: Experience developing solutions utilizing both Java and Python . Manufacturing Test Platforms: Industry experience in manufacturing test platform development . DevOps & Version Control: Experience with source code control and build pipelines like Jenkins and GitHub Actions . Agile Methodologies: Experience working on a team utilizing agile development practices. Qualifications: Education: Bachelor's or Master's degree (preferred) in Computer Science, Computer Engineering, Electrical Engineering, or equivalent. Experience Level: Minimum 5 years of experience in platform validation that includes SW/FW (Software/Firmware) and test development.

Company Overview BOLD is an established and fast-growing product company that transforms work lives. Since 2005,weve helped more than 10,000,000 folks from all over America(and beyond!) reach higher and do better. A career at BOLD promises great challenges, opportunities, culture and the environment. With our headquarters in Puerto Rico and offices in San Francisco and India, were a global organization on a path to change the career industry Key Responsibilities •Work with Business Analysts, BI Developers to translate Business requirements into Test Cases •Responsible for validating the data sources, extraction of data, applying transformation logic, and loading the data in the target tables. •Designing, documenting and executing test plans, test harness, test scenarios/scripts & testcases for manual, automated & bug tracking tools. Required Skills •Experience in Data Warehousing / BI Testing, using any ETL and Reporting Tool •Extensive experience in writing and troubleshooting SQL Queries using any of the Databases Snowflake/ Redshift / SQL Server / Oracle •Exposure to Data Warehousing and Dimensional Modelling Concepts •Experience in understanding of ETL Source to Target Mapping Document •Experience in testing the code on any of the ETL Tools •Experience in Validating the Dashboards / Reports on any of the Reporting tools Sisense /Tableau / SAP Business Objects / MicroStrategy •Hands-on experience and strong understanding of Software Development Life Cycle (SDLC)and Software Testing Life Cycle (STLC). •Good experience of Quality Assurance methodologies like Waterfall, V-Model, Agile, Scrum. •Well versed with writing detailed test cases for functional & non-functional requirements. •Experience on different types of testing that includes Black Box testing, Smoke testing, Functional testing, System Integration testing, End-to-End Testing, Regression testing & User Acceptance testing (UAT) & Involved in Load Testing, Performance Testing & Stress Testing. •Expertise in using TFS / JIRA / Excel for writing the Test Cases and tracking the •Exposure in scripting languages like Python to create automated Test Scripts or Automated tools like Query Surge will be an added advantage •An effective communicator with strong analytical abilities combined with skills to plan, implement & presentation of projects

To support development,validation & optimization of powertrain systems including IEC,hybrid powertrains & EV drivetrains. Conducting lab & vehicle-level tests, analyzing performance data, ensuring systems meet regulatory and performance standards.

Roles and Responsibilities Conduct equipment qualification, validation, and vendor qualification activities according to established procedures. Perform process validation protocols, reports preparation, and CAPA implementation as required. Ensure compliance with regulatory requirements by maintaining accurate records of documentation and data analysis. Collaborate with cross-functional teams to identify areas for improvement in validation processes. Develop and execute test plans for new equipment installations or modifications.

We have an urgent opening for Mechanical Design Engineer position with our esteemed client manufacturing automobile parts MNC at Pune (Khed) location. Interested candidates mail your updated resume at unihr02@gmail.com 5 Days Working Subsidized company bus (Nashik Phata to Khed route) Subsidized canteen facility for lunch Qualification - Engineering graduate Experience - 3 to 6 Years Job Responsibilities Engineer MECHANICAL DESIGN ENGINEERING: 1) Work under the HOD’s instruction on design trade-offs are involved with other systems, under instructions and in collaboration with HQ R&D in Italy 2) As Design Engineering engineer you are expected to coordinate design, development, and enhancement of new and existing products/product lines 3) You will ensure to work under the direction of the manager to meet project milestones and completes projects within the established timeline. Additionally, you will need to escalate issues, provide resolution, and communicate to your manager both in Pune and in Italy. 4) You will work with team of design engineers and assist in providing input to strategic decisions that affect the functional area of responsibility 5) You are expected to resolve escalated issues arising from operations and requiring coordination with other departments

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Job Opening: Technical Recruiter (3+ Years Experience) Location:- Bangalore (WFO) Notice Period:- Only Immediate Joiners preferred Were looking for dynamic Technical Recruiters with a minimum of 3+ years of experience in technical hiring to join our growing team. Key Requirements: Proven experience in end-to-end technical recruitment across various roles and domains Strong background working in corporate or high-growth environments Demonstrated ability to source, assess, and close top-tier tech talent Excellent communication and stakeholder management skills Willingness to work from the office

Core Purpose of the Role: Responsible to perform the development, validation, and routine testing of bioassay/ELISA for Large Molecules (LMs), especially Monoclonal antibodies (mAbs) and other LMs Role Accountabilities: Shall develop and validate cell-based assays and binding assays (ELISA), especially for monoclonal antibodies (mAbs), etc. Shall troubleshoot the problems with bioassay methods Must have strong knowledge of the development of cell-based bioassays for Monoclonal antibodies. Experience in Qualification and Validation of cell-based bioassays Broad knowledge on analysis of cell-based assays to derive relative potency softwares (such as Softmax Pro and PLA) Basic cell culture technics and hands-on experience in maintaining of mammalian cells. Must have experience in handling various cell lines (adherent and suspension cell lines). Preparation of Mammalian cell banks for Bioassays. Experience in handling of primary and continuous cell lines like Revival, maintenance, cell bank preparation, and cryopreservation Shall prepare the raw datasheets, protocols, reports, and SOPs Handling of QMS (Incidents, deviations, change controls, etc.) for GMP activities Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares etc., required for the projects Shall adhere to the procedure of GxP/GMP/Safety and as per the procedure defined in the internal standard operation procedure Must have good hold on MS office (word, excel, ppt), outlook, and other essential tools required for routine activity Good communication and e-mail writing skills are required since the candidate needs t communicate with clients/external users situated overseas Commitment to safety

Role & responsibilities Lead end-to-end recruitment processes, including sourcing, screening, interviewing, and onboarding candidates. Understand the position/mandate able to understand the roles and responsibilities and identify the right resource for the same using various sources, referrals etc. Develop and implement effective sourcing strategies to attract candidates with niche engineering skills. Collaborate with hiring managers to understand their staffing needs and provide expert recruitment advice. Maintain a strong pipeline of qualified candidates through proactive sourcing and networking. Conduct thorough candidate screening and provide recommendations to hiring managers. Ensure a positive candidate experience throughout the recruitment process. Stay updated on industry trends and best practices in recruitment. Preferred candidate profile Ideal Candidate: - Bachelors degree in Human Resources, Business Administration, or a related field. Minimum of 5 to 7 years of experience in recruitment, with a focus on niche engineering skills., Should have good experience dealing with recruitment pertaining to Engineering Products, Pumps, Industrial Valves, Actuators Proven experience in end-to-end recruitment processes. Expertise in sourcing strategies and techniques. Experience in the industrial or advanced manufacturing sector. Proficiency in English reading, writing, and speaking. Should be able to communicate to the Global team on a regular basis. Should have ample experience working in Consulting / Recruitment Firms – should have dealt in mid-level, senior level positions related to Valves, Pumps, Actuators, Excellent communication and interpersonal skills. Should be willing to work from Bangalore location (Office) Knowledge in recruiting for IT positions will be an added advantage. Proven experience in an agency setting is mandatory.

Key Requirements: MCAL DriverExpertise:Strong Experiencewith 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.

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation AR&D Department . Job Openings: 3 Nos Position : Research Analyst or Sr Research Analyst Experience : 3 - 8 Yrs Job Description: Responsible for Analytical Method Development activities solid orals and injectables Responsible for Responsible for Planning and Monitoring of Method development activities and Regular Analysis for solid orals and Injectables. Responsible for Routine and Stability analysis activities for solid orals and injectables. Responsible for the Review of documents generated in Method development activity. Responsible for the Preparation and Review of Tentative method of analysis and Method development Reports. Responsible for the review of Routine samples documents, Preformulations documents for the Solid oral products and Parental products. Responsible for the Review of Calibrations documents (i.e Dissolution, HPLC, UV and balance). Knowledge on ICH guidelines and all Regulatory guidelines. Responsible for XRD - FARD Experience. Please Share me Update Resume :Careers@biophore.com Total Exp: Current CTC: Exp CTC: Notice Period: Designation:

