360 Validation Jobs - Page 12

HIRING FOR FORMULATION UNIT - INJECTABLE/ OSD JOB DESCRIPTION AND EXPERIENCE: WORK LOCATION: Hetero Labs Limited, UNIT V & VI, Polleypally, Jadcherla, Mahabubnagar PRODUCTION(OSD) Experience: (02-07Years) Compression, Granulation, Coating, Capsule filling, Inspection PRODUCTION (INJECTABLE) Experience: (02-07Years) Autoclave, Compounding, filling, QMS, Vial Washing, Lyophilizer, Visual Inspection PACKING (INJECTABLE/OSD) Experience: (01-05Years) Blister Packing, Bottle Packing. QC & QC- Micro Experience: (02-07Years) HPLC, GC, RM,PM, Stability, IP/FP,MLT, Environmental monitoring, QA-INJECTABLE Experience: (02-07Years) IPQA, Validation, Qualification, CSV, AQA (QC & Microbiology) WAREHOUSE Experience: (01-07Years) Raw Material, Packing Material, Finished Goods QUALIFICATION : I.T.I, Diploma, B.Com, B.Sc, B.Tech, B. Pharm, M.Sc with relevant experience DESIGNATIONS: Operator, Sr.Operator, Jr.Officer, Officer, Jr.Executive, Executive & Sr. Executive INTERVIEW VENUE: Hotel: UJWALA GRAND Gandimaisamma, gandimaisamma- Medak Road, Hyderabad, Telanagana- 500043 DATE &TIME: 28th & 29th June'2025 (Saturday & Sunday); From 09.00 A.M. to 03.00 P.M NEED TO CARRY: Resume, 3 Month Pay slips, Increment letter, Previous company relieving letters, Education Documents and ID Proofs Help Us Spread the Word (Refer): Circulate it in your Social Networking sites and groups for better reach and Refer your friends and colleagues, it could be a great opportunity for someone in need! CONTACT INFO: E-mail: Harishwar.m@hetero.com & Cont: 8121036004 for further info

Expertise and strong hands-on experience in transistor level analog design Experience and a proven track record of bringing your designs to production Understanding of device level operation & physics Knowledge of low power design in sub-40nm process OR High Voltage analog circuit design experience & knowledge of BCD/HV processes Good understanding of layout considerations for either high precision analog applications or high speed analog design in sub-40nm process nodes and ability to oversee the same Knowledge of System aspects such as Noise Figure, Phase Noise, IIP3, ACI, BER, PER, Spurious Analysis is desirable for RF positions Analog Design positions require design experience in any of the following analog blocks: Amplifiers/OPAMP circuits, ADCs/DACs, LDOs, Bandgaps & Bias Circuits, Temperature Sensor, Oscillators Senior Analog Design positions require the ability to architect and design analog signal chains for high precision analog applications. RF Design positions require experience in any of the following Analog design blocks: Low Noise Amplifier(LNA), Mixer, Charge Pump, Voltage Controlled Oscillator(VCO), Frequency Dividers, Power Amplifier etc; knowledge of Wireless Transceiver architectures and System trade-offs will be a plus Experience in analog/mixed-signal co-simulations & analog verification Experience in lab evaluation of initial silicon, programming and data analysis in C#, Python, and/or Matlab Strong analytical and problem-solving skills Strong written and verbal communication skills

Developing and executing test plans and procedures to verify the functionality and performance of a design Identifying and documenting design defects and issues, and working with designers and other stakeholders to address them Analyzing test results and data to identify patterns and trends, and making recommendations for design improvements Developing and implementing automated test scripts and test frameworks to improve testing efficiency and accuracy Collaborating with other engineers and stakeholders to ensure that all design requirements are properly verified and validated Creating and maintaining documentation related to the verification and validation process, including test plans, test reports, and traceability matrices Participating in design reviews and providing feedback on design requirements and testability Providing technical support and expertise to other departments, to ensure that designs are implemented correctly and meet all necessary requirements Strong analytical and problem-solving skills, with the ability to identify areas for improvement and develop effective solutions

