107 Oq Jobs - Page 2

Capgemini Invent Capgemini Invent is the digital innovation, consulting and transformation brand of the Capgemini Group, a global business line that combines market leading expertise in strategy, technology, data science and creative design, to help CxOs envision and build whats next for their businesses. Your Role Use Design thinking and a consultative approach to conceive cutting edge technology solutions for business problems, mining core Insights as a service model Engage with project activities across the Information lifecycle. Understanding client requirements, develop data analytics strategy and solution that meets client requirements Apply knowledge and explain the benefits to organizations adopting strategies relating to NextGen/ New age Data Capabilities Be proficient in evaluating new technologies and identifying practical business cases to develop enhanced business value and increase operating efficiency Architect large scale AI/ML products/systems impacting large scale clients across industry Own end to end solutioning and delivery of data analytics/transformation programs Mentor and inspire a team of data scientists and engineers solving AI/ML problems through R&D while pushing the state-of-the-art solution Liaise with colleagues and business leaders across Domestic & Global Regions to deliver impactful analytics projects and drive innovation at scale Assist sales team in reviewing RFPs, Tender documents, and customer requirements Developing high-quality and impactful demonstrations, proof of concept pitches, solution documents, presentations, and other pre-sales assets Have in-depth business knowledge across a breath of functional areas across sectors such as CPRD/FS/MALS/Utilities/TMT Your Profile B.E. / B.Tech. + MBA (Systems / Data / Data Science/ Analytics / Finance) with a good academic background Minimum 10 years + on Job experience in data analytics with at least 7 years ofCPRD, FS, MALS, Utilities, TMT or other relevant domain experience required Specialization in data science, data engineering or advance analytics filed is strongly recommended Excellent understanding and hand-on experience of data-science and machine learning techniques & algorithms for supervised & unsupervised problems, NLP and computer vision Good, applied statistics skills, such as distributions, statistical inference & testing, etc. Excellent understanding and hand-on experience on building Deep-learning models for text & image analytics (such as ANNs, CNNs, LSTM, Transfer Learning, Encoder and decoder, etc). Proficient in coding in common data science language & tools such as R, Python, Go, SAS, Matlab etc. At least 7 years experience deploying digital and data science solutions on large scale project is required At least 7 years experience leading / managing a data Science team is required Exposure or knowledge in cloud (AWS/GCP/Azure) and big data technologies such as Hadoop, Hive What you will love about working here We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance. At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities. Equip yourself with valuable certifications in the latest technologies such as Generative AI. About Capgemini Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of 22.5 billion.

Role & responsibilities Execute and review Equipment Qualification protocols (IQ, OQ, PQ) in compliance with regulatory requirements. Prepare, execute, and review Cleaning Validation protocols and reports . Participate in the design, execution, and documentation of Computer System Validation (CSV) as per GAMP 5 guidelines. Coordinate and support Process Validation activities, including preparation and review of protocols, execution, and final reporting. Ensure that all validation activities are compliant with cGMP, regulatory guidelines , and internal SOPs. Perform gap assessments, risk assessments , and deviation handling related to validation. Collaborate with cross-functional teams including production, engineering, QC, and IT for validation planning and execution. Assist in internal audits, regulatory inspections , and prepare responses to audit observations. Maintain and update validation master plans and SOPs regularly. Skills & Competencies B. Pharm / M. Pharm / M.Sc. in relevant field. Minimum 4 years of hands-on experience in QA validation functions in a regulated pharmaceutical manufacturing environment. Strong understanding of equipment and utility qualification, cleaning validation, CSV, and process validation . Familiar with guidelines such as GAMP 5, 21 CFR Part 11, ICH Q8-Q10 , and applicable regulatory standards. Good documentation and analytical skills. Proficient in MS Office , knowledge of QMS software is an advantage. Strong communication and coordination skills.

Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the overall strategy of the line of business / business unit Quality control and Customer satisfaction Support the completion of Annual Customer Satisfaction survey by ensuring completion of survey by the account customers, representatives for various projects within the account. Ensure completion of survey and address any queries in a timely manner. Support in conceptualizing the action planning by communicating with clients and interacting with Delivery Managers, vertical delivery heads and service delivery heads Drive the account wise tracking of action planning identified for sustained CSAT in various projects. Drive the Quarterly pulse survey for selected accounts or projects for periodic check-ins. Support the Account Leadership teams for tracking and managing client escalation for closure. Early Warnings and Business partnership Drive the implementation of mechanisms for preventing client escalations / dis-satisfactions by creating an early warning system in DigiQ covering aspects like delivery quality, delivery schedule, resources constraints, financial issues (overloading of effort / over-run potential), productivity, and slippages on milestones. Participate in Monthly and Quarterly Business review along with Business and Account leadership to ensure adherence of defined quality processes, define new life cycle models and ensure gating processes are followed the projects within the accounts. Drive the upskilling of delivery teams on quality management tools, knowledge management and create mechanisms for sharing of best practices. Support the collection of metrics on the performance / health of process and regular publishing of compliance and metrics dashboards. Continuous Improvement Drive a culture of continuous improvement in the assigned accounts to ensure enhance efficiency and productivity of resources Create mechanisms between the projects in the account for sharing knowledge, quality issues, risk mitigation methods within the accounts to drive the continuous improvement Plan and drive year on year improvement goals in various projects by way of process streamlining & improvements and automation, leading to cost savings and / or efficiency Support the collection of metrics to show the improvements- efficiency / productivity improvement. Team Management Team Management Clearly define the expectations for the team Assign goals for the team, conduct timely performance reviews and provideconstructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop theirprofessional competence Drive geography specific trainings for the quality team, designed basis the statutory norms that apply in different countries Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the tea Track team satisfaction scores and identify initiatives to build engagementwithin the team Mandatory Skills: SAP FS-CM Functional. Experience: 8-10 Years.

Job description BMS Validation Project - Execution SCADA Validation Project - Execution PLC System Validation Project - Execution To Handle the site engineers as per the project given by Head / Senior To prepare the work reports related to projects

Role & responsibilities: 1. Responsible for overall co-ordination with all relevant stake holders from the project Team, Engineering/consultation company and SC Finish Goods Manufacturing Teams for the project delivery. 2. Preparation/Review of PFDs (Process flow diagrams) for the formulation/Standardization and downstream processes with Engineering company. 3. Best sutaible Plant Layout preparation support to Engineering company. 4. Material and Man Movement plan preparation for new SC Operations plant in co-ordination with Project Engineering and Management Team. 5. Sizing calculations for Liquid and Solid storage with internal plant vehicle Transport layout preparation. 6. Conduct design reviews of the detail Engineering drawings, Mechanical & Piping P&ID prepared by Engineering company. 7. Compliance to all Food safety/Regulatory/EHS requirements during early design phase. 8. Support in preparation and reviewing deatil sizing of RM and PM storage with all the RM/PM material requirement and Movement plan. 9. Review of DQ, IQ, HQ & OQ for new equipments and delivery of the same for the process. 10. Closely work with Global and India Supply Chain Operations stakeholders. Preferred candidate profile 1. The Person should be having extensive experience in bulk liquid standardisation/Formulation plant process Engineering with individually handled the green Field project as user Manager. 2. Bachelor of Engineering Chemical/Mechanical with 20-25 years of experience in process industry- Food/Pharma/biotech/Chemical.

Role & responsibilities : 1 Execution of Process equipment IQ and OQ 2 Maintenance and changeover of Vial washing, Tunnel, filling and capping machine 3 Operation and maintenance of Lyo 4 Responsible for shift maintenance 5 Maintenance of Autoclaves, DHS, Process vessels 6 Responsible for execution of preventive maintenance activities as per schedules and checklist 7 Responsible for handling the process equipment breakdown activities to minimize the equipment down time. 8 Record and maintaining of preventive maintenance logbooks and schedules as per cGMP 9 Responsible for spare parts availability. 10 Ensure the safety at workplace. Preferred candidate profile: Qualification: ITI/Diploma (Mechanical)

Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, and PQ for the equipment’s. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipment’s in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer. Preferred candidate profile ITI/ DIPLOMA/ B. TECH/ Pharmacy With Relevant experience

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)

