679 Capa Jobs - Page 19

Sodexo Food Solutions India Pvt. Ltd.ces is looking for MIS & Admin Assistant to join our dynamic team and embark on a rewarding career journey Oversee the design, implementation, and maintenance of the information systems, including hardware, software, and networking infrastructure Manage the database systems, including data backup and recovery, data security, and data integrity Develop and maintain procedures for managing the information systems and technology infrastructure, including disaster recovery plans, security policies, and user access controls Analyze the business processes and identify opportunities for improvement through the use of information systems and technology Collaborate with cross-functional teams, including IT, finance, and business operations, to integrate information systems and technology with other systems and processes Monitor system performance and provide technical support to end-users to ensure the smooth operation of information systems and technology Strong analytical and problem-solving skills Excellent communication and collaboration skills

Role & responsibilities Responsible for documentation related to quality system guidelines. Responsible for maintaining the Company's internal audit program (including quality) and assess improvement initiatives resulting from all Audits internal and external. Monitor activities to ensure compliance with core quality measures. Responsible to close internal and externally identified non-conformities and review the implementation of CAPA plan Represent the management for all external Quality Audits as and when required/directed Conducting the internal audits on timely basis & follow for NCs closure Responsible to visit south warehouses as per management requirement/Customer requirement and report the same to Zonal QA Mentor, QA Head and Zonal Manager Responsible to implement ISO 9001:2015 standard and ISO 13485:2016 standards at south warehouses as per business requirement and customer requirement Responsible to get ISO 9001:2015 standard /ISO 13485:2016 certificate for south warehouses as per business requirement and customer requirement To involve and lead new warehouse projects and new QMS SOPs preparation based on customer requirement and QMS requirement

We have an opening for Safety Officer profile for HO Gurgaon location- Company - IP Integrated Services Pvt. Ltd. Location - HO, Gurgaon Experience - 5 to 9 years No. of position - 1 Role & responsibilities Safety Audits & Reporting: Conduct safety audits at warehouses, identify risks, and report findings to General Management, ensuring timely resolution. Fire Safety & Emergency Preparedness: Maintain fire hydrant systems, conduct regular mock drills, and ensure daily safety briefings. Document Review & Process Compliance: Check and review safety documents, processes, and ensure SOPs are maintained and implemented effectively. Corrective & Preventive Actions (CAPA): Handle deviations in audits, provide support for CAPA implementation, and monitor closure with evidence. Regulatory & ISO Compliance: Ensure adherence to statutory regulations, assist in ISO process documentation, and implement quality management systems. Training & Awareness Programs: Develop and deliver training modules for employees, raising awareness about 5S, HIRA, and safety practices. Incident Risk Management: Analyze accidents/incidents, propose corrective actions, and track resolution while increasing risk management awareness. Audit Coordination: Lead and coordinate internal and external safety audits, ensuring high standards of performance and improvement. Equipment & PPE Management: Ensure proper identification, maintenance, and usage of Personal Protective Equipment (PPE) across sites. HSE Performance Monitoring: Track and report HSE KPIs such as safety performance, energy use, and compliance, while fostering continuous improvement. Preferred candidate profile • Graduate level of science or engineering discipline • Technical Qualification Diploma in Industrial Safety Management from the recognized institute / University • LA Course of ISO 45001 ( OHSAS ) and ISO 14001 • Attended and passed the examination in in Root Cause Analysis / Corrective Actions (RCA/CA) • Experience -5 to 8 Years • Very Good Presentation Skills • Inter-state travel • Might have to work beyond standard working hours when required • Good Communication Skills (Verbal & Written) • Industry Logistics & Supply Chain • Location Gurgaon Drop your CV at hr.recruitment@ipispl.in. Don't miss this opportunity!

Job Description: Head of Quality Experience: 15 Years or more Location: Udaipur About Macsen Drugs: Macsen Drugs is a USFDA registered, WHO-GMP certified, TGA GMP certified, and EU GMP (Written Confirmation) certified manufacturer of active pharmaceutical ingredients or bulk drugs for varied therapeutic applications like antidote, urinary antiseptic, topical antiseptic, ophthalmic diagnostic, anti-dandruff, anti-acne, and several other applications. Job Overview: We are seeking an experienced and detail-oriented individual to perform research activities as designing and conducting scientific experiments, analyzing and interpreting results, leading to significant value to the process development. Efficient contribution to the overall success of the research & development team performance according to objectives and targets set by the Management. Responsibilities: 1. Quality Assurance (QA) Develop and implement a comprehensive Quality Management System (QMS) compliant with cGMP and ICH guidelines. Review and approve quality documents such as SOPs, batch records, deviations, and CAPA reports. Ensure the site is prepared for regulatory audits and inspections from the USFDA, EMA, WHO, and other agencies. Conduct internal audits and self-inspections to maintain quality standards. 2. Quality Control (QC) Oversee laboratory operations, ensuring raw materials, intermediates, and finished products meet established quality specifications. Manage analytical method validations and stability studies. Monitor calibration and maintenance of laboratory instruments. 3. Regulatory Affairs Prepare and submit regulatory documents, including DMFs, for US and international markets. Address regulatory queries and implement corrective actions for observations from audits or inspections. Stay updated on global regulatory trends and ensure compliance with evolving requirements. 4. Production Oversight Collaborate with production teams to ensure manufacturing processes align with quality standards. Oversee cleaning and process validation for a multi-product facility to prevent cross-contamination. Troubleshoot production and analytical challenges in coordination with R&D. 5. Data Integrity and Security Ensure compliance with 21 CFR Part 11 for electronic records, signatures, and data integrity. Establish protocols for data security and governance across all quality operations. 6. Cross-Functional Coordination Work with R&D and Analytical Development Labs for seamless technology transfer and method development. Collaborate with Stores and Maintenance teams to ensure proper inventory management and equipment validation. Coordinate training programs for team members to maintain high-quality standards. 7. Leadership Lead and mentor teams across QA, QC, Regulatory, Production, and Maintenance departments. • Foster a culture of quality, accountability, and continuous improvement. 1. Educational Qualifications Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field. Additional certifications in Quality Management Systems (e.g., ISO 9001, Six Sigma) are preferred. 2. Experience Requirements Minimum 15 years of experience in API manufacturing, with at least 5 years in a leadership role managing QA, QC, and Regulatory Affairs. Proven experience in handling audits and inspections by regulatory agencies such as USFDA, EMA, WHO, or PICS. Hands-on experience in managing multi-product facilities with cleaning and process validation expertise. How to Apply: Send your updated resume to hrd@macsenlab.com

Skill required: Global V&A - Procurement Operations Designation: PPSM Specialist Qualifications: Any Graduation Years of Experience: 7 to 11 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 Responsible for managing various projects, planning, execution, and Post Merger Integration for Accentures acquired companies, this includes systems configuration, request to pay activities, policies, and processes. In this capacity, the individual will coordinate the evaluation of a target companys suppliers portfolio, collaborating with clients and offshore payables support teams to ensure all service objectives are met within required timeframes and in accordance with the internal compliance and policies.In this role, the individual will assure the integration and setup of the acquired companys suppliers to secure ongoing payments after cutover date. They will also ensure the new Accenture personnel understand and comply with Accenture Procurements Policies, Processes and Procedures and the usage of standards approved channels and tools by providing required training and pre/post integration support. What are we looking for Fluent in EnglishMinimum 3 years of experience in P2P, Finance, CMR or SAP/AribaMinimum 2 years of experience in Project Management Roles and Responsibilities: Role :Project ManagementFlexible scheduleAttention to detail.Process improvement. Strong written and verbal communication skillsWell organized.CollaborativeGood to have:Presentation Skills3rd language Qualification Any Graduation

HCLTech Walk-in Drive for Quality Analyst- 14th of June 25 Timings: 11:00AM- 2:00PM Venue: 138, 602/3, Medavakkam High Road, Elcot Sez, Sholinganallur, Chennai, Tamil Nadu 600119. JOB SUMMARY This position is responsible for the daily quality review of transactions and calls from voice staff in support of healthcare operations, overseeing quality assurance and improvement. Additionally, the position entails identifying, recommending, and implementing quality improvement programs and practices aimed at enhancing process improvement, customer experience and ensuring high-performing operation. It will be an individual contributor. KEY WORDS Quality Analyst, Good Communication, Customer feedback response handling, Agent feedback and coaching, RCA, CAPA, Quality Tools, RCM, US Healthcare. ESSENTIAL RESPONSIBILITIES : Achieve daily QA targets Review and assess transactions, including calls Provide fair, concise, and objective feedback Report findings to agents and leads for training and improvement Collaborate on quality processes and scoring techniques Timely report quality monitoring for agents Raise and resolve QA concerns promptly Coach and provide feedback to monitored personnel and supervisors Identify quality improvement opportunities using business tools Calibrate scores objectively Ensure consistency across sites and teams focusing on customer experience and performance Analyze quality data to identify root causes and recommend improvements Prepare monthly and ad hoc QA reports timely Work with leads and training team to address areas for improvement from QA results. SKILLS AND COMPETENCIES Provides regular coaching and feedback to agents Motivates employees for better results Strong communication and listening skills Capable of coaching for performance improvement Knowledgeable about the US Healthcare industry Understands healthcare provider business policies and practices Advanced interpersonal, presentation, and communication skills Effective problem-solving, decision-making, and innovative thinking Proficient in Microsoft Office. FORMAL EDUCATION AND EXPERIENCE Graduation in any stream Experience in denial management and calling. 1-2 years of experience as full time quality analyst in US Healthcare

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate 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 Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for contract conversion Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Good Communication skills and Any degree expect BE & B.TechGood Communication skills and Any degree expect BE & B.Tech Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 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 You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Ability to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Understand customer NPD process, challenges, and requirements Propose improvements and systems. Propose Digitalization roadmap. Presentations, demo, UAT, and implementation of NPD, APQP, PPAP, and FMEA software Project Management Required Candidate profile Min 2+ yrs exp in quality planning in manufacturing Knowledge of APQP, PPAP, FMEA, IATF, VDA requirements & documentation Excellent communication, confident, pleasing personality. Perks and benefits *5 days working *Medical Insurance *Gratuity

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 Ability to work well in a teamAdaptable and flexibleCommitment to qualityWritten and verbal communicationAgility for quick learningNA 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

We are looking for IQC Engineer at Nipro India Corporation Pvt Ltd. Qualification: DME/BE/M.Sc Chemistry/B.Pharmacy Experience : Minimum 3-5 Years Roles & Responsibilities: 1. Responsible for in process quality activities. 2. Control and solve daily quality problems in daily routine IQC activity. 3. CAPA for prevention of recurrence of complaints non confirmities and in - process non confirmities. 4. Follow up of CAPA 5. Accountable for the rework and rejection analysis 6. Control to follow up the SOP's and cGMP regulations in the working areas. 7. Find out or implement the new method or the way to improve quality of product. 8. Support to concern department for process control and set meeting to resolve the issue. 9. Training to subordinates about in process quality control 10. Prepare the report for quality meeting. 11. Preparation, Review and Updating of limit sample. 12. Support to Engineering and QAD department for calibration of all instruments in the section. 13. Establish, Review and Revise documents and quality record in section to update and follow the ISO. 14. Represent superior to join the meeting or co-ordinate inside and outside section in case he / she absent. 15. Responsible & completion of additional activity and task given by the section Head. 16. Responsible for reviewing of the artwork as per regulatory requirements. 17. Label printing and controlling 18. Rejection trend analysis. 19. Complaint Analysis. 20. Machine wise observation to contract defect. 21. Improvement on machine related to quality of production. 22. Monthly report at quality data objective 23. In process quality testing as well as controlling. 24. Label Printing and controlling 25. Monthly training of SOP to department employees. 26. Problem analysis and corrective action taken. 27. Material testing & Release in SOP system. 28. Manpower control. 29. Continuous improvement 5S & Kaizen 30. Responsible for reviewing and submitting of product DHR to quality department. Interested candidates kindly share your resume on shrawani.kadam@niproindia.com with mentioned subject "IQC Engineer - Your Name".

Position Title: QMS Manager / Management Representative (MR) Company Name: Senwell Exports Private Limited Industry: Aerospace / Precision Component Manufacturing Location: Kesnand, Wagholi, Pune Experience Required: 8 to 12 Years Job Description Senwell Exports Private Limited is looking for an experienced QMS Manager / Management Representative (MR) to lead and manage our Quality Management System (QMS) as per AS9100 and ISO standards. The ideal candidate will ensure compliance, continuous improvement, and maintain high-quality standards as per Aerospace Industry requirements. Responsibilities: Manage and maintain the Quality Management System (QMS) in compliance with AS9100, ISO 9001, and customer standards . Act as Management Representative (MR) for customer, third-party, and certification audits . Conduct internal audits, identify non-conformities, and drive corrective & preventive actions (CAPA). Handle customer complaints, root cause analysis (RCA), and implement preventive measures. Review and control QMS documentation: SOPs, Work Instructions, control plans, PFMEA, etc. Conduct training programs for employees on QMS and process improvements. Monitor and report QMS performance through KPIs and present findings to top management. Collaborate with cross-functional teams (production, purchase, design, and engineering) for process improvements. Supplier: Quality management and audits. Ensure adherence to EHS (Environment, Health & Safety) standards. Drive continual improvement initiatives to optimize processes and reduce waste. Key Requirements: Bachelors Degree/Diploma in Engineering (Mechanical/Production/Industrial preferred). 8–12 years of relevant experience in QMS/quality systems roles in aerospace/defense/precision component manufacturing . In-depth knowledge of AS9100, ISO 9001, ISO 14001, QMS tools, and compliance standards. Certified Lead Auditor/Internal Auditor for AS9100 & ISO 9001 (preferred). Hands-on experience with CAPA, RCA, FMEA, 8D, PPAP, APQP, SPC, and MSA. Excellent communication, documentation, reporting, and leadership skills. ERP, QMS software, and MS Office proficiency. Knowledge of CNC/VMC operations, GD&T, and NADCAP (preferred).

Position Title: QMS Manager / Management Representative (MR) Company Name: Senwell Exports Private Limited Industry: Aerospace / Precision Component Manufacturing Location: Kesnand, Wagholi, Pune Experience Required: 8 to 12 Years Job Description Senwell Exports Private Limited is looking for an experienced QMS Manager / Management Representative (MR) to lead and manage our Quality Management System (QMS) as per AS9100 and ISO standards. The ideal candidate will ensure compliance, continuous improvement, and maintain high-quality standards as per Aerospace Industry requirements. Responsibilities: Manage and maintain the Quality Management System (QMS) in compliance with AS9100, ISO 9001, and customer standards . Act as Management Representative (MR) for customer, third-party, and certification audits . Conduct internal audits, identify non-conformities, and drive corrective & preventive actions (CAPA). Handle customer complaints, root cause analysis (RCA), and implement preventive measures. Review and control QMS documentation: SOPs, Work Instructions, control plans, PFMEA, etc. Conduct training programs for employees on QMS and process improvements. Monitor and report QMS performance through KPIs and present findings to top management. Collaborate with cross-functional teams (production, purchase, design, and engineering) for process improvements. Supplier: Quality management and audits. Ensure adherence to EHS (Environment, Health & Safety) standards. Drive continual improvement initiatives to optimize processes and reduce waste. Key Requirements: Bachelors Degree/Diploma in Engineering (Mechanical/Production/Industrial preferred). 8–12 years of relevant experience in QMS/quality systems roles in aerospace/defense/precision component manufacturing . In-depth knowledge of AS9100, ISO 9001, ISO 14001, QMS tools, and compliance standards. Certified Lead Auditor/Internal Auditor for AS9100 & ISO 9001 (preferred). Hands-on experience with CAPA, RCA, FMEA, 8D, PPAP, APQP, SPC, and MSA. Excellent communication, documentation, reporting, and leadership skills. ERP, QMS software, and MS Office proficiency. Knowledge of CNC/VMC operations, GD&T, and NADCAP (preferred).

Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive 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.

Role & responsibilities Key deliverables Supervise compliance of cGMP and any other applicable regulatory requirement, including EH&S requirements. Complete self-training and monitor training of team members on the relevant SOPs. Report any quality concern or suggestion for improvement to managers. Execute and supervise all tasks and activities as per the applicable SOPs. To lead and guide site investigation teams to investigate the reported OOS, repeat OOT, deviations and market complaints by working closely with site CFT and operating personnel, to arrive at appropriate RCA and CAPA. To personally lead major/critical/repeat investigations and ensure proper closures. To review and share weekly / monthly report of investigation with focus on key findings, repeats, open issues, CAPA effectiveness, learnings etc. , to the management. To analyze historical data of investigations periodically, to derive trends emerging on any findings or any quality concerns or improvements and notify the management. To review and improve quality of investigations of other investigation members in terms of technical report writing skills as per format. To conduct training programs on technical/ GMP related topics and ensure trainings of subordinates / team members. To participate and support in Investigation management formats, matrices design and implementation. To provide support to site during regulatory inspection or audits / Inspections conducted by local regulatory bodies / vendors / third parties, for related investigation. To support the Quality Management Systems document closure - Deviations, OOS, OOT, LIR and market complaints, change control and CAPA, ensure upkeep of documents related to investigations and ensure compliance in QAMS as per requirement. To perform any additional activity related to investigation as and when required. Key customers Preferred candidate profile Education: B. Pharm / M/Pharm Competencies Education Work Experience 10 to 15 Years Perks and benefits As per standard norms

To ensure plaining and scheduling for annual preventive maintenance of all utilities installed in the plant to attend and timely response for all emergency breakdowns of utility equipment in the plant To ensure and implement GMP requirements in function. Aligning SOP corporate SOP and guideline and to ensure spare part inventory of the utility equipment items in Engineering Stores To evaluate new utility equipment and ETP equipment proposals for Capex modification and its procurement with timely execution support site project team for evaluation and timely completion for utility project To ensure renewal of registrations and licenses related to Utility equipment for concerned Government Department as per Teva standards to ensure the safety of persons, plant Equipment while carrying out the maintenance job. Work procedure update and training To critically analyze the expenditure on procurement of items and utility maintenance expenditure periodically and find out ways and means to control the same at optimum level to review the planning and implementation of energy conversion schemes To ensure timely closely of permanent change Control, temporary change control, deviation, CAPA and service calls of utility function accountable for the performance and results of a team with own disciplined Function Defines Team operating standard and ensures essential procedure are followed based on knowledge of own disciplined, to ensure completion of assigned the training of self Team members Excretive limited management authority, sets employee performance objectives, conducts performance reviews and recommends pay actions To ensure all the activities perform in own discipline for self and team should follow the compliance requirements To support GFM for own discipline in colony and its execution

Overhauling & replacing faulty parts of process & utility equipment. Trouble shooting in case of any abnormality/breakdown & diagnosing the troubles. Responsible for undertaking maintenance, repairs, minor improvement works across the site Recording all maintenance records & reports for future reference Execute preventative and corrective maintenance of equipment s. Ensure work compliance as per job orders/work permits. Responsible for getting the material from Engineering Store for the respective work to be carried out. Ensure preventive maintenance has been carried out within schedule date. Ensure compliance of job order and closure of work permits. Responsible to check the breakdown/maintenance work pending from previous shift and report it. To maintain all document pertaining to maintenance. Responsible for Preventative maintenance of equipment &Documentation as per SOP of the site. Responsible for Safety CAPA execution at site. Handling all documentation as per GMP. Person should have computer skill to handle Maintenance related work. Knowledge of all safety norm as per industries. Knowledge of all safety work permit system as per industries standard.

This role is for one of the Weekday's clients Salary range: Rs 400000 - Rs 600000 (ie INR 4-6 LPA) Min Experience: 3 years Location: Rajkot JobType: full-time Seeking an experienced quality professional responsible for conducting 100% inspection and ensuring the quality of raw and machined castings. The role involves verifying compliance with customer specifications, engineering drawings, internal SOPs, and relevant industry standards. The Senior Quality Engineer plays a key role in identifying non-conformities, supporting root cause analysis, and driving corrective and preventive actions to maintain product quality and integrity. Requirements Key Responsibilities: Perform 100% visual inspection of raw castings to identify surface defects such as cracks, porosity, shrinkage, and other abnormalities using appropriate techniques (e.g., dye penetrant testing). Conduct precise dimensional inspections of raw and machined castings using measurement tools including Vernier calipers, micrometers, height gauges, bore gauges, and CMM. Interpret engineering drawings and GD&T standards (ASME Y14.5, ISO 8062) for inspection and conformance evaluation. Carry out in-process and final inspection of machined components to ensure specifications are met. Review and verify supplier inspection reports and test certificates (chemical, mechanical, NDT). Document and manage non-conformances in line with PPAP requirements and support CAPA initiatives. Maintain detailed inspection records, generate quality reports, and assist in audit preparations (internal, customer, third-party). Ensure compliance with relevant quality management systems such as ISO 9001, IATF 16949, or AS9100. Collaborate with production, engineering, and supply chain teams to resolve quality-related issues. Operate and calibrate inspection tools and ensure traceable records are maintained. Qualifications & Experience: Diploma or Bachelor's degree in Mechanical or Production Engineering (or equivalent). Minimum 5 years of hands-on experience in casting and machining inspection within a manufacturing environment. Preferred: NDT Level II certification (PT, UT) and knowledge of CMM programming. Skills & Competencies: In-depth understanding of casting methods (e.g., sand casting, investment casting) and machining operations (e.g., turning, milling, boring). Strong proficiency with a wide range of measurement instruments, including CMM. Familiarity with surface finish standards (e.g., Ra values) and comparator tools. Knowledge of quality tools such as sampling plans (AQL, ANSI Z1.4), SPC, and root cause analysis techniques (5 Why, Fishbone). Excellent attention to detail, documentation, and reporting skills. Proficiency in Microsoft Excel and basic computer applications. Work Environment: Based in a shop floor and inspection lab setting. Exposure to operational conditions such as heat, noise, or oil may be required. Mandatory use of personal protective equipment (PPE) in accordance with safety standards.

Overall responsible for New Project, Modification jobs activity in the plant as per requirement of site. Project management and execution of new and expansion project from Design to till handing over to plant. Also closing of project with capitalization. Responsible for execution of project with given time line. Compliance of all statutory & GMP requirement in new project. Design & compliance of safety practices at site and to ensure zero reportable incidents. Coordination with consultant for technical aspect. Evaluation of Design, drawing, technical specification as per Teva Standards. Procurement assistance to SCM for project. Installation and commissioning of project as per standard/ Teva guidelines. Indenting of material and technical evaluation of vendors. Coordination with all vendor/ consultant for deliverables. Responsible for project result, forecasting and controlling-project schedule & cost. Preparations of budget estimate for proposed/ new project. Manpower & Contract Management Responsible for attending/rectification of mechanical breakdowns in the plant through job orders/permits. Responsible for preventive maintenance of equipment s as per schedule& closer in ERP system. Co-ordinate with other service team for problem rectification in plant. Responsible to overall maintenance of production block. Responsible to carry out the preventive maintenance/overhauling of cGMP Equipment, critical equipment and its subparts etc. as per schedule. Responsible for spare part main Preparation of Equipment Layout, Plant Layout, P & ID (Piping & Instrumentation Diagram), PFD (Process Flow Diagram). Responsible for Permit issuance & safety compliance of assigned plant. Responsible for GMP& EHS CAPA and deviation closure and updation. Your experience and qualifications B.E. / B.Tech(Mechanical) 8+ Years of experience.

To do planning and scheduling for annual preventive maintenance and calibration of all electrical and instrument installations in the Plant To attend and timely response for all emergency breakdowns of electrical and instrument installations in the plant. To ensure tentative schedule for earthing audit of all electrical installations and its execution, also scheduling & implementations of other GMP requirements. To ensure implementing compliances of computer validation as per 21CFR part 11, GAMP-5 and other relevant guidelines. Ensure the GMP compliance in calibration lab and instrument function. To inspect and approve the electrical and instrumentation items received in Engineering Stores. To evaluate new equipment/facility proposals for Capex & modifications and its procurement with timely execution. Support site project team for evaluation and timely completion of project. To ensure renewal of registrations and licenses related to power & electrical safety from concerned Government Department and for weighing items with Weight & Measurement government authority. To ensure the safety of persons, plant and equipments while carrying out the maintenance job. Work procedure update and training. To critically analyze the expenditure on procurement of items and overall electrical and To do planning and scheduling for annual preventive maintenance and calibration of all electrical and instrument installations in the Plant To attend and timely response for all emergency breakdowns of electrical and instrument installations in the plant. To ensure tentative schedule for earthing audit of all electrical installations and its execution, also scheduling & implementations of other GMP requirements. To ensure implementing compliances of computer validation as per 21CFR part 11, GAMP-5 and other relevant guidelines. Ensure the GMP compliance in calibration lab and instrument function. To inspect and approve the electrical and instrumentation items received in Engineering Stores. To evaluate new equipment/facility proposals for Capex & modifications and its procurement with timely execution. Support site project team for evaluation and timely completion of project. To ensure renewal of registrations and licenses related to power & electrical safety from concerned Government Department and for weighing items with Weight & Measurement government authority. To ensure the safety of persons, plant and equipments while carrying out the maintenance job. Work procedure update and training. To critically analyze the expenditure on procurement of items and overall electrical and instrument maintenance expenditure periodically and find out ways and means to control the same at optimum level. To review the planning and implementation of Energy conservation schemes. Represent as Energy Champion for the site. To ensure timely closer of permanent change control, temporary change control, deviation, CAPA and service calls. Is accountable for the performance and results of a team within own discipline or function. Defines team operating standards and ensures essential procedures are followed based on knowledge of own discipline. To ensure completion of assigned training of self and team members. Exercises limited management authority; sets employee performance objectives, conducts performance reviews and recommends pay actions To ensure all the activities perform in own discipline for self and team should follow the compliance requirement.

Job Description JOB DESCRIPTION Position Title: Quality Manager Reports to: Operations Location: Noida Experience: At least 10 years related working experience in a manufacturing environment with at least 5 years in management position. Working experience in automotive industry is a must. Academic: B-Tech / BE Overview: The Quality Manager at IMI Transport plays a crucial role in maintaining and enhancing the highest standards of product quality and regulatory compliance. This position leads the implementation and maintenance of effective quality management systems, driving continuous improvement to enhance customer satisfaction and organizational efficiency. Key Responsibilities: ? Maintain and enhance the Quality Management System, implementing IATF 16949 and VDA management system requirements. ? Serve as the Management Representative to ensure compliance with quality standards. ? Oversee quality checks according to relevant ISO standards and maintain systematic documentation of records. ? Lead and participate in process improvement projects to enhance quality and efficiency. ? Direct Corrective & Preventive Action (CAPA) processes using methodologies such as 8D, A3, and 3C. ? Drive a culture of continuous improvement to maximize customer satisfaction and company profitability. Skill Sets : 1. Quality Management Systems Expertise: ? Extensive knowledge of IATF 16949, ISO 9001, and VDA standards. ? Proven track record in implementing and maintaining robust quality management systems in the automotive industry. 2. Analytical and Problem-Solving Skills: ? Proficient in data analysis and interpretation for identifying trends and quality issues. ? Expertise in root cause analysis and corrective action implementation using tools like 8D, A3, and FMEA. 4. Regulatory Compliance Knowledge: ? In-depth understanding of regulatory requirements and compliance standards in the automotive sector. ? Experience in preparing for and leading quality audits (internal and external). 5. Communication Skills: ? Excellent verbal and written communication skills for effectively conveying quality policies and procedures. ? Ability to collaborate with cross-functional teams and present complex information clearly. 6. Customer Focus: ? Strong commitment to enhancing customer satisfaction through effective quality assurance practices. ? Ability to address customer concerns and feedback with appropriate quality responses. 7. Familiarity with Quality Tools and Techniques: ? Proficient in quality improvement methodologies such as Lean and Six Sigma. ? Experience with statistical process control (SPC) and quality metrics. 8. Continuous Improvement Mindset: ? Passion for driving a culture of continuous improvement within the organization. ? Openness to innovative ideas and approaches that enhance quality and efficiency. Key Performance Indicators (SMART Goals): ? Specific: Implement and document quality management systems in accordance with IATF 16949 and VDA standards within the first 6 months. ? Measurable: Achieve a minimum of 95% compliance in internal quality audits annually. ? Achievable: Lead at least 3 process improvement projects per year, resulting in a 10% reduction in defect rates. ? Relevant: Maintain customer satisfaction ratings above 90% through effective quality assurance processes. ? Time-bound: Ensure all quality documentation is up to date and compliant with ISO standards by the end of each quarter.

Role & responsibilities: Experience on Mechanical design. Experience of delivering on Design change management , Design documentation , Risk management, DFEMA. Medical Device industry experience will be preferred . Skill Set: Must have - Medical Domain & Process Mechanical Design and Design Documentations Risk Management , Understanding of Product design cycle DFMA , GDnT , Medical domain Quality process Medical Regulatory Keywords & Tools: Medical Device industry experience Design Documentations. Solidwork , PLM Windchill, CAPA

Position: Contract Engineer Project portfolio and Quality Key Purpose of the Job: As a member of the Project Management team, the Contract Engineer will facilitate project gate reviews, act as a project scheduler, and consolidate gate meeting outcomes (GO/NO GO). The role involves monitoring risk assessments, advising project teams on gate outcomes, and ensuring adherence to quality standards at each project stage. The engineer will also support project quality initiatives, certification processes, and problem-solving methodologies such as 8D and ISO standards Key Responsibilities: Facilitate project gate reviews and consolidate outcomes. Act as a project scheduler and ensure alignment with established processes. Monitor and follow up on project status with various stakeholders. Ensure projects meet defined quality criteria at each stage. Support project quality initiatives, including certification and audits. Apply problem-solving methodologies (8D, RCA, CAPA, 7QC tools). Conduct risk assessments and support mitigation planning. Collaborate with cross-functional teams including sales, engineering, manufacturing, and supply chain. Support ISO 9001:2015 internal audits and compliance. Manage KPIs, MIS reporting, and participate in Management Review Meetings (MRM). Qualifications: Bachelors degree in Mechanical, Industrial, Mechatronics or Electronics Engineering. 3-5 years of relevant functional experience in a similar role. Key Skill & Knowledge Profile Strong knowledge of project scheduling and stage gate processes. Experience in an OEM environment with cross-functional collaboration. Understanding of manufacturing processes and terminology. Familiarity with project quality standards and tools (8D, 7QC, RCA, CAPA). Knowledge of ISO 9001:2015 and internal audit procedures. Proficiency in MS Office and project management tools. Strong communication and interpersonal skills. Self-motivated, detail-oriented, and capable of working in a fast-paced environment. Project Management Certification (not mandatory). 9880612200 - Sudina