701 Capa Jobs - Page 9

Role & responsibilities Oversee and manage the entire manufacturing process. Handle Granulation, Compression , Coating and all other production related activities. Active calculation, dispensing of Raw Materials and batch reconciliation at various stages. In process checking at various intermediate stages of Granulation, Compression and Coating. Prepare IQ, OQ, & PQ of the process & utility equipment. Should handle process of validation batches Ensure online documentation of production activity on timely basis. Review of batch manufacturing record and other related documents for its completion of intermediate and final stage. Maintain the SOPs, Log books and other documents. BMR / BPR preparation in ERP and review.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.

We are looking for a highly skilled and experienced Quality Manager to lead and oversee all quality assurance activities in our manufacturing unit. The ideal candidate will ensure that products meet quality standards and regulatory requirements

Manage the Quality Assurance function at manufacturing site Ensure compliance with ISO, GMP & REACH standard Develop, implement & monitor Quality Management Systems including SOPs, documentation & CAPA systems Handle customer complaints, conduct RCA Required Candidate profile 8–12 years of experience in QA, preferably in specialty chemicals Knowledge of analytical instruments, QC processes & technical documentation Strong knowledge - ISO 9001, GMP & other quality standards

Posted On 03rd Apr, 2025 : Role Overview: The Quality Head will be responsible for defining, implementing, and maintaining world-class quality assurance strategies across manufacturing operations, supplier quality, regulatory compliance, and injection molding processes. The role requires strong leadership, analytical thinking, and expertise in industry best practices to promote a strict quality control culture within the organization. Key Responsibilities: Quality Strategy & System Implementation Develop and implement Quality Assurance (QA) and Quality Control (QC) systems aligned with ISO 9001, ISO 14001, ISO 45001 (Occupational Health & Safety), and ESD S20:21 (Electrostatic Discharge Protection). Define and drive KPIs for quality performance, including First Pass Yield (FPY), Defect Per Million Opportunities (DPMO), and Cost of Poor Quality (COPQ). Establish and ensure strict adherence to Standard Operating Procedures (SOPs) for inspection, testing, and validation at every stage of production. Promote a strict quality control culture across all teams, ensuring that every employee understands the importance of quality in manufacturing. Manufacturing of LED TVs, Injection Moulding & Supplier Quality Management Oversee incoming (IQC), in-process (PQC), and final product quality (OQC)to minimize defects and rework. Implement Electrostatic Discharge (ESD) Protection (ESD S20:21) measures to ensure the safety and reliability of electronic components. Work closely with suppliers to improve the quality of raw materials, plastic components, and electronic parts. Conduct supplier audits and enforce compliance with RoHS, REACH, and BIS standards. Manage and optimize injection molding quality control, including: Material selection and testing (resins, polymers). Process parameter optimization to minimize defects such as warping, sink marks, and short shots. Implementation of real-time monitoring and defect detection technologies. Ensuring compliance with industry best practices for plastic components used in electronic products. Compliance & Certifications Ensure compliance with ISO 9001, ISO 14001, ISO 45001, BIS, RoHS, CE, FCC, and other global regulatory requirements. Lead internal and external audits for regulatory approvals and maintain all necessary certifications. Develop and maintain safety and environmental management systems aligned with international best practices. Customer Quality & Market Feedback Analyze customer complaints, warranty claims, and field failures to identify trends and implement Corrective and Preventive Actions (CAPA). Drive continuous improvement initiatives to reduce product returns, warranty costs, and customer dissatisfaction. Collaborate with the after-sales service team to track product performance and reliability in the field. Continuous Improvement & Innovation Implement Lean, Six Sigma, and Kaizen methodologies to drive continuous quality improvement. Introduce automation and AI-based quality inspection techniques to enhance production efficiency. Develop and conduct regular training sessions to ensure all employees, from factory workers to management, understand and adhere to quality standards. Promote a zero-defect mindset within the organization, ensuring proactive rather than reactive quality management. Key Qualifications & Experience: EducationBachelors/Masters degree in Engineering (Electronics, Mechanical, Manufacturing, or Polymer Science). Experience12+ years in Quality Management, preferably in electronics, home appliances, or automotive manufacturing. Expertise in ISO 9001, ISO 14001, ISO 45001, ESD S20:21, Six Sigma (Green/Black Belt preferred), and SPC (Statistical Process Control). Experience with BIS, RoHS, CE, FCC, and other regulatory standards. Hands-on experience in injection molding quality control, defect analysis, and process optimization. Knowledge of AI-based quality inspection, ERP & Quality Management Software (SAP, MES, etc.) is a plus. Key Skills Required: Strong analytical and problem-solving skills (Root Cause Analysis, 8D, FMEA) Leadership and team-building experience in a factory setup Knowledge of global quality management systems Injection moulding quality control & process optimization Experience with ERP & Quality Management Software (SAP, MES, etc.) Ability to collaborate with R&D, Manufacturing, and Supply Chain teams Why Join Be a part of a fast-growing company with innovation-driven leadership and legacy. Opportunity to implement cutting-edge quality processes in electronics and injection molding. Work with a dynamic and high-impact team in a competitive industry. Key Skills : Company Profile Company is ---s most trusted and leading ODM/OEM brand with a complete Made in --- design, development, and manufacturing process. Established in 1984, is one of ---s leading ODM/OEM manufacturers with four decades of industry expertise. As the official ODM for webOS TV in --- and the only TV ODM with a Dolby License, the company focuses on backward integration to optimize costs and enhance production. With a current manufacturing capacity of 1.4 million units per annum, expanding to 3.2 million with a new facility, Company is set to become a major player in ---s electronics manufacturing sector. Its expertise in hardware and software enables it to deliver high-performance products, reinforcing ---s global technology manufacturing capabilities.