Design of DC-DC High Frequency Switching Power Supplies using ADI s large portfolio of Power Management Integrated Circuits. New DC-DC Monolithic (Integrated Power and Controller) Power Products definition. Validation of the new generation Power Management Integrated Circuits. Full product life-cycle ownership - Definition, Validation and Market Introduction. Responsibilities include: Development of product evaluation kits and system reference design boards Circuit schematic design and PCB layout creation Performance optimization and characterization in application circuits Validate new products, creating new test methodologies. Data collection for datasheets and release notes Collate results with design and test engineers. Technical support to key customers and field engineers Simulation of Power Electronics Converters Minimum Requirements: Masters degree in Power Electronics At least 4+ years of hands-on experience in developing switching power supplies. Basic understanding of transistor-level analog circuit design Strong written and verbal communication skill

QMS Activities IPQA Activities Validation Activities Must be having experience in API Desired Profile: Designation : Officer / Executive/ Senior Executive Qualification : M.Sc. Chemistry/ B.Pharm/ M.Pharm Experience: 02 10 year

Job Title: SAP CO Platinum Consultant Experience: 1015 Years Job Locations: Hyderabad, Bangalore, Chennai, Pune, New Delhi, Mumbai Job Summary: We are seeking a highly experienced SAP CO Platinum Consultant to lead and manage greenfield S/4HANA implementation projects within the life sciences and pharmaceutical industry. The role involves designing and configuring SAP CO modules tailored to specific business needs and regulatory standards, ensuring smooth integration, testing, validation, and data migration. Key Responsibilities: Lead and manage greenfield S/4HANA implementation projects in life sciences/pharma. Design and configure SAP CO to meet business requirements and comply with regulations such as GMP. Oversee system integration, testing, validation, and data migration activities. Conduct client meetings to gather requirements, present solutions, and provide updates. Facilitate workshops to understand client challenges and deliver customized solutions. Build and maintain strong client relationships as the primary project contact. Develop innovative solutions aligned with client needs and industry regulations. Monitor project milestones to ensure timely delivery focused on industry-specific requirements. Required Qualifications & Skills: 10–15 years of experience in SAP CO with greenfield S/4HANA implementation expertise. Deep knowledge of SAP CO configuration, design, and integration. Experience in life sciences/pharmaceutical industries, understanding GMP and related regulations. Proven skills in client management and workshop facilitation. Excellent leadership, communication, and project management abilities. Strong problem-solving and innovation mindset.

Experience in pharma regulatory & QMS function, primarily in RLD / comparator sourcing, clinical trial supply chain management, and clinical packaging for USA and EU markets. The role includes supporting the end QMS function and regulatory affairs. Health insurance Provident fund Annual bonus

Opening in Medicamen Biotech Ltd(ANVISA & EU), Bhiwadi, Raj. Pharma formulation exp. Preferred Qualification: B.Sc./B.Pharma Vacant Post: 10 Nos. QA - IPQA/Documentation/Validation QC - IPQC/HPLC/Chemical Testing/GC/KF Mail-ID: hrd@medicamen.com Required Candidate profile Immediate joiner prefer Experience : 2 to 6 Years Ready to Relocate Bhiwadi Self Motivated/ Team Player/ Committed for Performance. E-Mail: hr-ho@medicamen.com Mob: +91 7240001632/ 9992395009