4+ years of strong working experience with Oracle Apps DBA activities.Experience in installation,configuration,Tuning maintenance and upgrade of Oracle application 11i/R12.Should have hands on experience in multi-node/single node cloning of R12.2 Application and Database cloning.Must be well versed with AD Utilities,ADOP and FS Clone.Experience in Patching Application, Database, WebLogic Oracle EBS and Database DR creation,maintenance,switchover testing.Experience in SSO and OID implementation and integration with Oracle EBS R12.Experience with Load balancing of application tier and setting up parallel concurrent processing and Shared Appl Top.Excellent troubleshooting skills on issues releated to Apache,Application Stack,Weblogic and DB.Must have strong working knowledge about concurrent manager,workflow admin and AD UtilitiesAble to independently work on assignments and interact with diverse team (Unix,network,functional/technical users).OCI admin is prefferedMust be very good at Trouble Shooting and Root Causing issues arising out of day to day production operations.Ready to work in flexible Shifts as demanded by project or task being done. Qualifications Graduate Job Location

Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will engage in the analysis and design of innovative business processes. Your typical day will involve collaborating with various stakeholders to create comprehensive documentation that directs the implementation of new processes and technologies. You will work closely with the business to define product requirements and use cases, ensuring that they align with both process and functional requirements. Additionally, you will participate in user and task analysis to accurately represent the needs of the business, facilitating effective communication and understanding among all parties involved. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Facilitate workshops and meetings to gather requirements and feedback from stakeholders.- Develop and maintain process documentation to ensure clarity and consistency across the organization. Professional & Technical Skills: - Must To Have Skills: Proficiency in Computer System Validation (CSV).- Strong analytical skills to assess business processes and identify areas for improvement.- Experience in process mapping and documentation techniques.- Ability to collaborate effectively with cross-functional teams.- Familiarity with business process modeling tools and methodologies. Additional Information:- The candidate should have minimum 3 years of experience in Computer System Validation (CSV).- This position is based at our Pune office.- A 15 years full time education is required. Qualification 15 years full time education

Hands-on experience in PLC programming, troubleshooting & commissioning using Siemens S7 software. Knowledge of control systems, HMI/SCADA, automation panels & industrial process control

Preparation of Qualification documents: URS, DQ, FDS, Risk Assessment, IQ, OQ, PQ and Operation SOP of different equipment / instrument / utility. Initiation of change controls and CAPA related to Equipment / instrument / utility. Person should have hands on experience in qualification of autoclave, vial washer, depyrogenation tunnel, Filling Machine, capping machine, lyophilizer etc. Person should have exposure / understanding of qualification of packing equipment

Role & responsibilities Will be responsible for handling HVAC , water treatment plant, compressed air, handling of bolier /chiller/air compressor & ETP and pharmaceutical machinery, repairs and maintenance. Handling BMS systems, handling PLCs and DQ, IQ and PQ. Keeping equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and established procedures, requesting special services. Will be involved in handling all pharmaceutical machinery. Responsible for confirming system and product capabilities by designing feasibility and testing methods, testing finished product and system capabilities; confirming fabrication ,assembly, and installation processes. Responsible for keeping equipment operational by coordinating maintenance and repair services; Maintain product and company reputation by complying with government regulations Develop processes by designing and modifying equipment as per the requirement and making sure the project is completed by training and guding technicians. Prepare reports by collecting, analizing and summarizing information and trends. Provide engineering information by answering questions and request. Maintain system and process data base by writing computer program and entering data Handle Autocad, Microsoft word , Power point & Excel Responsible for Attending educational workshop; reviewing professional publications; establishing personal network; participating in professional socities. Prepare road map would be heading the engineering department. Responsible for any other assignment allocated by the department head.