Job Summary: We are seeking a meticulous and dedicated In-Process Quality Inspection Specialist to join our 2W Electric Bike Manufacturing team. The selected candidate will play a crucial role in ensuring the quality of electric bikes by conducting detailed inspections on the production line, focusing on critical components such as the battery. Key Responsibilities: Quality Inspection: Conduct thorough inspections of electric bikes at various stages, with a specific focus on the battery components. Ensure that components meet specified quality standards, safety regulations, and design specifications. Knowledge on Visual , Functional, Electrical & dimensional inspection of parts. Good knowledge in problem solving tools ( 7 QC tools , 8D , why why analysis, CAPA ) Defect Identification: Identify and document any defects, deviations, or non-conformities related to the battery during the production process. Work collaboratively with production teams to address and resolve quality issues promptly. Determine root-cause of deviations non-conforming results and implement appropriate corrective and preventive measures. Documentation: Maintain accurate and detailed inspection records, including photographs and written reports for the battery components. Compile and analyse data to identify trends and areas for improvement. Review production records in relation to quality compliance. Daily closure report 0 @ QDC ISO documentation compliance and record management. Process Monitoring: Monitor and evaluate production processes related to battery components to proactively identify potential quality issues. Collaborate with production teams to implement corrective and preventive actions. Good knowledge on Cell technology and function parameters like IR, Cell dimensions, Nominal voltage, SOC , C-Rate, OCV etc Good knowledge on Battery pack assembly, BCDS (Battery charge- Discharge process), Safety requirement, BCT. Responsible to monitor assembly as per SOP, Process check sheet, OPL etc Good knowledge on testing equipment / Methodology used for Battery. 4M confirmation @ unskilled manpower Training evaluation of unskilled manpower Collaboration: Work closely with cross-functional teams, including production, engineering, and quality assurance, to drive continuous improvement in the quality of battery components. Provide feedback to relevant teams on ways to enhance the overall manufacturing process. Training: Conduct training sessions for production line workers on quality standards and inspection criteria specific to battery components. Ensure that the production team is aligned with and understands quality requirements for these critical components. Audit Support: Assist in internal and external quality audits by providing necessary documentation and insights into the in-process quality controls for battery components. Role & responsibilities