Role & responsibilities Validation & Qualification Oversight Prepare and maintain Validation Master Plans (VMP) in alignment with corporate and regulatory guidelines. Review and approve qualification documentation including URS, DQ, IQ, OQ, PQ, RQ , ensuring completeness and compliance. Supervise execution activities and guide the team during validation and qualification stages. Oversee and review Performance Qualification (PQ) , Requalification , interim and summary reports , and addenda . Documentation & SOP Management Develop and review validation protocols , SOPs, and QA documentation related to equipment, facility, and utility qualification. Review and ensure compliance of SOPs from other departments that impact validation and qualification processes. Ensure proper documentation control, including version management and approval routing. Project Management & Execution Ensure timely completion of validation activities in alignment with project milestones and regulatory timelines. Review layouts and engineering drawings for facilities, utilities, and equipment to ensure compliance and suitability for intended use. Maintain and oversee revalidation schedules in accordance with change control and periodic review programs. Deviation & Change Control Handling Investigate and document validation-related deviations and change controls , recommending and implementing appropriate corrective and preventive actions (CAPAs) . Collaborate with cross-functional teams to resolve validation and qualification issues proactively. Training & Team Development Mentor and train QA validation team members on current practices, regulatory expectations, and internal standards. Conduct knowledge-sharing sessions to build team capability in equipment, facility, and utility validation . Compliance & Continuous Improvement Ensure cGMP compliance in all validation and qualification activities, maintaining a validated state at all times. Continuously evaluate and improve validation systems, practices, and documentation to meet evolving regulatory requirements. Preferred candidate profile Bachelors or Master’s degree in Pharmacy with 8–12 years of relevant experience in QA Validation within a regulated injectable manufacturing facility . Proven expertise in equipment / facility / utility qualification , process validation , and cleaning validation . Strong knowledge of regulatory guidelines : cGMP, 21 CFR Part 11, EU Annex 1, WHO TRS, ICH Q8-Q10. Experience in deviation handling , change control , and validation risk assessments . Ability to read and interpret engineering drawings , layouts, and P&IDs. Hands-on experience with documentation systems and quality management systems (QMS).

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

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Interfaces with customers and vendors representing company as Quality champion. Formulates and maintains quality assurance objectives complementary to corporate policies and goals. Designs and implements quality assurance training programs to key personnel in conjunction with managers. Prepares and maintains control plans and revises/audits processes, responds to customers quality concerns. Manage client and regulatory authority audits Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for entire organization Author or Review validation documentation (plans, protocols, test suites, reports, etc.). Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented. Coordinates client specific validation activities with practice leads. Enforce QA requirements for IT quality systems with potential GxP impact. Support GxP decisions/strategies during validation projects. Document applicable deviations and documentation anomalies for computer systems undergoing validation. Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met. Review requirements, traceability matrices, test suites and test executions. Travel involved. Other duties as assigned. KRA spread: QMS and corporate Quality management: 60% Validation: 40% Location - Madhapur, Hyderabad, Telangana,

As a Senior Manager - Alternator Design & Development , you will lead the entire product lifecycle of alternators for automotive applications. This is a deeply technical, hands-on role demanding expertise in core alternator engineering not a project management position. You will architect designs, resolve complex engineering challenges, and validate performance through rigorous testing Key Responsibilities: Technical Leadership: Own end-to-end alternator design, from concept to production, ensuring compliance with automotive standards. Conduct advanced FEA simulations (electromagnetic, structural, thermal) to optimize performance, durability, and NVH. Lead DFMEA, root cause analysis, and design validation plans. Core Engineering: Design and refine armature windings, rotor assemblies, and magnetic circuits for efficiency, power density, and manufacturability.Develop voltage regulation strategies and mitigate electrical/mechanical losses. Resolve NVH challenges through structural and electromagnetic optimization. Validation & Testing: Define and execute alternator testing methodologies (performance, durability, environmental).Analyze test data to drive design improvements and ensure reliability targets. Cross-functional Collaboration: Interface with manufacturing, suppliers, and customers to ensure design feasibility and scalability. Mentor junior engineers in alternator design principles.

