107 Validation Jobs - Page 3

Overall responsible for all type qualification and validation activity. Overall responsible for review of documents, calibration/ validation/qualification activities. Overall responsible for Inprocess Quality Assurance, TTD / PDR review / process review. Overall responsible for Vendor Qualification / vendor questionnaire/ Material management

"Hiring Event Announcement" We are organizing a Hiring Event in Hyderabad on April 6th, 2025, for our Quality, Production and operation team of Baxter Injectable Manufacturing, Ahmedabad site. Register now for open positions mentioned below. The registration window opens until 4th April 2025. Engineering, Utility (BE/B.Tech or Diploma Electrical): 4 to 8 years experience in Injectable manufacturing plant with Utility maintenance-electrical site plant maintenance activity Engineering, Technical (BE/B.Tech or Diploma Mechanical): 4 to 8 years experience in an Injectable manufacturing plant with plant machine maintenance, preventive maintenance and breakdown maintenance activity Engineering, Instrumentation/Lab maintenance (BE/B.Tech or Diploma Instrumentation): 4 to 8 years experience in Injectable manufacturing plant with Lab maintenance, calibration, validation, Instrumentation, etc,. activity QA Batch Release (M.Pharm/M.Sc/B.Pharm /B.Sc) : 4 to 8 years experience in QA batch release, Batch record review, release document preparation, release-related compliance and cross-functional team coordination for release activity QA QMS (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 8 years experience in QA QMS team with handling of QMS element, CAPA, deviation, investigation, audit compliance, risk assessment, etc., activity QA Doc Cell (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA doc control, Batch record review, document-SOP-log book issuance and retrieval, IRA & annual product review report update, etc,. QA Validation (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA validation, thermal validation, Plant machine qualification, utility, process validation, cleaning validation, and facility qualification, QMS, etc,. QA IPQA (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA IPQA, line clearance, sampling, Batch record review, in-process quality check, QMS, batch release, etc,. QA IPQAshiftingn chargee (M.Pharm/M.Sc/B.Pharm /B.Sc) : 8 to12 years experience in QA IPQA, shift management, manpower management, QMS, line clearance, sampling, Batch record review, in-process quality check, QMS, batch release, etc,. Micro lab QMS (M.Sc/B.Sc – Microbiology/Biotechnology) : 7 to 12 years experience of micro LAB investigation – OOS, OOT, handling Deviation and CAPA, support in Audit response, SOP preparation, Etc., Micro lab reviewer (M.Sc/B.Sc – Microbiology/Biotechnology) : 7 to 12 Experience in analysis and review of Microbial analysis (BET, MLT, Sterility., etc), Validation of Microbiological analysis (Method validation), good knowledge of LIMS or similar software, prefer the experience of writing lab Investigation MFG QMS (Investigation)(M.Pharm/M.Sc/B.Pharm /B.Sc): 6 to 12 Experience in QA QMS team with expertise in handling of investigation, shop floor compliance, QMS elements, CAPA, deviation, investigation, audit compliance, risk assessment, etc., activity MFG Production (M.Pharm/M.Sc/B.Pharm /B.Sc): 3 to 8 Experience in Injectable production, mixing(batch manufacturing), filling, dispensing, sterilization, autoclave, batch record review etc., activity MFG Packing (M.Pharm/M.Sc/B.Pharm /B.Sc): 3 to 8 Experience in Injectable packing activity. automatic visual inspection machine operation, kit preparation, VIT operator training & qualification, batch record review, etc., activity Date & Time : 6th April 2025 || 09 AM to 2 PM IST Venue : Radisson Hyderabad Hitec City, Hyderabad Registration Link copy : https://talentcommunity.baxter.com/flows/india-ptqmwtvye EEO (Equal Employment Opportunity) This is where Baxter International Inc. is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

Looking for an experienced professional in Analytical Method Validation, Verification & Transfer. Must have hands-on experience with HPLC, GC, IC Dissolution, Osmometry, Leak Test Apparatus, KF Autotitrators & UV-visible Spectrophotometers.

Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA team To approve SMF, VMP, quality manual and validation protocol. To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement. To arrange management review meeting and escalate the outcome of quarterly report to management. To handle the Market Complaints and to participate in Product Recall. To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Market Complaints, product recalls and Returned goods. Responsible for review and approval of new as well as revised related Specification, Standard Test Procedure and Analytical Work Record. Responsible to design validation/ qualification strategies Responsible for validation /qualification of processing equipments, cleaning equipments and testing equipments on time. Responsible for day-to-day validation planning and execution activity. Responsible to approve specifications, standard test procedures and analytical work records. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. Responsible for regulatory & customer audits preparation, execution and its compliance. To approve and authorize technical agreements from customer and outside party. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. To ensure the implementation of quality risk management procedures. Responsible to finalize training topics as per requirement and organize annual training plan with Training coordinator on cGMP and technical aspects. To ensure that processes needed for the Quality Management System are established, implemented and maintained. Responsible for investigation & review of non-conforming events including customer complaints and internal non-conforming events. Responsible for report, review, evaluation and tracking of change control, deviation, incident, market complaint, non-conformance report, product recall, corrective and preventive action. Responsible to ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of Quality Management System. Responsible to perform vendor audits and internal audits. To check audit trial and back-up verification documents. Participation in study raised through Quality Management System.

Handling of Equipment Qualification, Area Validation, Process validation, cleaning validation, Risk assessment, Change control, Deviation, HVAC validation please share your profile & contact: Call: 8160615349/7878051751

