1381 Qms Jobs - Page 46

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. Designation: Associate Manager QA Job Location : Mangalore Department: MSEZ- Quality Assurance About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. Job Purpose: Associate Manager – Quality Assurance to manage QMS activities Educational Qualification: M.Sc. (Chemistry), B Pharma/M Pharma or any other equivalent university degree. Experience: 8 to 12 Years Technical Skill: Participation in regulatory inspections and audits and managing responses and corrective actions. Ensuring compliance with data integrity policy and identifying the cause of non-compliance. Responsible for all engineering quality assurance activities and not limited to: Review and approval of Calibration / PM planners and schedule/ Engineering and Maintenance documents/ SOPs of Engineering and Maintenance. Review and approval of Information Technology related documents Handling of LMS Training Activities. Compilation and Preparation of Quarterly QMS trends Preliminary review of Quality notifications (such as Change control, Deviation, CAPA, Customer complaints, OOS, OOT) for its completeness and correctness. Preparation and review of Quality Agreement. Client communication. Vendor Qualification. Preparation and/or review and/or approval of Standard Operating procedures and ensuring the adherence to the guiding SOP. Review and approve of equipment qualification and engineering related validation documents for its adequacy and accuracy. Reviewing the risk assessments for its adequacy and accuracy. Familiar with Trackwise, EDMS, SAP and LMS applications. Key Responsibilities: Establishing and maintaining a robust QMS in accordance with regulatory requirements (e.g., ICH, FDA, EMA). Management of Site QMS and trending. Management of document archival. Site Training coordinator. Technical/functional Skills: • Good communication skills and experience in API industry. Behavioural Skills: • Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team. • Good speaking-listening-writing skills, attention to details, proactive self-starter. • Ability to work successfully in a dynamic, ambiguous environment. • Ability to meet tight deadlines and prioritize workloads. • Ability to develop new ideas and creative solutions. • Should be able to work in team and flexible for working in shifts. • Should be a focused employee. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Key Responsibilities: Establishing and maintaining a robust QMS in accordance with regulatory requirements (e.g., ICH, FDA, EMA). Management of Site QMS and trending. Management of document archival. Site Training coordinator. Technical/functional Skills: • Good communication skills and experience in API industry. Behavioural Skills: • Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team. • Good speaking-listening-writing skills, attention to details, proactive self-starter. • Ability to work successfully in a dynamic, ambiguous environment. • Ability to meet tight deadlines and prioritize workloads. • Ability to develop new ideas and creative solutions. • Should be able to work in team and flexible for working in shifts. • Should be a focused employee.

Hiring for "Executive " for Leading Biotechnology company Knowledge of Protein Purification Knowledge of GMP standards, SOPs and quality management systems Awareness of QMS as per ISO13485: 2016 and ISO 9001:2015 standards.

Role Description: This role will form a core part of our Global Excellence Centre (GEC) Arcadis centralized and fully integrated project delivery group. Our GEC is made up of more than 3,000 talented individuals working in offices across India, Romania and Philippines, providing Capability, Capacity and a Competitive Advantage across a wide array of unique projects and services, in collaboration with our global businesses. Advanced Process Manufacturing within the GECs is comprised of cross-functional teams, that contribute to the design & development of innovative process engineering solutions in Pharmaceutical, Semi-Conductor & Process industries. Our ability to effectively manage projects, assess client needs, and provide technical guidance is crucial in delivering successful outcomes, using the most innovative way of doing computational design. Your role will include, but is not limited to: Preparation of plant equipment layouts, process flow diagrams, equipment sizing & P & IDs. Preparation of Specifications, for Process Equipment, Utility Equipment Warehouse Equipment etc. Mass & Energy balances to calculate Utility Load requirement. Knowledge of instrumentation Control requirement & Preparation of plant process control Philosophies. Provide required process input to Instrumentation team for instrument process data sheets. Input to project schedules and monitoring tasks to meet milestones during each phase. Develop documentation, diagrams, and specifications to meet project requirements and regulatory standards. Prepare scope of work documentation for use in project planning. Participate in project reviews to enable ongoing status tracking and reporting. Prepare & review project documents i.e. DQ, IQ, OQ & PQ Qualifications, FAT/SAT protocol & reports etc. Ensure adherence to industry standards and best practices in Process designing. Adhering to cGMP guidelines and work as per Arcadis SOP/Work instructions. Compliance to SHE & Sustainability Performs the tasks within the agreed-upon budget and schedule. Qualifications Mandatory: Bachelors degree in engineering (chemical, mechanical, industrial or similar). 8 years of experience as a process engineer in a design consultancy or GMP manufacturing environment. Knowledge of process analysis & process modelling. Working knowledge of process safety, risk assessment and compliance with regulatory standards. Good project management skills with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Ability to manage multiple projects simultaneously and meet deadlines in a fast-paced environment. Nice to have: Masters degree in process engineering or a related field. Professional certification in process engineering or related areas. Experience with process automation and control systems. Knowledge of process simulation software and computer-aided design (CAD) tools. Solid understanding of quality management systems, such as ISO standards. Experience of sterile processing Knowledge of Hazardous Area Classification Experience of high potency pharmaceuticals Experience of both small molecule and large molecule process design