About the Role: Grade Level (for internal use): 08 The Role Implementation Engineer The Team The Portfolio Analytics (PA) Application Support team is responsible for onboarding and supporting clients on the Capital IQ platform. Historically focused on manual ingestion workflows and reactive troubleshooting, the team is now evolving to take on a more technical, proactive, and scalable approach. This role will be key in driving that transformation building automation, scripting ingestion processes, and supporting API-based integrations. The Impact This is not just another support role. You will be part of the teams next chapter helping shift from manual operations to automated, scalable solutions . Your technical contributions will improve the client onboarding experience, reduce turnaround time, enhance data accuracy, and free up the team to focus on more strategic tasks. Youll work across client use cases, internal tooling, and automation pipelines directly shaping the future of support within Portfolio Analytics. Responsibilities Support client onboarding by implementing batch ingestion jobs and API integrations Develop and maintain Python scripts for data preprocessing and validation workflows Help automate recurring ingestion tasks , moving away from manual interventions Troubleshoot ingestion or integration issues by working across data, scripts, and scheduling systems Build internal tools and reusable components to support ingestion and workflow scalability Collaborate with Product and Engineering on testing and deploying new ingestion features Maintain technical documentation to standardize and scale implementation support Partner with client-facing teams to deeply understand use cases and deliver technical solutions What Were Looking For 02 years of experience in a technical role (support, implementation, automation, or scripting) Proficiency or strong familiarity with Python and basic scripting logic Understanding of REST APIs and data formats such as JSON, CSV, Excel Exposure to SQL or file-based data manipulation tools (e.g., pandas, shell scripts) Interest in solving operational problems through automation and process improvement Ability to learn financial data structures such as portfolios, benchmarks, and securities Strong analytical and troubleshooting skills, with excellent attention to detail Bachelors degree in Computer Science, Engineering, or a related discipline Why This Role Matters Now As we scale Portfolio Analytics across a growing client base, ingestion and automation will be at the core of our success. This role is an opportunity to join that journey early helping redefine how support is delivered and building the technical foundation for what comes next. About S&P Global Market Intelligence At S&P Global Market Intelligence, a division of S&P Global we understand the importance of accurate, deep and insightful information. Our team of experts delivers unrivaled insights and leading data and technology solutions, partnering with customers to expand their perspective, operate with confidence, andmake decisions with conviction.For more information, visit www.spglobal.com/marketintelligence . Whats In It For You Our Purpose: Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technologythe right combination can unlock possibility and change the world.Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence, pinpointing risks and opening possibilities. We Accelerate Progress. Our People: Our Values: Integrity, Discovery, Partnership At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals. Benefits: We take care of you, so you cantake care of business. We care about our people. Thats why we provide everything youand your careerneed to thrive at S&P Global. Health & WellnessHealth care coverage designed for the mind and body. Continuous LearningAccess a wealth of resources to grow your career and learn valuable new skills. Invest in Your FutureSecure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs. Family Friendly PerksIts not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families. Beyond the BasicsFrom retail discounts to referral incentive awardssmall perks can make a big difference. For more information on benefits by country visithttps://spgbenefits.com/benefit-summaries Global Hiring and Opportunity at S&P Global: At S&P Global, we are committed to fostering a connected andengaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. Our hiring practices emphasize fairness, transparency, and merit, ensuring that we attract and retain top talent. By valuing different perspectives and promoting a culture of respect and collaboration, we drive innovation and power global markets. Recruitment Fraud Alert If you receive an email from a spglobalind.com domain or any other regionally based domains, it is a scam and should be reported to reportfraud@spglobal.com. S&P Global never requires any candidate to pay money for job applications, interviews, offer letters, pre-employment training or for equipment/delivery of equipment. Stay informed and protect yourself from recruitment fraud by reviewing our guidelines, fraudulent domains, and how to report suspicious activity here. ----------------------------------------------------------- Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person. US Candidates Only The EEO is the Law Poster http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf describes discrimination protections under federal law. Pay Transparency Nondiscrimination Provision - https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf ----------------------------------------------------------- 20 - Professional (EEO-2 Job Categories-United States of America), IFTECH203 - Entry Professional (EEO Job Group), SWP Priority Ratings - (Strategic Workforce Planning)

BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience

BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience

BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience

BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience

BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience

BE / Diploma - Mechanical Engineering with 6+ years of experience in Quality Department. Must Have Clean Room Experience Having Knowledge to prepare SOPs, DQ, IQ, OQ. Good Communication & Computer Skills. Required Candidate profile As per ISO & Cleanroom / Industry standards, Clean Room products- Equipment / Lab Furniture / HVAC / Air Handling Units Industry etc. Experience in Manufacturing Industry in Quality Dept is preferred. Perks and benefits Negotiable - Depending Upon Candidate & Experience

