446 Capa Jobs - Page 3

Skills: Oracle Database, Postgres, Database design Secondary Skills: Data modelling, Performance Tuning, ETL processes, Automating Backup and Purging Processes Skill Justification Database Designing, Data Modelling, and Core Component Implementation: These are fundamental skills for a DBA. Database designing involves creating the structure of the database, data modelling is about defining how data is stored, accessed, and related, and core component implementation ensures that the database is set up correctly and efficiently. Data Integration and Relational Data Modelling: Data integration is crucial for combining data from different sources into a unified view, which is essential for accurate reporting and analysis. Relational data modelling helps in organizing data into tables and defining relationships, which is a core aspect of managing relational databases. Optimization and Performance Tuning: Optimization and performance tuning are critical for ensuring that the database runs efficiently. This involves analyzing and improving query performance, indexing strategies, and resource allocation to prevent bottlenecks and ensure smooth operation. Automating Backup and Purging Processes: Automating backup and purging processes is vital for data integrity and storage management. Regular backups protect against data loss, while purging old or unnecessary data helps maintain database performance and manage storage costs.

Key Skills: Troubleshooting & Diagnostics Breakdown Maintenance Preventive maintenance Open Die Hydraulic press Electrical Maintenance (Electrical expertise preferred) Strong knowledge of Siemens PLC, Drives, HMI & programming software. Knowledge of HT power line distributions, familiar with ACB, VCB & other switchgears Root Cause Analysis, CAPA TPM ISO Documentation Requirements: 5+ years of experience in open die press service and maintenance. Electrical Engineering (Degree or Diploma). Strong understanding of open die press principles and processes. Excellent communication and interpersonal skills. Ability to work both independently and as part of a team. Proficiency in HANA (SAP) & computer software. Job Description: Ensure Uninterrupted Power Supply to plant Planning & scheduling of preventive maintenance, predictive maintenance. Daily energy consumption monitoring & record keeping. Daily manpower planning according to work. Compile data and write reports regarding daily breakdowns. Taking care of stock inventory & maintenance cost. Prepare specifications for purchase of materials and equipment. Daily follow up with purchase team for spares & service. Develop alternate spare for any critical spare. Kaizen implementation. Taking care of machine TPM. Maintaining break down spare & Responsibility for Indents, Reservation, Notification, Service entry sheet, all works doing in SAP system. Preparing & maintaining calibration reports of instruments. Maintaining MTTR, MTBF & B/D targets in limit set by managements. Maintaining ISO documents & records. Planning shutdown of major equipment after discussing with production department. Taking care of service related issues of concern departments. Train subordinates & maintain proper communication among departments Ensure the work should be according to SOPs Ensure that subordinates should follow safety rules & regulation. Minimize absenteeism. Preparing manpower shift schedule according to work load. Take careful attention towards safety & housekeeping related to m/c area. To perform additional tasks as desired by the management Functional knowledge of Open die forging machinery, Furnaces, EOT Cranes Peeling machines, compressors Hands on Siemens PLC, Drives & Programming software, Instrumentation Knowledge of HT power line distributions, familiar with ACB, VCB & other switchgears

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. Assist in reviewing batch records and supporting batch release activities. Coordinate with warehousing for approved and rejected batch segregation. Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, or relevant field. 13 years of experience in QA or QC, preferably in formulations or oral solid dosage manufacturing. Key Skills: Good understanding of cGMP, GDP, and regulatory compliance (USFDA, WHO, MHRA, etc.). Knowledge of production processes and quality checkpoints. Strong documentation, observation, and communication skills. Familiarity with QMS tools like deviation, change control, and CAPA (optional but preferred). Ability to work in shifts and in a fast-paced environment.

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. Assist in reviewing batch records and supporting batch release activities. Coordinate with warehousing for approved and rejected batch segregation. Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, or relevant field. 13 years of experience in QA or QC, preferably in formulations or oral solid dosage manufacturing. Key Skills: Good understanding of cGMP, GDP, and regulatory compliance (USFDA, WHO, MHRA, etc.). Knowledge of production processes and quality checkpoints. Strong documentation, observation, and communication skills. Familiarity with QMS tools like deviation, change control, and CAPA (optional but preferred). Ability to work in shifts and in a fast-paced environment.

EDUCATIONAL QUALIFICATION Diploma - Electrical MINIMUM YEARS OF EXP – 3 to 7 Years NATURE OF EXPERIENCE Experience of working in continuous process industry and shifts. Good technical knowledge of process industry electrical equipment’s. Good knowledge in trouble shooting Knowledge in Industrial Safety, 5S, ISO Systems Knowledge on Electrical Maintenance activities Knowledge about earthing concepts and basic operation of AC Drives/ Servo Control, PLCs, SCADA SPECIFIC SKILLS/PERSONAL ATTRIBUTES Pro-active, result-oriented and possess analytical skills Detail Oriented Manpower management. Team Player Emergency handling & Crisis management Problem Solving attitude Working with cross-functional ability JOB RESPONSIBILITIES: Responsible for maintenance and operation of electrical system and equipment’s. Operation and maintenance of switchyard, HT & LT switchgears, equipment’s like SF6, transformer, motors, EOT cranes, battery, battery charge & UPS. Maintenance and operation of HT and LT equipment like motor, transformer, crane, battery, battery charger, UPS. Maintenance and troubleshooting of Starters -DOL, Start Delta, Auto Transformer starters / Soft Starters, Variable speed drives Maintenance of Gensets, Electrical panels etc., Implementing of planned, preventive & predictive maintenance practices to optimize machines availability with constant endeavors to realize ZERO downtime Planning spare parts & consumables for un-interrupted working of the machines Breakdown analysis and CAPA Develop Corrective and Preventive actions of repeated equipment failures Adhering PM schedules Knowledge of LOTO, work permit and ensuring 100% compliance Maintaining 5S in the area Champion and implement safe working in his area Contributing to the WCM Culture through various activities & TEI initiatives Role & responsibilities Preferred candidate profile

Quality Assurance Engineer Job Title : Quality Assurance Engineer Location : Chennai, Hyderabad, Bangalore Experience : 0-2 Responsibilities : Design, implement, and monitorquality control systems and inspection proceduresto ensure product compliance with specifications and standards. Conductin-process and final product inspections, using tools such as calipers, micrometers, and CMMs. Leadroot cause analysis and corrective/preventive actions (CAPA)for quality issues and customer complaints. Collaborate with cross-functional teams to supportAPQP, PPAP, and FMEAactivities during new product development. Maintain and updatequality documentation, including control plans, inspection reports, and audit findings. Ensure compliance withISO 9001, IATF 16949, and other relevant industry standards. Skills Required: * In-depth knowledge ofquality management systems and standards(ISO/TS, IATF). * Experience withinspection tools, statistical process control (SPC), and quality software. * Strongattention to detail, analytical thinking, and documentation skills. * Ability to work collaboratively withproduction, engineering, and supplier teams.

: Job Title Regulatory Filtering Analyst LocationJaipur, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitting regulatory applications such as permits, licenses, certificates and authorization required by governmental agencies Coordinating government interactions and compliance activities; and interacts with regulatory agencies What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Support the RTB team lead in protecting DB from legal, regulatory and reputational risk with regard to business involving sanctioned entities and / or countries. Ensure diligent review and confirmation of transactions that require escalation to a Level 2 investigator and decide on these in full compliance with the applicable Sanctions regulations and the banks policies and procedures. Execute internal control checks as defined in the KOP documentation and Embargo control framework documents governed by AFC Sanction & Embargo. Support any applicable reporting obligations to the competent authorities with respect to transaction handling. Convert timely the update of the relevant embargo lists in respective filtering systems implement the data to central and decentralized tools in GT and Operations. Support CoC Regulatory Filtering team on the adoption of new clients Your Key Accountabilities RTB focus Primarily review stopped messages and take a decision on them (either pass or investigate), based on limited set of rules provided and maintained by AFC. Record rationale for decision from pre-defined set of options. Seek feedback from more senior investigators/reviewers, where their decisions fail the four-eye control. Provide support feedback loop and filter optimization by identifying repeat mismatches to propose Good Guys. Use user access privileges only for authorised purposes; actively safeguard sensitive and confidential information. CTB focus Supports TSMO / AFC related change projects Supports remediation actions owned by TSMO / AFC Training & Development Participate Trainings such as on HotScan, Sanctions policies, L1 procedures, specific payment types, including structure / form of messages. Your skills and experience Sanctions and Regulatory Filtering SWIFT Message Format and Fields SWIFT Payment Flow SEPA Message Structure and Payment Flow MS Office (MS Excel, Word and Outlook) Proficient in e mail communication Good communication skills (Written & Verbal) Ability to support rotational shifts Ready to support on weekends How well support you

Responsibilities: Responsible for supplier & product development of wind farm site WTG lifting and assembly tools involving mechanical, hydraulic, and electrical systems for operator effort reduction Manage supplier quality across life cycle management and resolve issues in a timely manner Handle global/regional suppliers and address defects/issues using quality tools such as 8D/CAPA and process claims based on Envision procedures Collaborate with the product development quality engineering team to identify potential risks and implement mitigation plans Introduce and qualify best-fit new suppliers according to Envision quality requirements for both Indian and international business Manage supplier-driven design or engineering changes to meet Envision's specifications Perform regular product, process, and system audits at supplier sites based on annual plans and during new supplier introductions Act as a supplier process specialist to optimize and standardize processes for stable and consistent quality Requirements: Bachelor's degree in Mechanical Engineering 1012 years experience in supplier quality and development, continuous improvement, or quality assurance 25 years experience in the wind sector (preferred), especially with WTG lifting and assembly of nacelle, hub, blade, and tower, or equivalent heavy industries Mastery of core quality tools: APQP, PPAP, SPC, MSA, FMEA, Control Plan, 8D, CAPA, NC/Claim Management Experience in international MNC environments, especially with supplier quality management Strong results orientation with a proactive attitude Eagerness to learn, adapt, and tackle new challenges Multicultural working experience in Asian and European environments preferred

Knowledge in quality documentation quality plans PPAP Documents MSA, SPC, Etc. Should have exposure in QMS 9001, EMS-14001, Welding standards -15085,3834. Should conduct process audit, Product audit internal audit & MRM & report to management. Having Good Exposure in customer Complaints Handling & Corrective and Preventive Actions. All In-house rejection analysis and taking CAPA. Closure of CAPA with production team IWE or IWT certificate, heavy engineering or fabrication 10+ years of experience in heavy fabrication engineering companies.