Role & responsibilities Implement and maintain quality control standards for precast concrete production processes Develop and enforce quality assurance protocols to ensure compliance with industry standards and regulations Lead and manage a team of quality control inspectors and technicians Conduct regular inspections and tests on raw materials and finished precast products Identify areas for improvement and implement corrective actions to enhance product quality Collaborate with engineering and production teams to resolve quality-related issues Prepare and maintain accurate documentation related to quality control processes and procedures Stay updated on advancements in precast technology and incorporate best practices into the quality management process Ensure adherence to safety guidelines and promote a culture of safety within the quality control team Participate in internal and external audits to demonstrate compliance with quality standards Education Qualification Bachelor of Engineering in Civil Engineering or related field Certification required Quality Management Certification (e.g., Six Sigma, Lean Management) Technical Skills Thorough understanding of precast concrete manufacturing processes Knowledge of quality control methods and tools specific to the precast industry Experience with quality management systems and software Familiarity with relevant industry standards and regulations (e.g., PCI, ASTM) Ability to interpret technical drawings and specifications

Urgent Required Quality Engineer in manufacturing company for Chimbali, Pune location. Required Qualification: Diploma / BE / ITI -Mechanical Required Experience - 2 Yrs. - 4 years Role & responsibilities 1. Handling Incoming quality inspections team. 2. In-process quality inspection 3. PDIR for each supply 4. Excellent communication skills and interpersonal skills. 5. Should be able to coordinate with end customer independently for any customer complaint / requirement. 6. Good in MIS preparation. 7. Knowledge of QMS, ISO, IATF and other quality standards. 8. Developing and implementing quality standards and quality control systems 9. Monitoring and analysing quality performance. 10. Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met. 11. Collaborating with operations team to develop and implement controls and improvements. 12. Ensuring that workflows, processes, and products comply with safety regulations. 13. Investigating and troubleshooting product or production issues. 14. Developing corrective actions, solutions, and improvements. 15. Reviewing codes, specifications, and processes. 16. Strong analytical and problem-solving skills..

Key Responsibilities Be a part of sustaining project team and work in the design quality engineering across the entire product cycle. Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable) Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts (if required) for commercial products. Manage electronic document control and version control on all project related documents. Ensure adherence to the quality systems and design assurance SOPs and customer’s PLCP. Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution. Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Acts as an effective communicator or team member in supporting quality disciplines, decisions, and practices. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Quality System Requirements In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. For those individuals that supervise others, the following statements are applicable: Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Customer’s Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System. Job Scope and Leveling Guidelines Functional Knowledge Requires expanded conceptual and technical and/or functional knowledge in Medical Device Design Quality domain. Broadens capabilities in applying concepts in job function. Business Expertise Demonstrates working knowledge of business and industry practices and company processes to accomplish own work. Leadership No supervisory responsibility; accountable for own contributions and meeting objectives. Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules. Problem Solving Uses and exercises judgment to solve problems in straightforward situations and determine appropriate action/solutions. Works under general direction from more senior level roles/manager Candidate should have 5+ years of experience

Establish, document & implement QMS, ensuring aligns with relevant ISO standards & industry best practices. Manage the QMS documentation. Prepare for & manage external audits by certification bodies, ensuring compliance with standards. Audit Planning Required Candidate profile Provide training to employees on quality systems, ISO standards & their roles & responsibilities. Develop & implement quality metrics & KPIs. Serve as a liaison between the company & external parties.

1.Responsible for batch record issuance. 2 Responsible for issuance of change control 3.Resposible for implementation of ISO & Quality Management System 4. Responsible for calibration & validation of Equipements & Instruments 5. Responsible for inprocess Quality Checks 6.Resposible to implement CGMP 7. Responsible to monitor product activity 8. Responsible for issuance & retrival of control document 9. Resposible for dispatch verification 10. resposible to prepare process validation proyocal & record

JD- • Ensuring quality and regulatory compliance as per ISO 9001:2015 standards •Coordination with design, manufacturing and other functions to reduce defects in the systems •Identification of new vendors and evaluate their technical, commercial .

Job : System Verification Engineer Location: Bengaluru Experience: 8 + Years Qualifications Create clear product design documentation such as concept diagrams, specifications, requirements, test plans, and V&V reports perform test/verification for NPI or sustaining of innovative electromechanical products Establish and maintain traceability between requirements, and testing Develop test protocols for the purposes of design verification and validation Execute testing and generate associated reports Oversee the building and testing of prototypes, including internal team and external vendor management Performs hands-on system testing and troubleshooting of technical issues Design benchtop tests, fixtures, and regression test plans to prove out concepts, functionality, and safety Required Qualification Bachelors degree in electrical, Computer, Biotechnology, Systems Engineering, or other related field. 8+ years experience in electromechanical device and system design/verification for new product development Direct hands-on systems engineering experience, preferably with medical device electronic systems or other complex electronic hardware. Technical competencies: Experience developing software driven electromechanical devices in a regulated environment. Broad engineering expertise across all engineering disciplines. Direct experience in requirements authoring, decomposition, analysis, traceability, and verification. Direct experience with complex electronics systems/component design. Experience in writing detailed product Verification/qualification plans and reports. Experience with integrated systems verification, including developing hardware verification test plans and verification test reports. Previous experience with change management Hands-on experience building, testing, and troubleshooting prototype devices Ability to manage and prioritize workload, multi-task and manage a diverse mix of issues, responsibilities, and challenge. Preferred Qualifications Familiarity with all phases of the product development lifecycle. Familiarity with HW / Embedded SW development, integration, and verification Familiarity with scripting and data analysis experience using Python, MATLAB, or equivalent programming languages. Experience working with 3D design tool, Creo , Solid works , Fusion 3Detc. Experience with low fidelity prototyping 3d Printing, PCB design, PCB reworks etc. Experience in the medical device industry, ISO 13845 , FDA quality management system Enjoy working effectively as part of a small, fast-paced, cross-functional, cross-cultural integrated team.

Role : Project lead Discipline : Civil QA/QC Qualification : B. Tech Description : having 15 + years experience in handling high rise residential towers handled projects of Aluminum form work – MIVAN technology certification into QMS, IMS or other quality related courses. Exposure towards QA/QC aspects. Location : Hyderabad

Role & responsibilities: Provide strategic leadership in developing, implementing, and managing comprehensive quality assurance programs within the manufacturing environment. Should have knowledge of ISO standards and should have conducted the ISO audits Lead and mentor a team of quality assurance professionals, fostering a collaborative and results-driven work environment. Coordinate and delegate tasks, ensuring efficient and effective team performance. Manage and maintain accurate documentation of quality assurance activities. Generate comprehensive reports on quality metrics, providing insights for continuous improvement. Develop and implement training programs for manufacturing personnel to enhance their understanding of quality standards and processes.

Role & responsibilities Managing the Quality and Information Security Management System and ensuring GMP compliance is incorporated. Agreeing standards and establishing clearly defined quality methods for staff to apply. Liaising with clients auditors and ensuring the execution of corrective action and compliance with clients specifications. Identifying relevant quality and GMP related training needs and delivering training. Guiding the relevant stakeholders on quality and regulatory requirements on innovation projects. Function as an internal auditor for QMS, ISMS, and BCP as required. Managing and developing the Document management system. Ensuring the CAPA system is managed with the objective of continuous improvement. Ensuring compliance with appropriate standards and regulation. Ensuring external audits for critical suppliers are attended to or led by a member of the quality department. Drive on-time closure of all observations, opportunities for improvement and NC’s (if any). Complying with SOPs (Standard Operating Procedures) and Work Instructions as detailed on Training Records and Training Matrixes. Effectively interact with the company departments to ensure the delivery of the product to specification and promote the improvement of the QMS. Updating of Quality Records, as detailed in the appropriate SOPs. Comply with Perigord centralised Global Quality and Information Security Management System. Provide daily / weekly update over email and review calls to the Quality Manager and Global Head of Quality Preferred candidate profile Bachelor’s degree qualification in a life science, technical or engineering discipline. 4+ years of relevant Quality Assurance or relevant experience in Life science and or Software services company Demonstrate excellent communication skills (oral as well as written) Ability to work with minimum supervision. Ability to work within a challenging environment with tight delivery timelines. Additional Desired Preferences: Knowledge of Computer System Development Life Cycle Good technical understanding of IT infrastructure Experience dealing with regulatory agencies and global audit teams.

2 yr BPO Quality Manager on the paper(Insurance outbound sales)..Training Manager will be an advantage Exp , AM/DM cannot apply Call Callibration, Quality Audit, Quality Score , CSAT Required Candidate profile WFO-Kolkata only not for Delhi/NCR and Bangalore .Apply those who can relocate in Kolkata IMMEDIATE JOINER GRADUATE Call/whatsapp CV Amit 8851792136, Neha 8287267407

Testing methods - Mechanical, Physical & Electrical is essential Handling Various measuring Instruments. Customer Complaints- Investigation and analysis, reduction Documentation ofISO, IATF 16949,and otherQMS,5S,Kaizen. Audits

1. To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish product and packing material. 2. Assistance in preparation of SOP of various departments/ preparation of draft SOPs. Required Candidate profile To review manufacturing, store, QC activity. To prepare approved vendor list and maintain vendor qualification. To Attend QR meeting as per schedule Call/ Whatsapp : 91-9327657730 / 9724346949

To head the Quality Deptt in any cutting the edge pneumatic parts manufacturing MNC Oorganize internal / external Audit Process Improvement from Rejection Analysis till to zero Defect Cost Optimization/ Value Engg Inspection and Root Cause Analysis Required Candidate profile Inspection and Testing use quality tools such as 8D & 7 QC Tools, APQP, PPAP, DFMEA & PFMEA, MSA, SPC, Process & System Audit, VDA 6.3, ISO, ASES, IATF share cv; info.dronehr@gmail.com 9990013340 (WA)

collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications. Ensure that all necessary documentation is completed accurately Call: 91-9327657730 / 9724346949 Required Candidate profile Nitrosamine Impurity, Elemental impurity, Genotoxic Impurity & their role related DMF Filing. Preparation & review (MOA), standard testing procedure (STP) and other documents related to QC.

Job Description Summary Product quality review associated with the manufacturing process. Impacts quality of own work and the work of others on the team. Executes standard operational/technical tasks typically subject to instructions and work routines. There is latitude to rearrange the sequence to complete task/duties based on changing work situations. Company Overview: Working at GE Aerospace means you are bringing your unique perspective, innovative spirit, drive, and curiosity to a collaborative and diverse team working to advance aerospace for future generations. If you have ideas, we will listen. Join us and see your ideas take flight! Site Overview: Our Multi-modal Manufacturing Facility (MMF) in Pune plays a crucial role in manufacturing key aerospace components, supporting not only Indias defense and commercial sectors but also global aviation supply chains. Our relationships with Indian suppliers, combined with our world-class local facilities and global reach, continue to shape Indias aerospace ecosystem. Roles Overview: Own quality assurance & Quality Control for Aerospace Machining Quality Management System and TRS (AS9100, customer certifications) and Regulatory approvals including NADCAP Responsible for Quality Metrics including Customer escape, COQ, FPY, DPU, Defects Customer Issue Resolution, On-Time Qualification etc. Manage FAI according to AS9102, ensuring CMM inspection planning & OEE Owns Quality Planning activities such as APQP, Control plans, Inspections etc. Measuring instrument / Gauges development, management, and control Manage Weekly/ Monthly Operating Rigor with customers and own wing to wing quality metrics Work with cross functional team, executive APQP at MMF. Plan and develop inspection activities & control people Knowledge of QMS for Machining COE with AS9100 compliance Drive Customer satisfaction with VOC & improvement actions. Use risk-based approach to develop audit program, plan, and execute audit/assessment through complete PDCA cycle. Manage the QMS audit/assessment nonconformity database, provide detailed analysis of nonconformities. Lead cross-functional QMS-process improvement initiatives to drive process lean using systematic approach. Driving MRB reviews. The Ideal Candidate: Candidate shall have good understanding GD&T and its application in Machining, performed FAIs as per AS9102, AS9100 Certified internal auditor having Strong understanding of QMS of aerospace. Advantages to the candidate having DSQR & PQE qualification. Understand APQP requirements and Quality KPIs such as COQ, DPU etc. Should able to Manage the team and cross functional interaction. Qualifications/Requirements: Bachelors degree in engineering (Aerospace / Mechanical/ Production) Have Min 2 to 6 years relevant experience in Machining Quality with Aerospace background Experience of managing team. Desired Characteristics: The candidate shall be highly energetic and passionate with positive attitude. He shall be able to explain clearly business drivers and organizational objectives to team The candidate be a strong decision maker with willingness to stretch limits of self as well as team as per business needs Experience in Six Sigma, Lean manufacturing and value stream mapping will be added advantage Must have hands on experience of QMS (Such as AS9100, ISO9001, Nadcap etc.) process definition, implementation, monitoring and leading audit/assessment, in mid-size organization. Must be an internal auditor per AS9100 Must have working knowledge of analytical/statistical methods, product/process quality planning, APQP per AS9145, AS13100 etc., advanced knowledge of Microsoft apps. Must have knowledge of S-1000 and S-400. Certified PQE and DSQR is Preferred. Knowledge of Calibration of instrument & equipment's, NABL 17025 certification Must have experience on product qualification process per customer requirements NDT NAS 410 FPI level II Preferred. Excellent Hand on experience in GD&T application in inspection. Relocation Assistance Provided: Yes

CANDIDATES HAVING EXPERIENCE IN EXTERNAL / TOPICAL PREPRATIONS (Ointment, Creams, Gels) WILL BE GIVEN PREFERENCE. Key Responsibilities: Review and verify quality-related documents and procedures. Handle change control, deviations, and impact assessments. Manage incidents, investigations, and CAPA implementation. Oversee market complaints, product recalls, and mock recalls. Prepare and review SOPs, validation protocols, and reports. Ensure compliance with batch manufacturing and packing records. Monitor shop floor activities for quality assurance. Implement and manage quality control processes. Perform other tasks as assigned by management. Preferred candidate profile Required Qualification: - B.Pharma/M.Pharma Industry : Pharmaceutical Formulation/API Experience: 06 - 11 Years Role: Sr.Officer/Executive Department: Quality Assurance Employment Type: Full Time, Permanent CTC: Will depend on Current CTC & Interview Performance.

CANDIDATES HAVING EXPERIENCE IN EXTERNAL / TOPICAL PREPRATIONS (Ointment, Creams, Gels) WILL BE GIVEN PREFERENCE. Position Overview: As an Assistant Manager in the Quality Assurance department at Universal Twin Lab in Silvassa, you will play a pivotal role in ensuring compliance, quality, and operational excellence within the pharmaceutical manufacturing environment. Reporting directly to the Quality Assurance Manager, you will assist in leading a team responsible for validation, qualification, quality management systems (QMS), documentation, and overall compliance. Role & responsibilities Lead QA team in ensuring compliance and quality standards. Oversee QMS activities including change control, deviations, complaints, recalls, and CAPA. Assist in process validation for oral solid dosage forms. Coordinate equipment and utility qualification activities. Review and approve master documents and reports. Participate in audits and inspections. Monitor daily QA activities and prepare regular reports. Preferred candidate profile Required Qualification: - B.Pharma/M.Pharma (MALE Only) Industry : Pharmaceutical Formulation/API Experience: 10 - 15 Years Role: Assistant Manager QA Department: Quality Assurance Employment Type: Full Time, Permanent CTC: Will depend on Current CTC & Interview Performance.