Role & responsibilities Good exposure to DO 178B/C Strong C knowledge & excellent debugging skills Strong exposure to HSIT Testing methods (BVA, ECP and so on) Testing Levels Unit, Integration & Validation Structural coverage, DC & CC RTRT/LDRA/any other tools Project exposure to test bench & simulators Knowledge on configuration & change management System/Software Requirement Analysis Develop/Update system/software level test case/procedures Test execution and result analysis Writing test case and test procedures Test execution and result analysis Produce test report Qualifications Bachelors Degree in Computer Science, Information Systems, or other related field, or equivalent work experience Additional course or certification in Business Analysis Essential skills RTRT/LDRA VectorCast Do-178b Embedded C Doors RTOS Experience 4-8 Years

1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation. 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failure. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenario. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slicing variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets. Document inconsistencies

1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation. 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failure. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenario. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slicing variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets. Document inconsistencies

Aseptic line for Beverages Required Candidate profile should have worked in the aspetic line in phrama or beverages lines only

Role & responsibilities Candidate must have relevant experience in in statistical / mathematical modeling, quantitative research, counterparty and market risk management, or related field at a reputed bank, investment or broker services, asset management firm or a consulting firm. Wider skill requirements include: Independently built and managed quantitative market and counterparty risk analytical models Strong experience/knowledge in at least some of the following areas (in quant space) Counterparty Credit Risk (PFE, CVA, XVA) Pricing and valuation - Derivatives (across one or more asset classes) Modeling of Risk Metrics (e.g, EPE, PFE, RWA, Greeks) Market Risk Scenarios and Stress Testing Development, prototyping and back-testing of Monte Carlo Credit Exposure Models Incremental default risk, specific risk charge and stressed VaR Worked on multiple Market Risk Models like to develop/review calculation of VaR(Historical, Parametric and Monte Carlo), RNiV, CCAR, IRC Model Validation/ development and present value for various type of instruments using any statistical tool Strong experience/knowledge in at least some of the following areas (business knowledge) Good knowledge of market risk concepts: Risk Factor, VAR, Earning at Risk, cash flow at risk, ETL, PV01, Independent Validation, Exotic derivatives, FX, Interest rate derivatives, volatility, commodities, credit derivatives, Fixed income, Hull & White, Monte Carlo simulation, Capital calculationso Knowledge and experience with counterparty risk concepts (PFE,SA-CCR, EPE etc Leveraging experiential know-how of a wide range of financial products like Equity, Derivative, Swaps, IR, Credit derivatives, OTC products, Swaps, Securitization, CDO's etc. Knowledge of one or more of global regulatory Topics BASEL II/III, IFRS 9, CCAR/DFAST, CECL, FRTB, SR-11/7 around data sufficiency, modeling methods, industry standards etc. Assisted clients to design and implement strategic and functional changes across risk management, treasury, front office, middle office, and back office activities with a focus on risk and valuation processes, regulatory compliance, analytics, strategy, and organizational Preferred candidate profile