Dear candidate Hiring for the following requirements with Engineering& Manufacturing industry 1)Maintenance Head/Manager 2)Tool Crib Engineer 3)Production Engineer 4) Maintenance Engineer 5)Quality Engineer 6)CMM Engineer 1) Maintenance Manager (1 no.) (Exp- 12 to 20 yrs) (Qualification: Diploma Engg. or B.E/B.Tech) 1. Leading the Maintenance of the Machine shop (CNC Turning, VMC, HMC, Broaching, Grinding, etc.) 2. Developing and implementing maintenance strategies 3. Conducting routine maintenance checks 4. To check and attend trouble- shooting complex electrical problems and failures 5. Ordering and tracking spare parts and equipment 6. Strong understanding of Engineering principles and knowledge of CNC Turning centers, VMCs, HMCs & CNC Grinding Machines. 7. Maintaining zero B/D for the critical machines 8. Maintaining a safe working environment 9. Managing maintenance budgets 10. Maintaining documentation and records 11. Analyse data to identify trends 12. Reading & Modifying electrical drawing, ladder diagram 13. Skill in preparing Poka-yoka and introducing Interlocking 14. Exposure on Various Types of Encoder:-Incremental, Absolute 15. Preparing MIS of Maintenance Dept. 16. Up keeping of all technical drawings catalogues, and manuals 17. Knowledge on PLC 18. Performing corrective, preventive & predictive maintenance tasks to reduce the MTTR and improve MTBF 2) Tool Crib Engineer (2nos) (Exp- 2 to 5 yrs) (Qualification: Diploma Engg. or B.E/B.Tech) 1. Complete knowledge of Cutting Tools like Inserts, Drills, End mills, Reamers etc. 2. Monitoring & Maintaining Inventory Stock 3. Knowledge of setting up and arranging Tool crib 4. Should take cost reduction initiatives 5. Responsible for Issuing, receiving & delivering tools to the shop floor 6. Follow up with the Tool Suppliers for the regular & New Development Tooling 7. Knowledge of Microsoft Excel is a must 3) Production Engineer (4 nos) (Exp- 3 to 6 yrs) (Qualification: Diploma Engg. or B.E/B.Tech) 1. Meeting the daily Plan vs Actual Productions of the machine shop 2. Ensuring zero rejection on the shop floor 3. Ensuring good 5"s in the shop 4. Knowledge of CNC (Turning centre & VMC) Programming, New part setting 5. Cutting Tools & Fixtures knowledge is must 6. Rejection analysis and CAPA preparation 7. Man management skill is a must 8. Knowledge of GD&T 9. Knowledge of gauges & Instruments 10. Drawing reading MS Office knowledge 4) Maintenance Engineer (2no.) (Exp- 3 to 5 yrs) (Qualification: Diploma Engg. or B.E/B.Tech) 1. Conducting routine maintenance checks 2. To check and attend trouble- shooting complex electrical problems and failures 3. Performing corrective and preventive maintenance tasks 4. Ordering and tracking spare parts and equipment 5. Strong understanding of Engineering principles and knowledge of CNC Turning centers, VMCs, HMCs & CNC Grinding Machines. 6. Performing corrective, preventive & predictive maintenance tasks to reduce the MTTR and improve MTBF 7. Reading & Modifying electrical drawing, ladder diagram 8. Knowledge on PLC 5) Quality Engineer (1 no.) (Exp- 2 to 3 yrs) (Qualification: Diploma Engg. or B.E/B.Tech) 1. Ensuring zero rejection on the shop floor 2. Knowledge of CNC (Turning centre, VMC, HMC & Grinding) process 3. Knowledge of GD&T 4. Knowledge of gauges & Instruments 5. Drawing reading 6. MS Office knowledge 7. Quality documentary knowledge 8. In process inspection knowledge 6) CMM Engineer (2 nos) (Exp- 2 to 3 yrs) (Qualification: Diploma Engg. or B.E/B.Tech) 1. CMM operating & programming (Accurate brand machine & RDMIS software is preferred) 2. Experience of precision manufacturing industry 3. Knowledge of GD&T 4. Knowledge of gauges & Instruments 5. Drawing reading 6. MS Office knowledge Candidates can connect on 9867726714/7208115895 Email: staffingfinesse09@gmail.com/finessestaffing09@gmail.com

Kindly share your resume on sv21@svmanagement.com Responsibilities: Engine assembly process/Product/Torque audit and ensure closer of NC with respective department Able to handle New Technology diesel engines Must have knowledge of Engine testing of advance technology engines as mentioned above Having capability of Engine failure analysis during engine testing Hands on experience on calculating Cp Cpk for torque joints and seal pressing joints Able to handle individual Engine assembly/testing line by own Analyzing engine failure root cause and solutions for resolution of concern Familiar with QMS system and able to maintain records and daily MIS generation Must be able to handle Internal/External customers with having good communication skills Required: B tech in Mech/Automobile with 3 to 8 years of experience Engine assembly/Testing with advance technology engines Root cause identification and problem solving COP, CpCpk, Six Sigma/QC Story English communication skills, Excel, Power Point, Presentation skills

Role Purpose The purpose o central quality analyst role is to conduct quality audits and perform analytics in different areas as defined by central quality team, supporting the project teams in ensuring higher client satisfaction Do 1. Conduct process quality audits as per plan Conduct various process audits as per guidelines and SPOs defined in QMS Prepare findings from the report and share it with the account/ project leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to bridge any skill gap due to these changes 2. Conduct analysis, report generation and process compliance in different areas like metrics office, CAG, Process Definition Ensure processes to be followed in Wipro in terms of all quality norms in the areas of project management and highlight potential risks Provide insights and process guidance to the projects as per the need Prepare timely dashboards, reports, insights and share with the central quality and delivery teams to ensure minimum client escalation From time to time highlight any critical escalations where the central quality teams intervention is required in any BU project team Automate the report generations etc to ensure minimization of non-value added tasks, ensuring maximum utilization of existing platforms and their increased adoption Deliver No. Performance Parameter Measure 1. Quality Standards Timely generation of reports, dashboards, insights to the respective team Accuracy of the data Feedback from the project teams on the insights Quality of insights shared with the team Reinvent your world.We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