Supports experienced Sourcing Specialists. Works on projects/matters of limited complexity. Gains experience of the procurement process, commercial and contract management. Builds relationships with stakeholders involved in procurement activities. Supports local purchases within limited scope. Key focus area tactical purchasing. - Grade Specific Role OverviewFollows the sourcing strategyOrganizes the process of Request for Proposal RFP as per guidelinesHelps identifying potential providersHas basic knowledge of the Stakeholder community within the work perimeterManages relationships with tactic providersParticipates in analyzing supplier performancesMaintains contact with clients suppliers on specific contract procurement matters Supports delivery of Procurement services into the BusinessUnderstands the P2P process and supplier costs across business Has basic knowledge about cross functional workBuilds knowledge experience in a number of domains of expertiseGeneral Responsibilities AccountabilitiesProvides services according to the scope assigned by the Category to meet specific KPIsSupports Sourcing Specialists in driving small spend RFxExecutes sourcing strategies to obtain quotations to meet internal Stakeholders requirements Ensures correlation between contract, quotes and Purchase Requisition during the validation processResponsive to local Stakeholders in solving dayto day sourcing activitiesCooperates with senior professionals on requests coming from StakeholdersAccountable for process compliance within the work perimeterContributes to global strategy complianceContributes with local input to global categories strategiesContributes to Category sourcing strategy including forecasting, identification, delivery and reporting of savingsContributes to the supplier maintenance process Acts to overall procurement policies and processes Skills (competencies)

Skill required: Marketing Operations - Quality Management Designation: Quality Auditing Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help balance increased marketing complexity and diminishing marketing resources. Drive marketing performance with deep functional and technical expertise, while accelerating time-to-market and operating efficiencies at scale through Data and Technology, Next Generation Content Services, Digital Marketing Services & Customer Engagement and Media Growth Services.Role requires Digital Marketing Ads & Promotion creation/designAct of overseeing all activities and tasks needed to maintain a desired level of excellence. This may include the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. What are we looking for Quality AnalysisQuality AuditingService Quality ManagementHTML5Hyper Text Markup Language (HTML)Ability to perform under pressureProblem-solving skillsResults orientationCommitment to qualityWritten and verbal communication Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Quality Assistant Manager / Deputy Manager: Hatari Cold Forge - Small Screws Manufacturing Key Responsibilities: Lead and manage the Quality Assurance (QA) and Quality Control (QC) functions in the plant. Implement and maintain ISO 9001 / IATF 16949 quality management systems. Monitor in-process quality control , incoming raw material inspection , and final product audits . Handle customer complaints, CAPA (Corrective and Preventive Actions) , and ensure closure within deadlines. Conduct internal quality audits and coordinate with external auditors. Develop and maintain quality documentation (SOPs, Work Instructions, Quality Plans). Use tools like PPAP, FMEA, SPC, MSA, 7QC tools to drive continual improvement. Train shop-floor employees on quality standards and defect prevention. Interface with production, maintenance, and R&D teams to ensure consistent quality output. Preferred Qualifications: Education: Diploma / B.E / B.Tech in Mechanical Engineering or related field. Experience: 5-10 years in quality control/quality assurance in a precision component or fastener manufacturing industry. Technical Skills: Knowledge of cold forging processes is a strong advantage. Proficiency in quality tools (PPAP, APQP, FMEA, 7 QC Tools). Exposure to calibration , gauging , and use of measuring instruments (Micrometers, Verniers, Profile Projector, etc.). Soft Skills: Strong leadership, communication, problem-solving, and analytical abilities.

Opening with an leading Pharma Company. Role & responsibilities : Continuous process Monitoring Batch Release of Finished product Collection of Sample ie in-process, Finished Product , Control, Stability and Tendor Knowledge of Collection of Validation samples i.e process validation, cleaning and hold time validation. Knowledge of review of Master and executed MFR/BMR and MPR/BPR Adequate knowledge of Inprocess checks of Tablet ,Capsule ,Liquid and Ointment. Adequate knowledge of Shop floor related Non-compliance ,its root cause and compliance. Adequate knowledge of calibration of instruments ie weighing balance , friabilator, DT apparatus, hardness tester, Vernier calliper, Moisture analyzer, leak test apparatus and Ph meter etc. Interested candidates shared resume on snehal@topgearconsultants.com