We are looking for a seasoned Quality Assurance Head to champion quality and compliance at Reputed Pharmaceutical Company, ensuring the highest standards in pharmaceutical manufacturing. As QA Head, you will spearhead the establishment and maintenance of robust Quality Management Systems (QMS) aligned with global regulatory standards (EU GMP, US FDA, MHRA, WHO). Your leadership will be pivotal in managing internal and external audits, driving CAPA implementation, and overseeing deviation investigations to maintain product integrity. The ideal candidate will possess a deep understanding of cGMP, ICH guidelines, and QbD principles, coupled with exceptional leadership and communication skills. You will play a critical role in ensuring regulatory compliance, managing supplier quality, and fostering a culture of continuous improvement within the QA team. You will ensure compliance with cGMP, GLP, GDP guidelines, batch release and documentation, and also lead regulatory inspections. If you are passionate about quality, possess a strategic mindset, and thrive in a dynamic pharmaceutical environment, we encourage you to apply and lead Evertogen towards excellence in quality assurance. Job Details: Industry: Pharmaceutical Department: Quality Assurance Role: Quality Assurance Head Location: Jadcherla Compensation: Up to 30,00,000/Annum Experience: Above 15 Years Employment Type: Full-time Qualification: Bachelor's/ Master's in Pharmacy or Chemistry Responsibilities: Quality Systems & Compliance Establish, implement, and maintain a robust Quality Management System (QMS) compliant with EU GMP, US FDA, MHRA, WHO, and other relevant regulatory requirements. Oversee the development, review, and approval of Standard Operating Procedures (SOPs) and other quality-related documentation. Lead and manage internal audits to assess compliance with cGMP guidelines and identify areas for improvement. Ensure adherence to data integrity principles and practices across all quality-related activities. Represent the company during regulatory inspections and customer audits, ensuring effective communication and resolution of findings. Monitor and report on key quality metrics, identifying trends and implementing corrective actions as needed. Batch Release & Documentation Review and approve Master Batch Records (MBRs), Batch Manufacturing Records (BMRs), and Batch Packaging Records (BPRs) to ensure accuracy and completeness. Oversee the timely release of batches, ensuring compliance with all applicable regulatory requirements and quality standards. Manage the documentation control system, ensuring proper storage, retrieval, and archival of quality records. Ensure all documentation is in compliance with cGMP principles and regulatory guidelines. Collaborate with production and other departments to resolve any issues related to batch documentation or release. Implement and maintain systems to track and trend batch release metrics, identifying areas for improvement. Deviation, CAPA & Change Control Lead investigations into deviations, out-of-specification (OOS) results, and out-of-trend (OOT) results, identifying root causes and implementing corrective actions. Manage the Corrective and Preventive Action (CAPA) system, ensuring timely and effective resolution of quality issues. Review and approve change control requests, assessing the potential impact on product quality and regulatory compliance. Monitor the effectiveness of CAPA plans and change control implementations, ensuring that they achieve the desired results. Collaborate with cross-functional teams to identify and implement preventive actions to minimize the risk of future deviations. Ensure all deviations, CAPAs, and change controls are documented and tracked in accordance with company procedures. Regulatory & Customer Audits Serve as the primary point of contact for regulatory agencies during inspections, managing the audit process and responding to inquiries. Lead the preparation for and conduct of customer audits, ensuring compliance with client requirements and expectations. Review and approve responses to regulatory observations, audit findings, and market complaints, ensuring timely and effective resolution. Maintain up-to-date knowledge of regulatory requirements and industry best practices, ensuring that the company remains in compliance. Develop and implement strategies to improve the company's audit readiness and overall compliance posture. Establish and maintain strong relationships with regulatory agencies and customers. Supplier & Vendor Qualification Oversee the vendor qualification program, ensuring that all suppliers of raw materials, packaging materials, and contract services meet the company's quality standards. Conduct audits of suppliers and vendors, assessing their compliance with cGMP guidelines and other regulatory requirements. Review and approve supplier quality agreements, ensuring that roles and responsibilities are clearly defined. Monitor supplier performance, identifying and addressing any quality issues or concerns. Collaborate with procurement and other departments to ensure that supplier quality is a key factor in sourcing decisions. Maintain a list of approved suppliers and vendors, ensuring that all are qualified and meet the company's standards. Training & Team Management Develop and implement training programs for QA, production, and other relevant departments on cGMP, data integrity, and regulatory requirements. Lead, mentor, and develop a high-performing QA team, fostering a culture of continuous improvement and collaboration. Conduct performance reviews and provide feedback to team members, identifying areas for development and growth. Ensure that all QA personnel are properly trained and qualified to perform their assigned duties. Promote a culture of quality and compliance throughout the organization. Manage the QA budget, ensuring that resources are allocated effectively to support the company's quality goals. General Expectations and Past Experiences: Possess a Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrate 15+ years of progressive experience in Quality Assurance within the pharmaceutical industry, with a focus on sterile dosage forms. Exhibit in-depth knowledge of cGMP regulations, ICH guidelines, and global regulatory requirements (US FDA, EU GMP, MHRA, WHO). Proven ability to lead and manage a QA team, fostering a culture of collaboration, accountability, and continuous improvement. Expertise in conducting and managing regulatory inspections and customer audits. Proficiency in Quality Risk Management and the application of QbD principles. Strong problem-solving and decision-making skills, with the ability to analyze complex situations and implement effective solutions.

Bachelor’s degree in Engineering/Science and 8+ years in quality systems. Experience in Process Development, Validation, and MSA. Knowledge of FDA, ISO 13485, and Medical Device standards. quality tools skills.