Credit Risk Analytics Professional Job Specification: Candidate would be responsible for developing, validating, auditing and maintaining credit risk models. Candidates would be expected to support financial institutions on meeting jurisdictional regulatory requirements and their broader risk management initiatives. Multiple positions required; Experience level 2-12 years of experience; Location: Bangalore Core Skill Requirements Candidate must have relevant experience in in statistical / mathematical modeling, quantitative research, credit risk management, or related field at a reputed bank, investment or broker services, asset management firm, Insurance provider or a consulting firm. Wider skill requirements include: Experience in Credit Risk Modeling PD/LGD/EAD TTC, PIT, Stressed and unstressed portfolio Experience in Model Development, Model Validation, Model Audit (implementation and execution experience will not be considered directly relevant) Knowledge of one or more of global regulatory norms - CECL, IFRS 9, CCAR/DFAST, Basel II/III, SR-11/7, E-23 around data sufficiency, modeling methods, industry standards etc. Well versed with one or more statistical techniques used in credit risk modeling – Logistic Regression, Time series, OLS, Probit models, Survival techniques, Tobit, Fractional Logistic, Beta model, State Transition Matrix, Single Factor Merton model etc. Experience in Machine learning algorithms like Random Forest, SVM, Neural Network etc. and Artificial Learning use cases such as Natural Language Processing, Robotics etc. will be a plus Proficiency in one or more analytical tools such as SAS, R, Python, Matlab, Scala, VBA etc. Experience in Data Science and cloud based analytics platform will be a plus Understanding of credit risk metrics like RWA, Expected loss, Regulatory and Economic capital, OTTI, Watchlist, Asset quality etc. Conceptual understanding of the data and methodology used for credit risk regulatory models Leveraging experiential know-how of a wide range of loan types, including C&I, CRE, RRE, ABL, Leasing, Credit Card, Vehicle, Personal etc. Prior experience in domains like commercial banking, retail banking, treasury, investment management and strong knowledge of risk data analysis and development, strategy design and delivery deployment. Vendor Experience Experience in bureau data from credit unions e.g. D&B, Experian, Equifax, Transunion Experience in vendor models and ratings like Fitch, Credit pro, Moody etc. Knowledge about external / benchmark models on consumer portfolios is a plus (FICO Score, Standards and Poor's, Fitch or Moody's Ratings) Selecting, implementing and/or using commercial credit risk workflow, analytics- e.g., Moody's KMV, S&P and/or, reporting technologies- e.g., Oracle, Cognos, et al. Non-functional skill requirement Preferred candidate profile

Credit Risk Analytics Professional Job Specification: Candidate would be responsible for developing, validating, auditing and maintaining credit risk models. Candidates would be expected to support financial institutions on meeting jurisdictional regulatory requirements and their broader risk management initiatives. Multiple positions required; Experience level 2-12 years of experience; Location: Bangalore Core Skill Requirements Candidate must have relevant experience in in statistical / mathematical modeling, quantitative research, credit risk management, or related field at a reputed bank, investment or broker services, asset management firm, Insurance provider or a consulting firm. Wider skill requirements include: Experience in Credit Risk Modeling PD/LGD/EAD TTC, PIT, Stressed and unstressed portfolio Experience in Model Development, Model Validation, Model Audit (implementation and execution experience will not be considered directly relevant) Knowledge of one or more of global regulatory norms - CECL, IFRS 9, CCAR/DFAST, Basel II/III, SR-11/7, E-23 around data sufficiency, modeling methods, industry standards etc. Well versed with one or more statistical techniques used in credit risk modeling – Logistic Regression, Time series, OLS, Probit models, Survival techniques, Tobit, Fractional Logistic, Beta model, State Transition Matrix, Single Factor Merton model etc. Experience in Machine learning algorithms like Random Forest, SVM, Neural Network etc. and Artificial Learning use cases such as Natural Language Processing, Robotics etc. will be a plus Proficiency in one or more analytical tools such as SAS, R, Python, Matlab, Scala, VBA etc. Experience in Data Science and cloud based analytics platform will be a plus Understanding of credit risk metrics like RWA, Expected loss, Regulatory and Economic capital, OTTI, Watchlist, Asset quality etc. Conceptual understanding of the data and methodology used for credit risk regulatory models Leveraging experiential know-how of a wide range of loan types, including C&I, CRE, RRE, ABL, Leasing, Credit Card, Vehicle, Personal etc. Prior experience in domains like commercial banking, retail banking, treasury, investment management and strong knowledge of risk data analysis and development, strategy design and delivery deployment. Vendor Experience Experience in bureau data from credit unions e.g. D&B, Experian, Equifax, Transunion Experience in vendor models and ratings like Fitch, Credit pro, Moody etc. Knowledge about external / benchmark models on consumer portfolios is a plus (FICO Score, Standards and Poor's, Fitch or Moody's Ratings) Selecting, implementing and/or using commercial credit risk workflow, analytics- e.g., Moody's KMV, S&P and/or, reporting technologies- e.g., Oracle, Cognos, et al. Non-functional skill requirement Preferred candidate profile

Role & responsibilities Candidate must have relevant experience in in statistical / mathematical modeling, quantitative research, counterparty and market risk management, or related field at a reputed bank, investment or broker services, asset management firm or a consulting firm. Wider skill requirements include: Independently built and managed quantitative market and counterparty risk analytical models Strong experience/knowledge in at least some of the following areas (in quant space) Counterparty Credit Risk (PFE, CVA, XVA) Pricing and valuation - Derivatives (across one or more asset classes) Modeling of Risk Metrics (e.g, EPE, PFE, RWA, Greeks) Market Risk Scenarios and Stress Testing Development, prototyping and back-testing of Monte Carlo Credit Exposure Models Incremental default risk, specific risk charge and stressed VaR Worked on multiple Market Risk Models like to develop/review calculation of VaR(Historical, Parametric and Monte Carlo), RNiV, CCAR, IRC Model Validation/ development and present value for various type of instruments using any statistical tool Strong experience/knowledge in at least some of the following areas (business knowledge) Good knowledge of market risk concepts: Risk Factor, VAR, Earning at Risk, cash flow at risk, ETL, PV01, Independent Validation, Exotic derivatives, FX, Interest rate derivatives, volatility, commodities, credit derivatives, Fixed income, Hull & White, Monte Carlo simulation, Capital calculationso Knowledge and experience with counterparty risk concepts (PFE,SA-CCR, EPE etc Leveraging experiential know-how of a wide range of financial products like Equity, Derivative, Swaps, IR, Credit derivatives, OTC products, Swaps, Securitization, CDO's etc. Knowledge of one or more of global regulatory Topics BASEL II/III, IFRS 9, CCAR/DFAST, CECL, FRTB, SR-11/7 around data sufficiency, modeling methods, industry standards etc. Assisted clients to design and implement strategic and functional changes across risk management, treasury, front office, middle office, and back office activities with a focus on risk and valuation processes, regulatory compliance, analytics, strategy, and organizational Preferred candidate profile

Excellent opening for Process Validation role in Quality Assurance in Unison Pharmaceuticals, Moraiya Company: Unison Pharmaceuticals Website: www.unisonpharmaceuticals.com Department: Quality Assurance Location: Unit III, Moraiya, Ahmedabad Designation : Process Validation: Executive/Sr. Executive Experience: 3-9 Years (In PV) Qualification: B.Pharm/M.Sc Job Description : Prepare process validation protocol and send for review, approval and authorization to concern team members Facilitate process validation training to production, QC and IPQA Collect samples from Granulation, Compression / Capsule filling and Coating stages and send to QC for analysis Perform required documentation activities like; utilization log and test request slip Compile data for each batch performed under validation stage Prepare process validation report post completion of the 3 validation batches and send the report for review and approval Please submit your resume to career@unisonpharmaceuticals.com to be considered for this role. Join our team at Unison Pharmaceuticals and take the first step towards a rewarding career.

* Manage daily operations of the biochemistry lab, ensuring timely processing & reporting of samples. * Oversee test validations, calibrations, & troubleshooting of analyzers & instruments. * Optimize workflow & ensure adherence to TAT benchmarks.

Synnat Pharma Pvt Ltd seeks a proactive Maintenance Executive to ensure equipment reliability and minimize downtime at our Visakhapatnam API manufacturing facility. You will execute preventive maintenance, troubleshoot malfunctions, manage spare parts, and collaborate on corrective actions. Responsibilities include overseeing civil/fabrication activities, adhering to SOPs, and maintaining documentation. Strong technical problem-solving skills and a commitment to quality/safety are essential. Job Details: Industry: API Manufacturing Department: Maintenance Role: Maintenance Executive Location: Visakhapatnam Compensation: 2-4 LPA Experience: 1-3 years Qualification: Bachelor's Degree in Mechanical Engineering, Electrical Engineering, or a related field Responsibilities: Develop and implement preventive maintenance schedules (PPM) for process and critical equipment, adhering to industry best practices and Synnat Pharma's SOPs. Conduct equipment inspections and performance monitoring to proactively identify and address potential issues. Analyze maintenance data to identify trends, predict equipment failures, and optimize PPM schedules. Respond to equipment breakdowns, troubleshoot issues, and perform necessary repairs on mechanical, electrical, and instrumentation systems. Manage spare parts inventory, ensuring critical items are readily available for timely repairs. Oversee basic civil and fabrication activities related to facility and equipment maintenance. Maintain accurate maintenance documentation, including manuals, SOPs, schedules, and repair records. Ensure all maintenance activities comply with regulatory requirements (FDA, cGMP). Implement corrective actions to prevent recurrence of equipment failures and improve reliability. Collaborate with production to schedule maintenance, minimizing disruption and maximizing uptime. General Expectations and Past Experiences: 1-3 years' Maintenance Executive experience in API Manufacturing (Preventive Maintenance, Troubleshooting). Hands-on experience: Civil/Fabrication, Mechanical/Electrical Systems Repair (Pharmaceutical). Solid understanding of API Manufacturing, Equipment Validation, and SOPs. Proven ability to develop Maintenance Schedules, reduce Downtime, and execute Corrective Actions. Familiarity with Procurement, Spare Parts, and Maintenance Documentation. Excellent Teamwork & Communication skills. Proficient in Maintenance Risk Assessment and Best Practices.

Dear Candidate, We have an urgent opening in Test & Development role. Candidate should be graduated with BE/B.Tech. Role & responsibilities 1. Machine build, SOPs, testing as per various test standards. 2. Protoshop facility operational execution for test needs on man, machine engagement for product delivery. 3. Product build/test documentation and upkeep. 4. Components handling, assembly, installation, functioning, trouble shooting and corrective actions. 5. Field test experience will be an added advantage. Preference would be given to those having worked in test instrumentation and analysis, field correlations and endurance (MTBF analysis). 6. Experience on test standard development is expected 7. Should be able to work and guide a team of test engineers and operators within the company and partner associates 8. Should have good understanding of concepts and strong analytical skills apart from good communication skills. 9. Recording of failures, report preparation, closer of concerns. Key Deliverables: 1. Machine Build 2. Machine Endurance 3. Machine DVPSOR Testing 4. Machine Performance testing Interested one`s can share their Cv at swati.shikha@mounttalent.com or can reach me 9560495550.

Role & responsibilities To operate fermenters (50L to 4KL), Nutrient dosing vessels, Media preparation vessels and CIP tanks. • To perform raw material dispensing monitoring, media preparation, media transfer and CIP solution preparation. • Preparatory work required for actual production batches which includes (but not limited to) issuance of material, preparation of stock solutions, sterilization of glassware, sterilization of filters etc. • Execution of production batches as per production schedule. • To perform fermenter and process vessel sterilization and cleaning activities. • To perform downstream activities such as centrifugation, slurry preparation, spray drying, Blending and sifting. • Adherence to SOPs, BMRs and product specifications. • Seed and production fermenter operation, batch monitoring, harvesting and CIP. In process sampling and analysis as per STP. • Participate in Equipment and system qualification and documentation. • To Maintain log records, batch records, deviation report and shift handover reports. • Adherence to good manufacturing practices, good documentation practices and safety compliance. • Follow up of calibration and validation of equipment as applicable as per schedule. • To work in shifts and monitoring of all production activities in Shift. • To participate in SOP ,BMR and production formats preparation • To ensure the production documentation completion by team. • To coordinate with maintenance team for planning preventive maintenance activities • To issue MRN to stores, Batch booking to QA, issue the finished product analytical testing report to QC. • Training, supervising, monitoring plant assistants / helpers. • To supervise housekeeping activities.