Role & responsibilities Job Summary We are seeking an individual for the Quality Control Microbiology team, responsible for review and approval of microbiology analytical data/record, review of EM and water trend, monitoring of aseptic process simulation. Review and approval of Analytical method validation related to Microbiological test. This role includes the participation into investigation related to Microbiology Roles & Responsibilities Responsible for Review and release of Microbiological Tests (Environmental Monitoring, Water Testing, Microbial Limit Test, Sterility Test and Bacterial Endotoxins Test). Responsible for review and Approval of Microbiological testing data/ Master data in LIMS. Handling of QMS elements like change control, Incident, OOS, OOT and CAPA related to Microbiology. Responsible to carry out the investigations related to Microbiology and timely closure of the same within the defined timeline. Review and approval of SOPs, protocols and reports related to Microbiology. Ensuring the compliance of Audit observations related to Microbiology. To review trends as applicable and to recommend any changes for the better control of the system. To review and approve STPs, Specifications, preparation of record of analysis and analytical test report. To ensure cGLP activity in lab and compliance in Microbiology laboratory. Responsible for the Monthly audit trail review of Instrument /Equipments related to microbiology. Responsible for the review and approval of Analytical method validation with respect to Microbiology. Monitoring of Media Fill/ Process Simulation and review of media fill protocols and reports. Educational qualification: A Master degree in Microbiology, or a related field. Minimum work experience : 5 to 8 years of experience in Pharmaceutical Microbiology / Quality assurance or a similar role Skills & attributes: Technical Skills • Knowledge of microbiology and aseptic practices and Aseptic Process simulation activities and disinfectant validation and handling of Microbiological Cultures. • Skilled in review of Microbiological data, EM, water and compressed air trends. • Review of EM and water trends, trends, Handling of Microbiological Culture. Behavioural Skills • Attention to detail in performing line clearance, verification, and record reviews. • Skilled in time management and coordination for sampling, testing, and execution of batch manufacturing and packing activities. • Communicates effectively with team members and stakeholders regarding batch-related activities and compliance. • Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification. • Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in manufacturing processes.

NAB is looking for Analyst to join our dynamic team and embark on a rewarding career journeyGather, analyze, and interpret complex datasets to identify trends, patterns, and insights that support strategic decision-making within the organization.Develop, maintain, and update detailed reports, dashboards, and visualizations to communicate key metrics and findings to stakeholders.Collaborate with cross-functional teams to understand business needs, translating them into data requirements and actionable insights.Conduct market research, competitor analysis, and customer behavior studies to inform business strategies and improve performance.Monitor data integrity and accuracy, implementing quality control measures to ensure reliable, consistent reporting.

Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion of training. 7. Review of Master formula and technology transfer documents for API sites. 8. Master product label information update in Traces application as per the site requirement. 9. To provide training of SOPs, cGMP, or other modules as per the requirement. 10. Review of SOPs related to various departments of corporate functions (e.g. CPRL, PAN Lab, HR etc). 11. Scheduling and participation in self-audits (Sites and corporate functions). 12. Regulatory and customer audit support to sites. 13. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites in DocuSign. Master and making effective through DocuSign and distribution of controlled copies to site and CFTs. 14. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. 15. Participation in Quality related meetings. 16. Shall perform any other related work/projects assigned by CQA HOD/Section head.

1.Having good knowledge about maintenance basic concepts about MTTR , MTBF , technical knowledge about pharma equipments.

Job Summary We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards. " Roles & Responsibilities You will be responsible for executing or assigning in-process activities during shifts, conducting line clearances, material verification, overseeing start-up of machines, and coordinating sampling activities to ensure product quality and compliance. You will be responsible for executing or assigning the execution of batch records and log books, filling in various applicable formats, including line clearance and sampling formats, along with batch records review sheets. Your tasks also involve reviewing the records maintained by the Production team, creating additional records as needed, conducting all documentation with respect to Quality Assurance (QA) activities, ensuring that documentation is happening online, and follow the incident reporting system in the case of deviations. You will be responsible for issuance, availability, and adherence of approved procedures to the manufacturing team. You will be tasked with checking the adherence to the Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions) management on the shop floor. Your responsibilities also include verifying whether the manufacturing facility meets basic Good Manufacturing Practice (GMP) requirements at all times, including facility upkeep, environmental conditions, segregation of materials, and status labeling. In case of deviations, you will follow the incident management process. You will provide essential support to the supervisor in conducting investigations related to complaints, batch failures, Out-of-Specification/Out-of-Trend (OOS/OOT) results, incidents, etc. by collating data and conducting interviews. You will coordinate with cross-functional teams to facilitate and drive the investigation process, conduct a thorough root cause analysis, document CAPA, verify implementation within the agreed timeline, and monitor its effectiveness over time. You will be responsible for supporting or assigning personnel to assist in internal and external audit activities, following the instructions of superiors, providing necessary information, documents, and clarifications to supervisors during actual audits, and maintaining appropriate records. You will follow up with respective user departments to share audit responses and diligently track and maintain the closure of action items arising from audits as needed. " Qualification Educational Qualification A B.Pharm. or Post-Graduation (Life Sciences) Minimum Work Experience 4 years of industrial experience with specific operational experience in Manufacturing, Quality Control, Quality Assurance or Engineering & Development Skills & Attributes Technical Skills: A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization. In-depth knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs. Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities. Awareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market. Comprehensive knowledge of the specific products associated with the pharmaceutical organization, including their characteristics, manufacturing processes, and quality requirements. Ability to understand and implement organizational policies and ensuring compliance. Behavioural Skills: Demonstrates a commitment to continuous learning. Strong communicating and influencing skills. Displays analytical and logical thinking abilities. Is self-motivated and takes initiative. Adaptability to the work environment, along with being a team player. Ability to go beyond boundaries, showcasing a proactive and innovative approach. " Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon... " Benefits Offered At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards... " Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions... For more details, please visit our career website at https://careers.drreddys.com/#!/ "

Implement and maintain the company’s QMS ISO 9001 Collaborate with cross-functional teams to ensure compliance with quality standardsDocumentation control and QMS records. Lead root cause analysis and resolution of quality issues and non conformances

Person should familiar with instrumentation and having working experience in DCS 800 X manufacturing ecosystem. Experience in repair and calibration of various process field DCS panels troubleshooting. Required Candidate profile Exposure in setting up testing stations for fast moving and reusable parts such as valves Should have knowledge of ISO system, documentation & possess strong analytical & communication skills. .

Job Summary We are looking for an individual for the SIT Team to oversee the investigation of major and critical deviations, working closely with Cross-Functional Team (CFT) members to identify root causes and implement corrective and preventive actions. The role involves active participation in investigating Out of Specification (OOS) cases, ensuring accurate classification in the DCMS deviations log, and providing support during regulatory inspections. Roles & Responsibilities • You will be responsible for overseeing the investigation of major and critical deviations from the outset, collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), preventive actions (PA), and preparing comprehensive reports. Your will also be working on the trending of the deviations and identification of adequate action items for reduction of the same. • Your role involves active participation in investigating OOS (Out of Specification) and other relevant cases, working closely with CFT members to determine root causes, CA, PA, and report writing. • You will review minor and critical , providing constructive feedback for improvement. • Your responsibilities include periodically assessing the trending of minor deviations, highlighting or escalating key observations, regularly reviewing the deviations log to ensure accurate classification, and utilizing the Rubrics template for crafting investigation reports. • You will offer necessary support to the site in readiness for or during regulatory inspections related to investigations. Qualification Educational qualification: A Bachelor's or Master's degree in a relevant scientific field, such as Chemistry, Biochemistry, Pharmacy, or related discipline Minimum work experience : 7 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance Skills & attributes: Technical Skills • In-depth knowledge and experience in overseeing investigations, and familiarity with root cause analysis, corrective actions (CA), and preventive actions (PA). • Expertise in investigating valid OOS and other relevant cases. • Familiarity with reviewing deviations / OOS log and ability to perform classification of data. • Ability to craft comprehensive investigation reports. • Experience in providing necessary support for regulatory inspections related to investigations. • Knowledge of regulatory requirements pertaining to deviations investigations. Behavioural Skills • Ability to collaborate closely with CFT members. • Analytical mind set for identifying root causes and developing effective solutions. • Strong problem-solving skills and attention to detail in reviewing deviations, reports, and trending data and implementing corrective actions. • Effective communication skills for report writing and escalation of key observations. • Commitment to ensuring compliance with regulatory requirements in investigations. • Ability to offer necessary support to the site in readiness for or during regulatory inspections. Additional Information looking someone with strong QC Microbiological investigation background. Should have exp in Microbiological compliance. Education :M.Sc. Microbiology Exp : 8-10 Years Industry : Injectable preferred/ OSD will be second preference Person will be responsible to manage 3 sites Microbiological compliance at Baddi