Role Purpose The purpose o central quality analyst role is to conduct quality audits and perform analytics in different areas as defined by central quality team, supporting the project teams in ensuring higher client satisfaction Do 1. Conduct process quality audits as per plan Conduct various process audits as per guidelines and SPOs defined in QMS Prepare findings from the report and share it with the account/ project leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to bridge any skill gap due to these changes 2. Conduct analysis, report generation and process compliance in different areas like metrics office, CAG, Process Definition Ensure processes to be followed in Wipro in terms of all quality norms in the areas of project management and highlight potential risks Provide insights and process guidance to the projects as per the need Prepare timely dashboards, reports, insights and share with the central quality and delivery teams to ensure minimum client escalation From time to time highlight any critical escalations where the central quality teams intervention is required in any BU project team Automate the report generations etc to ensure minimization of non-value added tasks, ensuring maximum utilization of existing platforms and their increased adoption Deliver No. Performance Parameter Measure 1. Quality Standards Timely generation of reports, dashboards, insights to the respective team Accuracy of the data Feedback from the project teams on the insights Quality of insights shared with the team Reinvent your world.We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

Job Overview To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing. Competencies Plan, perform, and document Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) for raw materials, intermediates, and finished drug products. Prepare and review protocols and reports related to method validation/verification/transfer in alignment with ICH guidelines. Coordinate with R&D, AR&D, QA, RA, and manufacturing units for method transfer and troubleshooting activities. Perform routine and non-routine analysis using HPLC, UPLC, GC, UV, IR, dissolution apparatus, and other analytical instruments. Ensure timely qualification/calibration of instruments used in AMV lab. Review analytical documents like raw data, chromatograms, validation reports, SOPs, etc. Support regulatory inspections (USFDA, EU, ANVISA, WHO, etc.) and respond to queries related to AMV/AMT. Investigate OOS/OOT/Deviation/Incident related to AMV activities and provide effective CAPA. Maintain GLP and cGMP compliance across AMV operations. Experience: 4 -5 years in QC-AMV in a regulated pharmaceutical environment Responsibilities Qualifications M.Sc. (Chemistry/Analytical Chemistry) / M.Pharm

Nutrizo Advancis Healthcare Private Limited is looking for IPQA-Chemist to join our dynamic team and embark on a rewarding career journey Conduct in-process quality checks during manufacturing Ensure compliance with GMP and SOP standards Document results and report deviations Coordinate with QA and production teams

NAB is looking for Analyst to join our dynamic team and embark on a rewarding career journey Collect, analyze, and interpret data to support business decision-making and strategy development Identify trends, patterns, and insights through quantitative and qualitative research Prepare detailed reports, dashboards, and presentations for stakeholders Collaborate with cross-functional teams to understand data needs and implement solutions Ensure data integrity, maintain databases, and recommend improvements based on analytical findings Stay updated on industry trends, tools, and best practices to enhance data analysis and reporting capabilities

Dear Candidate, We are conducting walk-in drive on 27th June (Friday) for the positions in our Quality Assurance department. Job Description : Position Name: Fresher/Executive Experience - 0 -5 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Walk-in Date: 27th June 2025 (Friday) Time: 09:00 AM to 12.00 PM Chemveda is hiring for Quality Assurance Executive Position Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications and review of Analytical LNBs. 6. Review of Vendor Questionnaires and Review of Vendor qualification documents and checking external facility and vendor audits with respect to raw materials and finished products. 7. Review of new GMP projects with regard to regulatory and client compliance aspects, Scrutiny of GMP facilities and Review of GMP Certifications & all requirements applicable to the projects. 8. Review of SOPs, Specifications, Method of Analysis and Analytical test data sheet. 9. Review of Method transfer protocols and reports, Validation protocols and reports, Forced degradation data and Review of quality impacting incidents, OOS and Data corrections. 10. Lab rounds and Compliance verification and Qualification of GMP Contract Manufacturing Facilities (CMO). a. Circulation of Non-compliances b. Circulation of Non-Compliance reports to CMO 11. Circulating agenda for Internal Audits and Management review meetings, Reporting & Circulation of Non-Compliances and Suggestion of appropriate CAPAs. 12. Functional Objectives: Follow-up & review of the objectives action plan and Data collection & compilation. 13. Review of weekly and monthly reports and collecting data. 14. Monitoring of QMS activities as per ISO & Client requirements. 15. Document issuance, retrieval and archival, document control. 16. During the audits, to coordinate with the with the auditors to show and explain the documentation of quality systems & procedures. 17. Preparation quality system procedures and quality manual. 18. To prepare audit compliance reports or responses and to ensuring the successful closure of audit cycle. Interested candidates can attend walk-in drive or share their profiles to saivardhan.kothuri@chemvedals.com

Role & responsibilities Conduct comprehensive fire safety audits and gap assessments across manufacturing and industrial plants in accordance with factory safety norms. Identify critical non-compliances and recommend corrective actions through structured Corrective and Preventive Action (CAPA) plans. Prepare detailed audit reports, executive presentations, and compliance roadmaps for senior management and as well as safety committees. Conduct regular safety committee meetings and discuss on near miss activities and further scope of improvement in the shop floor. Perform field level inspections on fire suppression systems in and around the factory premises. Conduct regular trainings on general safety practices and create awareness Conduct regular mock drills and perform emergency preparedness plan and execute emergency drill to ensure the safe practice follow ups and train on deviations. Continuously monitor on near miss, minor and reportable accidents and provide suitable corrective action to prevent the same in future. Must be aware of ISO, legal requirement in terms of safety to the manufacturing industry.

Supervise day-to-day operations of the external preparation manufacturing section. Ensure proper execution of batch manufacturing processes as per Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs). Coordinate with Quality Assurance (QA), Quality Control (QC), Warehouse, and Maintenance for smooth operations. Monitor equipment calibration, cleaning, and maintenance to ensure readiness for production. Ensure proper line clearance, area cleaning, and equipment readiness before starting manufacturing operations. Review and maintain manufacturing documentation, including BMRs, logbooks, and deviation reports. Handle in-process checks and ensure process parameters are maintained within specified limits. Train and guide operators and junior staff in GMP practices and SOP adherence. Investigate deviations and support in root cause analysis and implementation of CAPA. Ensure compliance with EHS (Environment, Health, and Safety) standards within the manufacturing area.

Operate and monitor compression machines (e.g., Cadmach - ACC). Ensure smooth execution of batch production as per BMR/BPR and SOPs. Carry out in-process checks (IPC) like weight variation, hardness, thickness, friability, etc. Perform machine changeovers, cleaning, and line clearance. Maintain and update Batch Manufacturing Records (BMRs), logbooks, equipment usage logs. Adhere strictly to cGMP, GDP, and safety norms. Participate in audits (internal/external) and handle compliance requirements. Collaborate with QA, maintenance, and validation teams. Report deviations, breakdowns, and implement corrective/preventive actions (CAPA). Suggest and implement process improvements for yield and productivity.

> Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. > Desired Candidate Profile: Bachelor's or master's degree in engineering, life sciences, or a related field. A minimum of 6 years of experience in quality assurance within the medical device or pharmaceutical industry. Strong knowledge of validation processes, quality systems, and regulatory standards, such as MDD 93/42/EEC and ISO13485. Experience managing CAPA (Corrective and Preventive Action), conducting risk assessments, and handling internal/external audits. Proven ability to manage validation projects, including scheduling and team coordination. Excellent communication, organizational, and analytical skills. > Role & Responsibilities: Plan and execute validation and calibration activities according to the approved schedule, including HVAC, process, transport, sterilization, equipment qualification, and temperature mapping. Coordinate the preparation of PR, PO, material issuance, and service entries for validation-related activities. Provide training to relevant personnel on validation processes and artwork review. Review and compile validation reports from external agencies, ensuring timely approval and payment processing. Verify vendor agreements and certifications, ensuring timely renewals and regulatory compliance. Oversee and ensure the proper execution of QMS activities, including document management and software use (e.g., TrackWise). Participate in line clearance and IPQA (In-Process Quality Assurance) activities as needed. Prepare and review GMP (Good Manufacturing Practice) documents such as SOPs, protocols, and other required documents. Ensure adherence to ISO13485 standards and other relevant regulations. Collaborate with the regulatory department to provide validation and calibration documents as needed for regulatory submissions. Participate in internal and external audits, ensuring timely and accurate documentation submission. Manage PR initiation and closure in TrackWise for qualification and calibration activities. Prepare and execute equipment and utility validation documents as per schedule. > Functional Skills Required: Expertise in Quality Management Systems (QMS) and validation processes. In-depth knowledge of MDR and other relevant regulatory frameworks. Strong proficiency in CAPA management, auditing, and risk assessment. Technical expertise in process, equipment, and product validation. Ability to manage multiple validation projects and meet strict deadlines. > Behavioral Skills Required: Strong team management and leadership abilities. Excellent problem-solving and analytical skills. High attention to detail and a commitment to accuracy. Strong interpersonal and communication skills. Ability to collaborate effectively across teams and departments. A proactive approach to continuous improvement and maintaining high-quality standards. > Team Size to be Handle: Manage the team of 2-3 team members of Validation & QMS, reporting to AGM-QA. Learn more at https://www.biotechhealthcare.com. Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

Job Description: Proffered Profile: Bachelors degree (BE/B tech) with 3-5 years of experience in IT QMS Compliance Specialist ensures alignment of all IT systems, processes, and documentation with internal Quality Management Systems (QMS) and applicable regulatory standards such as GxP, ISO 9001, 21 CFR Part 11, and EU Annex 11. This role plays a key part in audit preparedness, deviation management, and maintaining consistent quality across IT operations and projects. Key Responsibilities: Develop, implement, and maintain IT quality policies, SOPs, and work instructions in accordance with QMS. Ensure compliance of IT systems with relevant regulatory requirements (GxP, 21 CFR Part 11, GDPR, etc.). Collaborate with QA, Validation, and Business teams for development, qualification, and maintenance of IT systems as per CSV and QMS guidelines. Manage QMS elements such as deviations, CAPAs, change controls, audit trails, and periodic reviews. Participate in internal/external audits; coordinate documentation, evidence, and responses. Conduct IT quality risk assessments and support necessary remediation. Maintain accurate records of compliance activities, including SOP training and validation documentation. Deliver training programs to IT teams on QMS processes and compliance awareness. Support full lifecycle management of computerized systems (planning, validation, operation, retirement). Assist with vendor qualification and assessments for IT-related services. Required Skills and Qualifications: 3 - 5 years in IT compliance/QA/validation in a regulated industry Working knowledge of ISO 9001, GAMP 5, 21 CFR Part 11, EU Annex 11 Familiar with LIMS, ERP, MES, DMS systems Strong documentation and analytical skills Good understanding of ALCOA+ and data integrity Preferred Certifications: ISO Lead Auditor, Six Sigma, or other Quality Management certifications

Date 19 Jun 2025 Location: Madhepura, BR, IN Company Alstom We create smart innovations to meet the mobility challenges oftoday and tomorrow. We design and manufacture a complete range of transportation systems, from high-speed trains to electric busesand driverless trains, as well asinfrastructure, signalling and digital mobility solutions. Joining us meansjoininga truly global community ofmore than38 900 people dedicated to solving real-world mobility challenges and achieving international projects with sustainable local impact. NETWORK & LINKS INTERNAL You will report to Warehouse Manager. You have to interact will below person/functions. External Logistics team Production Logistics Team Material Planners Quality EPUs EXTERNAL Interaction with vendors and Support team at Bengaluru Purpose of the Job Responsible for Picking & Shopfloor Operations in Warehouse. Responsible forReceiving, Verification, Put away, Dispatch. Responsible for workload &manpower planning Responsible for Order Picking, Inventory, Quality, Safety Compliance, Documentation, Equipment Operation Key Responsibilities Order Picking operation monitoring & publish the performance. Ensure proper Inventory Management Ensure Warehouse handling & Quality issues are zero. Safety Compliance to be adhered and monitored. Equipment Operational monitoring & usage availability monitoring Custodian of EHS roll out for the warehouse operations. Report out and take corrective actions for any safety deviations. Regular safety walks and waste walks (to chase waste awayfrom the unit) Lead logistics operators team of Picking area. Lean Warehousing, KAIZEN, Skill Matrix of team members Monitor SAP Picking operational metrics & its adherence. Conduct toolbox meetings to bring in the awareness of SQCD metrics of the business unit. Conduct Kaizen workshops to generate continuous improvement ideas. Daily, Weekly, Monthly MIS report out to management teams. Logistics / Plan & Manage Packing, Shipping and Outbound Transportation Logistics / Manage Inventory Accuracy & Integrity Function Internal Standards / Identify Needs & Define for Internal Standards, Define, Improve & Validate Internal Standards, Manage Internal Standards Deployment Function External Standards / Identify Needs & Define , Contribute to External Standards Definition, Improvement & Validation, Manage Impact of External Standards on Processes & Tools, Manage External Standards & Regulations Deployment Function Human Resources / Manage Jobs & Skills, Training & Qualification, Workforce, Staffing & organization. Function Performance / Collect Site or Country Monthly KPIs, Manage Site or Country Improvement Action Plan, Review Site or Country Monthly KPIs Ensure operations are executed in an environment that complies with Alstom Health, Safety and Environmental policies. Key Performance Indicators Ontime Picking - 99% AZDP Score 95% 5S at the Warehouse Picking Accuracy by 100% QUALIFICATIONS & S EDUCATION B.Tech/B.E. from any reputed university with minimum experience of 6+ years Technical Knowledge / Experience Warehouse Operations Knowledge Basic product knowledge Rolling stock manufacturing process knowledge preferred Management Reporting (MIS). Data Analysis ERP SAP (WM & MM) Module Good communication EHS Culture BehavioralCompetency Team player - to support / lead Cross Functional Team environment. Lead and coach the team continuously and mentor the reporting team. Confident and ability to articulate his thoughts. Leader with passion for the job and exhibits compassion towards the team members. Conflict resolution capability both within and external teams. IT Skills: ERP SAP (WM & MM) Module Knowledge, Power point, Excel. Location Madhepura (Bihar) An agile, inclusive and responsiblecultureis the foundation of ourcompanywhere diverse people are offered excellent opportunities to grow, learn and advanceintheir careers.We are committed toencouragingour employeesto reach their full potential,while valuing and respecting them as individuals.

Role & responsibilities To maintain the QA documents in compliance state and ensure they are all time ready for internal and external audits. Preparation and review of SOPs. To act as training coordinator and oversee implementation & compliance of training matrix. To maintain the vendor approval document. Daily issuance and retrieval of records of other departments. To maintain records of change control, deviations, CAPA, incidents logs, OOS, OOT. To prepare and maintain calibration and validation schedules of equipments as per VMP. Upkeep and follow-up for new product licenses. To prepare APR, trends. Prepare and review of BMR and analytical reports. Upkeep of retain samples and controls samples and their records. To maintain GMP in the plant and identify problem areas and report to Head-Quality. Line clearance in dispensing and production area. To perform in-process sampling, testing and document the observations. To handle IPQA activity in warehouse and production area.

15-20 yrs in quality for SS seamless pipes, incl. 5 yrs leadership role Expert in metallurgy, NDT, global standards & handling TPIs, audits, customers Job Description Strong knowledge of metallurgical processes, stainless steel grades, cold & hot finishing, and heat treatment expertise in Cold Finished Seamless Tubes Proficient in Hydro, Eddy Current, Ultrasonic, PMI, Mechanical & Chemical Testing manages quality at raw material, in-process, final product, and dispatch stages Hands-on experience with ISO 9001, PED, IBR, ISO 14001, OHSAS 18001, and related quality certifications Proven track record in conducting RCA, implementing CAPA, and handling Third Party Inspections (Lloyds, TUV, BVQI, DNV) and customer audits Strong documentation, traceability, and coordination with production, planning, and marketing to ensure quality compliance. The Successful Applicant Bachelor's Degree in Metallurgical / Mechanical / Production Engineering. And specialized quality certifications preferred. Minimum 15-20 years of relevant experience in the stainless steel seamless pipe and tube manufacturing industry, with at least 5 years in a leadership role. Strong knowledge of metallurgical processes, stainless steel grades, cold and hot finishing, heat treatment, and NDT techniques. Expertise in dealing with TPIs, global customers, and certification agencies What's on Offer A leadership opportunity in a technically advanced manufacturing environment. Long-term career growth within a reputed, innovation-led organization.