Role & responsibilities Conduct inspection and testing of incoming raw materials, reagents, and components used in IVD product manufacturing. Review CoA, CoC, MSDS, and other supplier documents and ensure compliance with specifications. • Maintain and update incoming inspection records, logs, and release documents. Coordinate with vendors for material discrepancies, rejections, and corrective actions. Ensure that all materials are tested as per SOPs, QMS guidelines, and regulatory standards. Participate in vendor audits and provide inputs for supplier qualification. Collaborate with cross-functional teams including procurement, production, and R&D for material-related issues. Support in non-conformance investigation and initiate CAPA for recurring issues. Ensure calibration and maintenance of IQC instruments and equipment. Adhere to ISO 13485:2016, Good Documentation Practices (GDP), and applicable regulatory requirements. Regards, Muskan Vats muskan.v@head2hire.com

Job Role : Manager Validation Location : Mohali Responsibilities : Build a cohesive Team to support Validation activity in A- 41 Mohali Location Collaborate for creating a robust CAPA program Equipment and facility Validation of A- 41 Mohali Location, along with site Specific teams, which includes preparation, review and execution of protocols, and Master Validation documents. Preparation, Review and execute protocols & reports in facility involving utilities, engineering, manufacturing operation & cleaning which shall include but not limited to HVAC, water, compressed air, process/packing equipment w.r.t. qualification & validation To ensure that all qualification and validation protocols include critical steps / components which are to be checked and validated To prepare, review & ensure compliance & written procedure w.r.t. validation function To co-ordinate, review and manage the training needs and records as a department training coordinator (DTC). To prepare validation planner for all utilities and equipments To ensure the implementation of current good manufacturing practices To look after the maintenance & improvement of product quality as per specification To provide the training to personnel involved in validation activities as & when required Participate in Quality Improvement projects To ensure that all systems and equipments are validated as per the procedure/ requirements and calendar Responsible for Quality Management System compliance i.e., Handling of Deviation, Investigation, CAPA and CCR Responsible to perform the internal and external audit as per the site specific procedure. Any other responsibility that may be assigned from time to time Education Qualification : B.Pharm / M.Pharm Experience : 12 to 15 Yrs (in Validation / Qualification)

Team manager with good leadership skills Design, configuration, integration and implementation of process control solutions for various industries Develop P&IDs and loop descriptions for various plants, processes, and/or equipment. Develop User Requirement Specifications. Develop software and hardware design specifications. Design, program, implement, test and document process control applications. Develop control system validation/testing protocols. Specify and purchase Siemens/Rockwell components, drives, and other electrical components and equipment. Develop electrical panel schematics. Manage automation projects as assigned. Monitor progress of projects. Install, test, and start-up control systems on-site Required Candidate profile A Bachelors degree in Electrical / Electronics / Instrumentation / Computer Science Engineering or equivalent combination of education and technical experience. A minimum of five (6) years of experience in either a consulting engineering firm or operating engineering environment. Thorough knowledge of process instrumentation and control systems. Knowledge of and familiarity with the National Electric Code (NEC) and international standards. Experience designing and programming control systems with emphasis on Siemens or Rockwell controls. Experience in commissioning and startup of control systems is required. Ability to work with plant engineers, external vendors, operators and management to manage projects and assignments is essential. Ability to troubleshoot control systems from the field element up through operator interfaces and databases. Experience with control system networking technologies and PC networking technology. Experience working with SQL Server, Oracle, or other relational databases. Any experience with Visual Basic scripting is a big plus. Excellent written and verbal communication skills. Strong interpersonal skills and the ability to work in a team environment. Ability to work effectively in a fast paced multi-tasking environment. Experience in biotech/pharma, water, wastewater, medical device, or the food industry is required. Experience with PLC, HMI, and SCADA systems is a plus Specific knowledge of cGMPs and batch process control in the life science industry with validation experience is a plus. Knowledge of 21 CFR Part 11 requirements is a plus.

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.