Role & responsibilities Product performance assurance, Design & implement validation process & test protocols. Ensure alignment with customer requirement & regulatory standard during validation Ensure products comply with applicable regulatory department. Preparing Testing Plans , DVP, Control Plans as per Test Standards Executing Product Validations as per Design validation Plan ( DVP)and Automotive Standards within the Customer's timeframe Handling end to end Parts Homologation at ARAI Reviewing Test Reports of team, finding errors correcting them approving them for sign off Setting up Test bench, designing Test Jigs required for Inhouse testing & validation Functional, Environmental, Endurance Testing Functional: Preparing Testing Plans , DVP, Control Plans as per Test Standards Executing Product Validations as per Design validation Plan ( DVP)and Automotive Standards within the Customer's timeframe Handling end to end Parts Homologation at ARAI Reviewing Test Reports of team, finding errors correcting them approving them for sign off Setting up Test bench, designing Test Jigs required for Inhouse testing & validation Worked on DC to DC Converters, Power electronics, audio video multimedia devices, amplifiers, usb devices, analog cameras, HMI displays Functional, Environmental, Endurance Testing Behavioral: Analytical Mind Good Communication Attention to Detail Eagerness to learn and become an expert on Testing Standards Preferred candidate profile Skill: Product Testing Awareness of product testing, tools & labs required Subject matter expertise in Automotive Testing Standards for electronic components such as Vibrations, IP Water Ingress , EMI EMC, UL94 flammability, etc. Knowledge: Knowledge of materials like Plastics , Polymers & Sheet Metal types and specifications Knowledge of Electronics parts & technical Specifications

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA- Department . Position :Executive or Sr Executive Experience : 2 -8 Yrs Job Description: 1) Handling of QMS documents like Incident, change control and LER. . 2) Review of Formulation Analytical Development & Method Validation and Transfer Protocols and Reports. 3) Review of Product development with QbD approach. 4) Review of FRD Documents (LNBs, BDRs, PDRs, MFRs and MPR) 5) Preparation and Review and Approval of SOPs ,Guidelines. Responsible for conducting Internal Audits/External Audits for Cross functional Departments.Responsible for Review and Approval of Vendor Qualification Please Share me Update Resume :Careers@biophore.com Total Exp: Current CTC: Exp CTC: Notice Period: Designation:

Role & responsibilities 1. Experience in Batch Preparation. 2. Batch Filling. 3. Aseptic Maintenance. 4. Media FIll. 5. Validation. Preferred candidate profile From sterile formation injectable plant. Perks and benefits 1. Pickup and Drop Facility 2. Canteen Facility

experience in Validation activities (Equipment Qualification, Autoclave Qualification, HVAC Qualification, Smoke Studies, Cleaning Validation etc.). Plus sterile experience is required. Required Candidate profile experience in Validation activities (Equipment Qualification, Autoclave Qualification, HVAC Qualification, Smoke Studies, Cleaning Validation etc.). Plus sterile experience is required.

Role & responsibilities We are seeking a highly motivated and skilled professional in the Lead role for Tec Support team . In this role, you will be responsible for managing day to day operations, task allocation, day end closure of activities related to the team of 6 Tech Support engineers, that is growing. The tasks performed by Tech Support Engineers are: Remote Configuration/Commissioning IoT Gateway and Endpoints Remotely Onboard the gateway to cloud application through authentication mechanism Remotely Validate the data received from IOT endpoints on the gateway and cloud application Configure and troubleshoot networking equipment (routers) and Follow up with filed installation teams and vendor to ensure timely completion of IOT gateway and site onboarding to cloud application Continuous Monitoring for equipment performance and energy saving using internally developed tools and reports Planned and unplanned Updates Software, firmware and schedules You will work closely with Tech Support Engineers, Field Project Team Leads and Application Development teams. Responsibitlies: Set processes for Tech team for Commissioning, Onboarding and Validation (COV). Details of COV activities are: End point and gateway configuration, functional testing, and integration of IoT devices with third-party systems (Energy Meters, HVACs) Onboarding the gateway / remote facility to cloud using authenticated token Validation of Energy Meter data: PF, Voltage, KWH Validation of HVAC Data: Set, Return Air and Zone Temp, ON/OFF, run hours Create floor plans and commissioning documentation Application of schedules Set processes for other activities of Tech team: Configure and troubleshoot networking equipment (routers) and Continuous Monitoring for equipment performance and energy saving Planned and unplanned Updates Software, firmware and schedules Prepare summary report of COV activities Daily and monthly report of AgileWorks performance on pre-decided parameters of uptime, energy savings, alerts, etc Preferred candidate profile Technical Skills: Understanding of networking: TCP/IP, subnetting, DNS, DHCP, WiFi Network Understanding of Electrical parameters: Energy, Power, Power factor, Voltage and current Experience in IoT or SCADA monitoring Proficiency in Microsoft Excel, Outlook, PowerPoint, and Word Soft Skills: Excellent written and verbal communication skills in English. Strong problem-solving and analytical skills. Ability to work effectively in a team environment Ability to lead and motivate team Perks and benefits Competitive Salary commensurate with experience and skills. Health Insurance: You and your family. Paid Time Off: Generous paid time off policy, including vacation, sick leave, and holidays. Professional Development: through training programs and mentorship. Dynamic Work Environment: Be part of a fast-growing and innovative company Impactful Work: Contribute to a sustainable future by helping businesses optimize their energy consumption.