Will be responsible for overseeing the entire quality assurance process, including the development and implementation of quality assurance policies, conducting inspections, monitoring production processes, and ensuring compliance with industry regulations. The individual will also be responsible for identifying areas for improvement, implementing corrective actions, and providing training to staff on quality standards. Experience in developing and implementing quality assurance policies and procedures Proficiency in conducting inspections and monitoring production processes Knowledge of industry regulations and compliance standards Strong analytical and problem-solving skills Excellent communication and interpersonal skills Ability to identify areas for improvement and implement corrective actions Experience in providing training on quality standards Quality System Implementation and Auditing. Experience in implementing diverse quality systems such as ISO 9001, ISO 22000, EMS and OHSAS across industries including FMCG, automobile, and alcoholic beverages. Demonstrated success in auditing these systems, ensuring compliance, and driving continual improvement initiatives. Skilled in handling in analysis, documentation, and conducting internal audits, resulting in enhanced process efficiency, product quality, and customer satisfaction. Regulatory Compliance Management: Ensuring compliance with various regulatory standards such as FSSAI, Factory Act, State PCB, FSSC 22000, IMS, NABL, and other industry-specific requirements. Expertise in implementing and maintaining integrated management systems (QMS, EMS, OHSAS). Quality Management Systems: ISO Standards: ISO 9001, ISO 22000, ISO 14001, ISO 45001 | FSSC (Food Safety System Certification): FSSC 22K, EMS (Environmental Management Systems) | OHSAS (Occupational Health and Safety Management Systems) | SA 8000

Sr Manager - Quality Location: Cochin Experience: 15-20 years Qualification: BTech/MTech in any Discipline Key Responsibilities: Lead and manage the Quality Assurance function within the R&D environment, ensuring high standards of quality for electromechanical products. Oversee the implementation and maintenance of Quality Management Systems (QMS) in compliance with ISO 9001, AS 9100, TS 16949, ISO 13485 standards. Act as the management representative for QMS, ensuring alignment with organizational goals and regulatory requirements. Conduct and lead internal and external audits, ensuring continuous improvement across R&D processes. Develop and maintain quality processes, documentation, and audits to ensure product and process quality in R&D. Key Requirements: 15-20 years of experience in Quality Assurance, with a strong background in R&D environments (preferably electromechanical products). Proven experience in QMS standards, including ISO 9001, AS 9100, TS 16949, and ISO 13485. Lead Auditor/Internal Auditor Certification. Experience as a Management Representative for QMS. Strong leadership and communication skills to drive quality initiatives and audits within the R&D team. Preferred Skills: Experience in electromechanical product development and quality assurance in R&D environments.

Job Description Job Title: GCP Lead Employment Type: Full time Location: Bengaluru/India Experience: 5-8 Years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Canada, the United Kingdom, Italy, Poland, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities ¢ Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement.. Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and implementing/ monitoring them for QA function, as applicable. Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals. Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance. Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records. Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans. Facilitating regular CAPA status and metric reports to ensure senior management awareness. Participating in governance/oversight activities including trend assessment or other quality review. Knowledge in the area of Clinical Operations is preferred. Required Skills and competencies: Quality Assurance Nonconformance management (CAPA, Deviations, Issues) GCP Stakeholder management Conflict Resolution Problem Solving

JOB SUMMARY Reputed Auto component manufacturing Industry at Oragadam looking for a Quality Supervisor. The incumbent is responsible for the Quality & Documentation Process. Work experience in any automobile or auto component industry can apply. KEY RESPONSIBILITIES: Maintaining Quality Documentations in a daily basis. Having experience in injection molding is an added advantage. Should have knowledge in QMS procedure. Should have ability to manage at least 25 manpower. Monitoring employee attendance and taking disciplinary action if necessary. Monitoring and submitting the line quality reports and final quality reports in a daily basis. Conducting Layout process audit. Providing guidance and support to employees in their work teams to ensure that they are performing in effective way. Should be good in customer handling. Monitoring employee productivity and able to handle shifts management with 100% attendance. MINIMUM ACADEMIC REQUIREMENT Diploma or B.E in Mechanical Engineering EXPERIENCE & SKILLS: Should have at least 2 experiences in injection molding Experience in documentation, manpower handling.