Experience: 7 to 14 years in Engineering for Automation and 21 CFR for Manufacturing Equipment Qualification: BE/B.Tech Designation- Senior Executive to Assistant Manager Level What is 21CFR Automation? 21 CFR Part 11 is an FDA regulation that defines the criteria under which electronic records and signatures are considered reliable and equivalent to paper. Roles involving 21CFR automation engineering typically lie at the intersection of automation, computer system validation (CSV), GMP compliance, and process control. Key Responsibilities: System Design & Integration Design , program , test , and implement automated systems (PLCs, SCADA) for manufacturing or laboratory use, ensuring they support FDA-regulated processes Validation & Compliance Develop and execute validation documentation including URS, FS, DSand protocols such as IQ, OQ, and PQ, all aligned with 21CFR Part 11, cGMP, and GAMP standards Ensure compliance with data integrity, user security, disaster recovery , and system backup provisions per Part 11 Support & Troubleshooting Provide day-to-day operational support , including on-call troubleshooting for upstream/downstream manufacturing systems Lead rootcause analyses for system failures and corrective/preventive action (CAPA) activities Documentation & Audit Readiness Document processes, software versions, maintenance logs, and validation reports to maintain audit trails Support audits ; act as subject-matter expert for internal and regulatory inspections Cross-Functional Leadership Collaborate with process engineers, QA, IT, production , and external vendors to align automation with operational and compliance requirements . Drive continuous improvement through smart manufacturing Cybersecurity & Regulatory Controls Maintain enterprise-level cyber resiliency , including OS patching, control system security, and user access compliance Key Skills and Competencies: Hands-on experience with 21 CFR and Automation in Engineering for OSD/Injectable Facility area equipment. Good knowledge of cGMP Hands on Technical exposure on PLCs,SCADA,HMI System specs, trace matrices, IQ/OQ/PQ, CSV per 21CFR Part 11 and cGMP Deep knowledge of FDA regulations (Part 11, data integrity, cyber security compliance) Troubleshooting, CAPA, on-site support, SOP development Role & responsibilities Preferred candidate profile

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. 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Overseeing the quality assurance function at our manufacturing sites located in Baddi & Rudrapur. Ensure that all products manufactured at the sites adhere to the required quality standards, regulatory requirements, and internal procedures. Required Candidate profile M.Sc/B.Pharm/M.Pharm 12+ year QA experience in a regulated pharma/CDMO environment Strong knowledge of cGMP, ICH & regulatory guidelines Hands-on experience in audits, documentation, quality systems

*Develop, implement, and monitor quality assurance policies and procedures for manufacturing. *Conduct inspections, testing, and audits at various stages of production to ensure adherence to quality standards and specifications. Required Candidate profile *Oversee after sales service operations, including installation support, troubleshooting, and maintenance. *Manage warranty claims, spare parts inventory, and logistics for replacement parts.

Responsibilities: Conduct reliability testing & failure analysis Implement FMEA, CPk, Failure Mode Analysis Perform root cause & defect analyses Experience in electronic product/module is preferable Exp in product quality functions

Title - CAPA Engineer Location Pune experience 5+ Notice period - Immediate to 30 days QA CAPA. CAPA Quality Engineer,• Independently produces and completes CAPA records . • Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem-solving.,Additional support for CD related activity as approved by Dan Leonard for Priority 2 APEX Resource General - needed to support both ongoing CAPAs as well as CAPAs related to CD. Anticipated influx of 40-50 new CAPAs associated with CD audits. Reduces probability of us missing commitment dates for CAPs and in turn reduces financial penalties that the company has to pay.