Roles and Responsibilities Conduct commissioning, onboarding, validation, and data validation activities for new installations. Provide technical support through remote sessions, troubleshooting issues related to IoT devices and energy monitoring systems. Ensure timely resolution of customer complaints by analyzing root causes and implementing corrective actions. Perform regular maintenance tasks such as software updates, firmware upgrades, and hardware replacements. Manage and groom team Ensure SLA timelines Skill & Knowledge : Understanding of Networking and remote support Some understanding of BMS / IoT / SCADA Proficiency in MS Office Tools Some understanding of HVAC At least 2 years experience of managing team

We have an urgent opening for Sr. Engineer - Mechanical Design Engineering position with our esteemed client manufacturing automobile parts MNC at Pune (Khed) location. Interested candidates mail your updated resume at unihr02@gmail.com 5 Days Working Subsidized company bus (Nashik Phata to Khed route) Subsidized canteen facility for lunch Qualification - Engineering graduate Experience - At least 10 years Job Description - The candidate will report to the head of Research and Development. Based on the instructions received from the manager, the candidate will have to follow the assigned activities related to the projects inherent to the industrial development of the product. Job Responsibilities 1) Reporting to the Manager at design & development of ADR India in line with the overall Product roadmap of the department 2) Support the manager to develop ADRI strategy in alignment with customer requirement, regulations, cost, quality (durability/reliability), time, emerging trends in technology, RFE (Rational/Functional/Emotional) 3) Help the manager to identify opportunities for standardization of design and parts across programs in co- ordination with the procurement, quality, and production management teams 4) You will support design manager and the team to meet project milestones and completes projects within the established timeline. Additionally, you will need to help the manager to evaluate issues, provide resolution. 5) Your responsibility includes providing input to strategic decisions that affect the functional area of your responsibility 6) You are expected to resolve escalated issues arising from operations and requiring coordination with other departments 7) Carry out projects relating to components or products with the aim of creating producible samples. 8) Carry out modelling and detailed drawing of the components with 3D CAD software (Autodesk Inventor). 9) Use and implement spreadsheets to verify the designed parts. 10) Carry out functional kinematic or structural simulations (FEA) of the designed parts. 11) Plan and organize the progress of the projects under his/her responsibility, interfacing and collaborating with colleagues from other company departments. 12) Manage, also preparing in person, the documentation necessary for the activities related to production. 13) Collaborate and discuss with the foreign technical staff of the group regarding the technical production aspects inherent to the developed products. 14) Interface with the Purchasing Office in order to monitor the suppliers suitable for the production of the material necessary for the scheduled tests, providing any technical support. 15) Define the testing methods necessary for product validation. 16) Create and/or collaborate with the Technical Offices of the group for the drafting of the technical documentation necessary for the implementation of the projects and for the production orders. 17) Coordinate with Production and Logistics to ensure the availability of the production lines for the execution of the validation tests. 18) Supervise the progress of the activities under his responsibility, verifying that the necessary technical and quality standards are maintained during the various production phases. 19) If requested, monitor the costs relating to the testing activities, checking that the budgets established for each phase are respected. 20) Provide documentation of all the phases of progress of the research and development activities. 21) Interact and collaborate with the functions related to the job within the company and it's subsidiaries. 22) Participate in progress meetings of the activities under his/her responsibility, personally presenting the results of the results achieved. 23) Draft the documentation required for Research and Development activities and report to the direct manager. 24) Ensure the achievement of the project KPIs. 25) The ideal candidate has a degree in Mechanical Engineering and has gained at least 5 years of experience in the R&D or design area within industrial metal working production companies. Has a strong foundation in mechanical design and verification according to both international standards and engineering calculation methods. 26) Has mastery of mechanical technical drawing, the mechanical behaviour of materials (in particular steels), and processing tolerances. 27) Has knowledge of traditional mechanical processes and technologies (chip removal, carpentry processing, melding, welding) and may have also deepened his/her professional experience in other industrial fields. 28) Experience in using a PC is required, with in-depth knowledge of 3D modelling software, in particular Autodesk Inventor, and the Office package. 29) The person sought is open to discussions and loves to share different points of view useful for the growth of the company, also bringing innovative ideas. 30) He is able to work in a challenging environment, operating simultaneously on more than one activity. 31) Therefore, the profile of the ideal candidate is completed by: good communication and relationship skills, flexibility of thought, leadership skills and a strong orientation to achieving.

Position Summary The Senior Thermal Engineer will be responsible for leading the design, analysis, and optimization of thermal systems and solutions. The ideal candidate will have extensive experience in thermal engineering, a deep understanding of advanced optoelectronic systems, and a proven ability to deliver innovative solutions to complex thermal challenges. Key Responsibilities Design and Analysis Perform Failure Mode and Effects Analysis (FMEA) on potential designs to identify and mitigate risks. Develop innovative thermal solutions for advanced optoelectronic systems and components. Create solid and production-level drawings and models for thermal designs. Testing and Validation Conduct thermal measurements to certify and enhance thermal solutions and validate models. Analyze performance data and iterate on designs to optimize efficiency and reliability. New Product Development Develop new product platforms in collaboration with operations and manufacturing professionals to meet cycle time, yield, and cost requirements. Work closely with cross-functional teams to ensure product performance aligns with customer and market needs. Manufacturing and Assembly Develop and document procedures for the assembly of thermal solutions. Provide support to manufacturing teams, ensuring seamless integration of thermal designs into production. Vendor and Inventory Management Work with vendors to complete specifications for thermal components and systems. Assist with part inventory management and create purchase requisitions as required. Process Improvement Analyze existing processes and suggest innovative thermal solutions to enhance efficiency and reduce costs. Stay updated with industry advancements and incorporate new technologies into designs and processes. Qualifications & Skills • Education: Bachelors or Masters degree in Mechanical Engineering, Thermal Engineering, or a related field. • Experience: 15-25 years of experience in thermal engineering, with a focus on advanced systems and components. • Strong expertise in FMEA, thermal measurements, and thermal modeling. • Proficient in CAD software and thermal simulation tools. • In-depth understanding of manufacturing processes and assembly techniques for thermal systems. • Demonstrated ability to work with cross-functional teams and external vendors. • Excellent problem-solving skills with a focus on innovation and efficiency. • Strong communication and documentation skills.

Greetings from HCL! Currently Hiring for "Validation" JD: Computer System Validation (CSV) Good Documentation Practices (GDP) Regulatory Compliance (GxP, FDA 21 CFR Part 11, EU Annex 11) Risk Assessment & Management & SDLC Experience - 7-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com

Looking for an HiL Expert to handle 20+ team, who is dynamic decision maker and good in team handling and customer handling. Project Leadership & Execution Drive and oversee ADAS HIL testing projects, ensuring timely delivery of milestones. Define project goals, scope, timelines, and deliverables in alignment with business objectives. Collaborate with cross-functional teams including development, validation, and OEMs/suppliers to ensure smooth project execution. Team Management & Leadership Lead and mentor a team of HIL test engineers, providing technical guidance and performance feedback. Allocate resources efficiently to maximize team productivity and meet project deadlines. Foster a collaborative and innovative work environment within the team. Excellent team leadership, stakeholder management, and communication skills. KPI & Performance Monitoring Define and track Key Performance Indicators (KPIs) for project success, such as test coverage, defect detection rates, and validation efficiency. Monitor project progress, identify risks, and implement mitigation strategies to keep projects on track. Prepare and present status reports, test results, and quality metrics to stakeholders. Technical Expertise & Innovation Oversee HIL test bench setup, automation, and execution for ADAS feature validation. Ensure adherence to industry standards (ISO 26262, ASPICE) and best practices in testing methodologies. Drive test automation improvements using tools like EXAM , dSPACE , or Vector tools to enhance efficiency GERMAN language is must 10+ years of experience in ADAS/Powertrain testing, HIL validation, or automotive test management.

JOB RESPONSIBILITIES : [A] Regulatory Compliance : 1. To co-ordinate with corporate regulatory department for submission of documents as part of filing of DMF, updating and response to queries to US, Europe, China, Japan, Korea and Rest of World market. 2. To co-ordinate with various department for the timely submission of documents and its compliance. 3. Coordination with quality control, analytical development lab (ADL) and corporate validation Lab (CVL) for specification and standard test procedures. 4. Coordination with CQA for document preparation and implementation. 5. Keep the track of technology/Analytical Method transfer and other documents received from ADL and R&D. 6. Responsible for co-ordination during regulatory inspections and customer audits. Responsible for co-ordination with all stake holders for appropriate action plans for the corrective and preventive actions (CAPA) and timely closure. 7. Review and approval of stability summary report and handling of stability failures. Responsible for timely communication with corporate regulatory department on the stability failures for further actions with regulatory agencies and customers. 8. Responsible for the co-ordination with QC and other agencies for the timely qualification of working reference standards (WRS) of APIs, intermediates and impurities. 9. Responsible for the management of Skip Testing and associated documents. 10. Responsible for ensuring compliance of products against monograph specification. 11. Review and approval of analytical raw data before the regulatory submissions for filing. [B] Validation. 1. Responsible for review and approved of Process Performance Qualification protocols and reports through Documentum system. 2. Responsible for review and approved Cleaning Validation and Verification protocol and report through Documentum system. 3. Ensure compliance of validation master plan. A. Batch release and Dispatch: 1. Responsible for batch release, Certificate of analysis and material dispatch related activities. 2. Responsible to communicate the business development and PPIC in case of any delays in the dispatches due to any reasons. B. QMS: 1. Responsible for Handling of Market complaint, returned goods and Recall activities. C. Product review: 1. To ensure preparation, review & approval of Annual Product Quality Review (APQR) as per scheduled timelines in coordination with other departments. D. Audit and Compliance: 1. Responsible for audit preparation, compliance and response to regulatory and customer. 2. Responsible for Retain sample management of APIs & Saleable Intermediates. 3. Perform internal audits within Alembic site. E. Customer Support/ Compliance: 1. Co-ordinate with Production, QC, supply chain, logistic, purchase and Marketing department for dispatch related activities and customer queries. 2. To support the business development team during the development of new customers by providing required information as part of questionnaire assessment and Technical quality agreement. 3. Coordination with quality control for specification, standard test procedures and QC related queries generated by customers. 4. Handling of CAPA & Change control activities for implementation, monitoring and assessment. 5. Review and approval of documents in DCS/Documentum. 6. Any other task assigned by QA Head.

Hiring Registered Nurses at Kengeri Global Village (20 KM zone) with 1-year bedside experience in ICU, Casualty, or Surgery (Neonatal not considered). Skills: Claims validation, documentation. Apply: Lavanya.p@vipsasolutions.com Call:9361445614

To prepare and review Validation Master Plan QMP, VMP, PVMP, Handling and storage of all quality document like BMR, investigation. Support the IPQA and QMS for In-Process activity Monitoring of PPQ, requalification activities

Role & responsibilities Has Experience of Validation process . Experience of Process Validation Experience of Cleaning Validation Hands on experience of Creating and reviewing Protocol for Validation Preferred candidate profile Profile - Validation Total Experience - 3+ to 5 Yrs Qualification - Msc Chemistry

Role & responsibilities 1. Prepare the validation schedules for new projects, revalidation schedules for existing equipment/utilities as per respective procedures 2. Execute and review of all the qualification/re-qualification protocols and reports pertaining to equipment, utilities, instruments and facilities 3. Responsible to update or review Qualification, Production and engineering related procedures which are compliant to current GXP regulatory norms 4. Responsible for preparation of Validation master plan/Site master file Responsible for reviewing and ensuring all the scheduled activities for Preventive maintenance, filter cleaning, filter replacements, calibrations, Alarm/audit trail reports etc are performed as per the respective procedures within specified time Preferred candidate profile B Pharmacy/Msc Education qualification with 03 to 09 years experiance Perks and benefits Best in industry

-We are looking out candidates for different sections and positions in Quality Assurance department. Such as IPQA, QMS, Lab QA, AMV QA. Interested candidates can share their resumes on a.salunkhe@v-ensure.com & n32admin@v-ensure.com Role & responsibilities 1) IPQA - In process Checks. - Line clearance - Review of BMR, BPR 2) QMS - Handling and review of Change control, deviations, CAPA of different departments. - Document issuance, archival, retrieval. - Facing the Audits. 3) Lab QA & AMV QA - Managing Analytical QA activities. - Review of documents related to QC i.e. Raw material, finished products, stability. - Review of documents of Method validation, Assay. Preferred candidate profile - Candidates must have experience in Pharma formulation plant. - Must have good communication skills. - Candidates from Regulatory plant will be given preference. - Immediate joiners will be preferred. Perks and benefits Best in the industry

Position: QUALITY ASSURANCE (QA) MANAGER Description: The ideal candidate will be responsible for overseeing the quality and safety of our food products, ensuring they meet all regulatory and company standards. This role involves developing and implementing quality assurance policies, conducting regular inspections and audits such as BRCG 9 and FSSC 22000. The QA Manager will work closely with production, procurement, and QC teams to ensure that our products are safe, consistent, and of the highest quality. Verication of HACCP, validation, test methods, updating of SOP's. Preparing customer specications, COA, and other vendor related documentation. Thorough knowledge of Export documentation knowledge related to quality assurance along with CAPA & Root cause analysis. Coordinating with external laboratory testing of FG, PM, Water As per FSSAI and Organic sampling as per APEDA. This position requires a proactive approach to problem-solving and a commitment to continuous improvement. Deliver training programs for sta on quality standards, food safety and hygiene. Stay updated on industry trends and regulatory changes. Develop and implement corrective action plans. Experience: 5-8 years Education Qualification: B-tech / M-Tech Food technology / Msc Biochemistry, Biotechnology, Microbiology, Msc Food Science & Nutrition Industry Type: Agriculture/Biochemistry/Technology /Food technology (Agri-tech) Role Type: Individual Contributor Employment Type: Full Time, Permanent

Oracle CPQ Cloud module Pricing, Quotation Configuration, Product Management-Items, BOMs, and System Configuration, Document Engine and (BML), Utilities Libraries, Validation/Hiding/Constraint rules, Layout editor, Commerce layout, XML, XML-Schema.