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in CSV and excellent leadership skills. Roles and Responsibility Lead the development and implementation of CSV strategies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and mitigate risks associated with CSV. Develop and maintain relationships with key stakeholders, including regulators and industry partners. Provide training and guidance on CSV best practices to team members. Conduct audits and assessments to ensure adherence to CSV standards. Develop and implement process improvements to enhance CSV efficiency and effectiveness. Job Requirements Strong knowledge of CSV principles and regulations, including FDA guidelines. Excellent leadership and communication skills, with the ability to motivate and guide team members. Experience working in a fast-paced environment with multiple priorities and deadlines. Strong analytical and problem-solving skills, with attention to detail and the ability to identify risks. Ability to work collaboratively with cross-functional teams, including sales, marketing, and engineering. Strong understanding of quality management systems and ISO standards. Location- Bengaluru,Chandigarh,Dadra & Nagar Haveli,Daman,Diu,Goa,Haveli, Jammu, Lakshadweep, Nagar,New Delhi,Puducherry,Sikkim

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview TE Connectivity's Manufacturing and Process Development Engineering Teams significantly impact LEANPD driven new product development projects, driving for excellence in existing manufacturing technologies and methods and striving to implement new manufacturing technologies to provide improved process and tolerance control. They act as the binding element between product development and manufacturing engineering, ensuring the effectiveness and efficiency of this critical interface. They support Product Development in the optimization of designs and piece parts for manufacturability by realizing sample tooling/products/prototypes. They also design, develop, and qualify tooling and processes to meet TE quality and production standards, document all processes and tooling in applicable TE systems, support supply chain to verify supplier compliance and capability, initiate and implement programs to continuously improve quality, cost and cycle time and adhere to all appropriate specifications, regulatory requirements and customer requirements. Responsibilities Complete prototype building and product testing in association with R&D Engineers. Complete process development to support new product development and implement manufacturing lines with the project teams. Conceptualize, source debug, and introduce new/improved Jig and Fixture designs. Preparation of Manufacturing Procedures & training of product builder personnel. Prepare and maintain Preventative Maintenance Schedules. Troubleshoot and repair line defective equipment. Ownership of line yield and output. Provide weekly updates and highlight yield issues and implement fixes to the team. Provide technical leadership and have the ability to motivate and influence production personnel. Display customer focus at all times and be accountable for quality and timeliness of own work. Compile IQ / OQ protocols and execution of same. Assist team in performing design testing. Fixture Maintenance /Calibration ownership for respective equipment. Basic understanding of QMS system. What your background should look like: Diploma in Mechanical /Production 2+ years experience in a similar role. Knowledge of Medical Device development/manufacture with previous work experience in Design an advantage. Jigs & Fixtures design and fabrication experience preferable. Experienced with all the popular software applications for generating office documents, spreadsheets, project plans, etc. Experience in execution of lab testing an advantagee.g. tensile testing, torque testing etc. Experienced in IQ/OQ/PPQ documentation preparation, execution. AutoCAD/Solid works experience preferable. Knowledge of Six-Sigma and Lean Engineering principles an advantage. Knowledge of equipment, process and product validation processes, ability with statistical data analysis. Dynamic, flexible approach to work with a results-oriented attitude. Comfortable operating within a team environment. Motivated to work on own initiative. Good communication and organisational skills. Proven track record of excellent timekeeping & attendance is essential. Basic Understanding of QMS Competencies

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)

Key requirements for this role are as follows: Excellent Communication skills Stakeholder comms Progress updates Comms related to Risk/Issue Outstanding Planning skills (using Agile/SAFe) Scope Clarity and Goal Setting Art of breaking down the work Estimation Work Allocation Risk and Dependency Management Strong Tracking and Monitoring Tracking progress Identifying and Raising Risks Behaviours Accountability/Ownership demonstrated Ability to work cohesively with people/teams Domain Should have preferably worked in Capital Markets Mandatory Competencies Agile - Agile FS Domain - Capital Market Beh - Communication

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM