2371 Qms Jobs - Page 30

To handle all Quality Control operations of the production process in the factory To ensure that all the raw materials coming into the factory, the goods produced in the factory & finished goods leaving the factory are upto the set quality standards of the company, as dictated in the quality manuals of the QMS Should be familiar with working with ISO 9001 standards & systems Should be familiar & proficient in the use of all test instruments Should be an expert in record keeping & should be able to independently investigate complaints and identify root causes for the same Is expected to address quality issues proactively & ensure appropriate corrective action is taken for timely and effective closure of issues Monitoring of supplier quality performance & execute validation activities associated with incoming inspections

Job Responsibilities Manufacturing: 1. Execute and monitor routine manufacturing activities as per the batch manufacturing record (BMR). 2. Ensure production is carried out in compliance with cGMP, GDP, safety, and company procedures. 3. Operate, clean, and maintain equipment as per SOPs. 4. Maintain online documentation: BMRs, logbooks, cleaning records, and deviation reports. 5. Coordinate with QA/QC, maintenance, and stores for smooth production flow. 6. Monitor in-process parameters and escalate any deviations or abnormal observations to supervisors. 7. Ensure effective material reconciliation at the end of each batch. 8. Participate in internal audits and implement corrective and preventive actions (CAPA). 9. Train junior staff and ensure adherence to production schedules and targets.

Should have good exposure over all Quality in plastic component. QMS with a System-Driven Organization preferably in Automobile, Plastic Industries. In-process, Final Quality, customer complaint handling, supplier development and Kaizen promotion Required Candidate profile Experience in Manufacturing of Auto interior Plastic Parts manufactured by injection molding, Blow molding and welded assembly.

Urgent requirements for " LTD" company. Designation : Quality Manager Qualification - BE/Diploma Mechanical. Must knowledge required in Sheet Metal Press Shop industry Location: Chakan, Pune Contact no Miss Maya Ma'am :9767897450

: Job Title QA & Testing Portfolio Manager, VP LocationPune, India Role Description Risk & Control helps Corporate Bank (CB) Operations proactively manage the right risks and build and sustain efficient controls. Embedded in this function are senior Quality Assurance Lead Reviewers responsible to lead and implement a quality assurance (QA) program for high-risk manual processes across Corporate Bank Operations. Activities include performing review of the manual processes versus the QA framework, identifying exceptions and areas of remediation, and reporting of results to senior management. Additionally, the role will be heavily interacting with respective coverage areas and reporting and advising on proper control functions, process enhancements, policy/procedure revisions, and training needs. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Lead and conduct QA reviews of complex high risk manual processes performed by various Corporate Banks Operations units across businesses and locations Utilize quantitative and qualitative methods to measure quality and outcomes resulting from the QA review Provide consolidated management information of QA reviews within their coverage areas to ExCo, Senior Management, and other key stakeholders Prepare and submit summaries of QA reviews and report to the business units and other stakeholders Identify and monitor through resolution any exceptions and self-identified issues (SIIs) from QA reviews Maintain documentation relating to the review and test results, and storing them in a centralized repository Assist in the development of standard templates and Key Operating Procedures (KOPs) for the Technology and Operations units Conduct periodic assessments to evaluate effectiveness and efficiency of implemented process controls Support Operations teams in identifying process improvement opportunities Effectively manage and lead a team of reviewers Review and challenge the remediation and closure of complex audit issues and SIIs Your skills and experience The role requires the VP to have significant experience in leading and conducting QA reviews as follows: Solid understanding of QA principles Experience in running effective QA reviews Ability to remain objective and to independently assess processes in CB operational areas Maintain an effective working relationship with the various CB Ops teams Inquisitive and probing approach to problem solving and general assessment Strong analytical skills, high attention to detail, solid organizational and interpersonal skills Ability to communicate effectively to senior management and other key stakeholders Strong ability to interact with, collaborate, communicate and influence individuals at all levels Effective problem solving and decision making capability Experience operating in a complex, global business Excellent written, oral, and presentation skills Profound knowledge and experience of various Operational and IT environments Ability to work in fast paced environment Open minded, able to share information, transfer knowledge and expertise to team members Keeps pace with technical/operational innovation & maintains understanding of the COO processes Proficient with MS Office programs (Excel, PowerPoint, Project, etc.) How well support you About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Pune Plant-Supplier Quality As a successful family-owned company on a path to global growth, the Brose Group offers challenging responsibilities and exciting career opportunities to performance-driven, skilled specialists with solid professional knowledge and proven career expertise who wish to contribute to our company s success. Your tasks Implementation and Maintenance of a Quality Management System in compliance with the Brose Group standards and regulations within supplier quality function. Ensure adequate quality process and systemic controls at supplier end. Achievement of supplier performance and customer satisfaction by continual improvement of the component quality and process. Compliance to organizational targets. Strengthening of relation between supplier and Brose for achieving organizational goal for sustained and cost-effective quality. Shall be in position to recover the justifiable cost from suppliers. Problem solving with application of relevant problem-solving skill sets. Must be in position to take balance decision keeping organization as priority. Shall be demanding and able to drive supplier as per Brose requirements. Independent handling of supplier quality task, the maintenance and the control of all quality relevant routines according the released and described Quality manual and regulations. Lead of supplier quality issues observed at Brose location, from customer concerns in line with standard practices. Install, perform, evaluate and control a systematic and sustainable problem management process under the use of adequate problem-solving methods and the Q2 / QIM / TOPQ. Lead of all suppliers related quality routines like incoming inspection, Requalification Audits and a proper claim management, layout inspection, process audits etc. Coordination of a transparent Reporting system to functional head, with focus on defined KPIs with defined reporting system. Supplier problem resolution with Q2 notification / supplier discussions / PMP / 8D methodology. Control and report of all detected failure cost by a strong use of all relevant analysis methods according to the released standards. Assure the Quality of new Ramp up projects by consequent Lead of all safe launch activities. Well conversant with problem solving tools like 8D / PMP / SPC / MSA / PPAP/ FMEA. System knowledge of EMS14001, VDA6.3, IATF16949 system requirements to ensure sustained implementation of systems. Your Profile Formal Education & Specialization and Work Experience: BE or DME in Mechanical, Automotive or production engineering with 8-9 years of experience in automotive industries preferred. Knowledge of Quality Management system according IATF16949, EMS14001 - implementation. VDA 6.3 auditor. Hands on experience in GD&T and problem solving + CMM handling experience. In depth understanding of quality tools like SPC, MSA, PFMEA, PPAP and APQP. Six sigma is highly preferred. We offer you a modern working environment with our Brose working world Brose offers a high-tech work environment and a wide range of benefits. Along with competitive performance-based compensation and health insurance, our employees also benefit from attractive social and family-oriented programs throughout our North American locations*. Our benefits packages include comprehensive medical and insurance. Brose also provides educational assistance and a variety of community outreach, family, and sporting events. Flexible working hours and a collaborative work environment give our employees the freedom to balance work and personal life. Brose believes in investing in people. We offer a wide range of development programs with great opportunity for individual growth through training, international or regional assignments and tailored career paths. Our objective is to provide our employees the tools necessary to live a balanced life, experience a rewarding work environment and contribute to our surrounding communities. *Benefits package may vary slightly per location Our benefits Health Management Fit and healty Brose Kids Club Care of Relatives Catering Service Relocation Dual Career Leasing benefits Brose Shop Flexible office concept Variable working hours Modern work and communication equipment Performance-based compensation and success payments Corporate discounts Suggestion Scheme IDEAS Our location Pune (Hinjawadi) Brose India Automotive Systems Pvt Ltd Plot No. 5&7, Raisoni Industrial Park, Phase 2, Hinjawadi 411057 Pune, Maharashtra (State) customer service +91 20 6771 7801 +91 20 6671 7850 Apply online now

Business Unit: Cubic Transportation Systems We have a top-tier portfolio of businesses, including Cubic Transportation Systems (CTS) and Cubic Defense (CD). Explore more on Cubic. com. Job Details: Job Description: Job Summary: Performs complex software engineering assignments following designated standards and procedures. Provides technical guidance and leadership, and mentors more junior members of the team. Conceptualizes, designs, codes, debugs and performs development activities in accordance with designated standards and procedures. Works closely with other engineering disciplines. This position typically works under general supervision and direction. Incumbents of this position will regularly exercise discretionary and substantial decision-making authority. Essential Job Duties and Responsibilities: Coordinates and develops project concepts, objectives, specifications and resource needs. Prepares design specifications, analyses and recommendations. Use current programming language and technologies to provide creative, thorough and practical solutions to a wide range of technical problems Design develop and test applications and programs to support the company s products Design develop and test software programs following established quality standards and in accordance with internal engineering procedures including coding, unit testing and software configuration control Complete high- and low-level detailed software design specifications, storyboards and interface specifications Provide support of products through conception to product delivery including problem solving, defect maintenance and support to customer services Prepare reports, manuals, procedures and status reports Participate and work with team members in code reviews and make necessary improvements in code Coaches and mentors junior team members Keeps abreast of improvements and developments within software engineering Supports bid and proposals and customer variation requests Supports and coaches more junior members of the team General Duties and Responsibilities: Comply with Cubic s Quality Management System Comply with Cubic Occupational Health, Safety and Environment policies and procedures Comply with security in accordance with established policies and procedures of the organisations Comply with Cubic Human Resources Procedures Other duties as requested Minimum Job Requirements: Qualifications Four-year college degree in computer science, computer engineering or other related technical discipline. Skills/Experience/Knowledge: 5 years related experience. Experience with, and understanding of, the software development life-cycle Experience debugging and troubleshooting Experience working within Agile/Scrum methodologies Strong in Java SE and Multi-Threaded programming Must have experience in exposing web services using JAX-WS/REST (one-two years during the last five years of experience) Hands on experience in Spring and Hibernate (one-two years during the last five years of experience) Good in SQL Experience in high and low level design Experience on any Enterprise Service Bus (ESB) Experience on Spring Boot and Spring Data Experience on UI development using JS libraries like Angular, React Prior experience in product development Personal Qualities: Effective written and oral communication skills Excellent problem-solving skills Team player Able to prioritize work, complete multiple tasks and work under deadline and budget guidelines. May be required to travel domestically and internationally to include working odd hours, in-line with customer requirement. Worker Type: Employee

JOB DESCRIPTION Job Title: QMS Project Reviewer Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene ( www. syngeneintl. com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Core Purpose of the Role: This is an exciting opportunity to play a role in drug substance development and manufacturing of Syngene. The role will provide exposure to handling clients across the globe, interaction with cross-functional departments and activities involved from product introduction to discontinuation. It provides an opportunity to learn different aspects of product development to commercial manufacturing. Role Accountabilities: Follow GMP, GDP, and GLP procedures as applicable, while performing the assigned task. Create/ revise/ review of procedures (like SOP, protocols, calibration schedule, and other related documents as applicable. ). Review and approval of Master BMR and PDR and its compliance. Review of TTD related to Late phase and commercial. Responsible for issuance and control of BMRs, PDRs, SOPs, EOPs and ECCs. Verify the product details, batch no. , quantity, label, purchase order, RM issue slip, CoA, weights, packing and dispatch record, packing area (not limited to) and provide clearance to dispatch activity. Assessment of SOP vs guidelines for any gaps and taking appropriate actions. Investigate, review of investigation with respect to OOS/OOT and involve in the identification of root cause and to propose the CAPA for identified root cause. Preparation and review of QMS Trends (Deviation, LIR, OOS, OOT, Change control & Complaints). Handling of returned products and product recall. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience 3 - 6 years into Project related QMS activities (Change control, Deviations, CAPA, OOS, LIRs) Must have handled clients Expertise in review of Master Batch Record, Batch Record and Analytical Documents Knowledge on Good Documentation and laboratory practices Good coordination among CFTs Skills and Capabilities Expertise in handling QMS Activities Good knowledge about project related activities Client handling experience Master Batch Record, Batch Record and Analytical Document Review skills Specification and Method of analysis review Good communication skills Education MSc. Chemistry 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.

Educational Bachelor of Engineering,BTech,Master Of Engineering,MTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional : Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology-CAD-CAD - Others

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)

To maintain and control overall QMS documentation. To monitor the compliance of standard operating procedure of all departments. Responsible to handling of FDA and certification works in absence of

Post - Quality head - Casting/ Die Casting and machining Location Pune Khed Rajguru Nagar, Kanhe Email ID jobpune2025@gmail.com bus and canteen Facility contact us 9356395439 Education: B.E. / B.Tech Mechanical / Metallurgy Experience: Minimum 12-15+ years in casting industry with at least 5-8 years in a leadership QA role Atleast Knowledge and process improvement Knowledge: In-depth understanding of aluminium casting defects, quality tools, and automotive quality systems Key Responsibilities: Develop, implement, and maintain ISO 9001 / IATF 16949 / ISO 14001 systems. Monitor product quality at every stage of the casting process (moulding, melting, pouring, fettling, heat treatment, machining). Conduct root cause analysis and implement corrective & preventive actions (CAPA). Lead internal audits, supplier audits, and customer audits. Coordinate PPAP, APQP, FMEA, SPC , and MSA activities. Handle customer complaints and ensure timely resolution. Define and track quality KPIs (rejection %, rework %, customer returns). Train and develop quality team and shop floor operators on quality standards. Manage inspection equipment calibration and control documentation

Develop and sustain the QM in line with the required industry standards(TS16949,ISO140001,ISO 9001,OHAS 18001) accreditation requirement & business req. accross the org. through exiating and new procedures. Certified Lead Auditor

Job Objective: To lead and manage all quality functions across the plant with a focus on ensuring that products meet customer and industry standards, improve internal quality systems, and drive continuous improvement in all processes related to sheet metal manufacturing. Key Responsibilities: 1. Leadership & Strategy o Develop and implement quality strategies aligned with customer requirement. o Lead a team of QC engineers and inspectors. o Act as the point of contact for all customer quality concerns and audits. 2. Quality Systems o Maintain and continuously improve IATF systems. o Lead internal audits, external audits, and management reviews. 3. Inspection & Testing o Oversee dimensional and visual inspection of incoming, in-process, and final parts. o Ensure calibration of instruments and effective inspection setup (CMM, gauges, etc.). o Establish control plans and quality checkpoints in manufacturing. 4. Customer Quality o Handle customer complaints , 5Why and corrective action plans. o Ensure timely closure of customer and internal non-conformances (NCRs). 5. Documentation & Reporting o Maintain quality documentation per QMS requirements. o Track and report quality KPIs: PPM, rejection %, rework %, audit scores, etc. Qualifications & Skills: Education: B.E in Mechanical / Production Experience: 7-10 years in sheet metal industry, with 45 years in a leadership role. Technical Expertise: GD&T, Root Cause Analysis Software: Familiarity with CMM software, MS Office, 3d soft Soft Skills: Leadership, communication, problem-solving, team building

The Quality Assurance Engineer is responsible for ensuring that products meet the required quality standards and specifications throughout the manufacturing process. This role involves developing and implementing quality control systems, conducting audits, and collaborating with various departments to promote a culture of quality. Key Responsibilities: Quality Control: Develop and implement quality control processes and inspection protocols to ensure compliance with internal and external standards. Audits and Inspections: Conduct regular audits and inspections of manufacturing processes, equipment, and products to identify areas for improvement. Documentation: Maintain accurate records of quality checks, audits, and non-conformance reports. Ensure proper documentation of quality assurance activities. Collaboration: Work closely with production, engineering, and supply chain teams to address quality issues and implement corrective actions. Training: Provide training to staff on quality standards and best practices to foster a quality-oriented culture. Continuous Improvement: Lead continuous improvement initiatives focused on enhancing product quality and process efficiency. Compliance: Ensure compliance with industry standards, regulatory requirements, and company policies. Qualifications: Bachelors degree in Engineering, Manufacturing, or a related field. years of experience in quality assurance or quality control in a manufacturing environment. Strong understanding of quality management systems (e.g., ISO 9001). Proficient in statistical analysis and quality improvement tools (e.g., Six Sigma, Lean). Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills. Preferred Qualifications: Certification in Quality Engineering (CQE) or related credentials. Experience with product testing and validation processes. Ability to work in a manufacturing environment with exposure to machinery and production processes.

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Lead handling of QMS activities. Required Candidate profile Strong knowledge of QMS, cGMP, ICH, WHO guidelines,Audit handling and documentation expertise,Leadership and team coordination,Proficiency in handling TrackWise / MasterControl or similar systems

Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA

Job Objective:To lead and manage all quality functions across the plant with a focus on ensuring that products meet customer and industry standards, improve internal quality systems, and drive continuous improvement in all processes related to sheet metal manufacturing. Key Responsibilities:1. Leadership & Strategyo Develop and implement quality strategies aligned with customer requirement.o Lead a team of QC engineers and inspectors.o Act as the point of contact for all customer quality concerns and audits.2. Quality Systemso Maintain and continuously improve IATF systems.o Lead internal audits, external audits, and management reviews.3. Inspection & Testingo Oversee dimensional and visual inspection of incoming, in-process, and final parts.o Ensure calibration of instruments and effective inspection setup (CMM, gauges, etc.).o Establish control plans and quality checkpoints in manufacturing.4. Customer Qualityo Handle customer complaints , 5Why and corrective action plans.o Ensure timely closure of customer and internal non-conformances (NCRs).5. Documentation & Reportingo Maintain quality documentation per QMS requirements.o Track and report quality KPIs: PPM, rejection %, rework %, audit scores, etc. Qualifications & Skills: Education: B.E in Mechanical / Production Experience: 9-12 years in sheet metal industry, with 4-5 years in a leadership role. Technical Expertise: GD&T, Root Cause Analysis Software: Familiarity with CMM software, MS Office, 3d soft Soft Skills: Leadership, communication, problem-solving, team building Other Requirement : 1. Aggressive Attitude. 2. Willing to stay near the plant location.3. Medically fitness mandatory.4. Work Discipline (Safety, Quality).5. Communication on daily work management.Monthly CTC : 60000/-Food Facility : Not Available.Transport Facility : Not Available.Working Days : 6Working Hours : 8 Hrs (Excluding Breaks)Shift : General ShiftWeekly Off : SundayBenefits :* On Role Job* PF, ESIC benefits.* Will help in building a career in the Quality Department* Will get training on various Quality Tools.

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA Department Development Quality Assurance / Formulation Quality Assurance R&D: Handling of QMS documents and Ensure the SOP compliance Review of Formulation Analytical Development Documents & Formulation Product Development Documents. Method Validation and Transfer Protocols and Reports Product development with QbD approach Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs. Review of FRD activities (LNBs, BDRs, PDRs, MFRs and MPR’) SOP’s and Guidelines Preparation and Review and Approval of SOP’s. Responsible for conducting Internal Audits/External Audits for Cross functional Departments in Formulation Division and External Division. Conducting and Coordinating Employee Trainings. Responsible for Review and Approval of Vendor Qualification Should have experience in IPQA and Analytical QA (OSD/Injectable) Ref to Friends or colleagues. Interview Date on 12-07-2025 Company address Plot# 231, IDA Phase -II,, Pashamylaram, Biophore Road, Patancheru, Hyderabad, Telangana, India

* Implement IATF auditing QMS * CAPA processes Supplier monitoring & audit Incoming inspection & team QMS documentation (IATF) Monthly data reporting Customer complaint & CAPA Incoming Activity Awareness Supplier Audit Manpower handling Office cab/shuttle Food allowance Health insurance Provident fund Annual bonus

(Job ID : 418032) BETPL Position: Manager : Quality Control & Assurance Basic Qualifications: 1. At least 10-12 years experience in the mechanical manufacturing industry relevant to Quality Control and Assurance 2. Bachelors/Master’s in Mechanical Engineering/Production Engineering or equivalent 3. End-to-end experience with ISO 9001; ISO 14001; ISO 45001 4. Extensive execution know-how and documentation maintenance for TPI, Internal and External Audits 5. Should be able/willing to commute to BETPL Factory (Shirwal, Satara) on a day-to-day basis compulsarily Preferred Qualifications: 1. Extensive hands-on experience with sections of BPVC code of ASME and certifying bodies like IBR, CBB 2. Understanding of global codes and standards like ASTM, DIN, BS, ANSI, EN 3. Understanding of Welding codes pertaining to global certifying societies/bodies like ASME, API, AWS and ISO 4. Experience in QC standards, codes, procedures and documentation right from material receipt to dispatch for various grades of Carbon, Low alloy, Stainless, Ni, Non-Ferrous Steel Duties: 1. Implementation of procedures for ISO 9001, ISO 14001 and ISO 45001 2. Compiling and exercising QAP for all BETFLOW, BETFITT and BETLOCK range of products 3. Setting up ITPs for all relevant BETFLOW, BETFITT and BETLOCK range of products along with SOPs 4. Setting up relevant SOPs for FATs/SATs for all BETFLOW, BETLOCK and BETFITT range of products 5. Leading and implementing internal audits; maintaining required documentation and audit reports 6. Maintaining documentation right from receipt to dispatch for all QC Procedures for all BETPL product ranges 7. Setting up Quality Dossier for all BETFLOW, BETLOCK and BETFITT range of products 8. Maintaining list of tools, equipment and breakdown/calibration record for all available tools and equipment

In this role, you will partner with cross functional team members to generate, analyze, communicate, and follow up on actions related to data analysis/ reporting for: -Field Corrective Actions administrative reconciliation -Service and Repair work order completion for capital correction and Software updates -Inventory management: loaner set tracking and return for inspection/ replenishment to the field -Other quality systems compliance duties (including data analytics) Responsibilities may include the following and other duties may be assigned Generates and analyzes reports (Field Corrective Actions, Product Hold Orders, Field Inventory) for compliance with KPIs, identification of patterns of performance to KPIs Communicates coming due and/or overdue notifications for field based inventory or post market surveillance needs to affected personnel, their management, and Quality leadership Coordinates with internal stakeholders to implement corrections to product master data. Required Knowledge and Experience Bachelor degree; Engineering or Science degrees preferred Quality assurance/ systems experience in medical or pharmaceutical industry Familiarity with medical device Quality Management System requirements (e. g. , US 21 CFR Part 820, ISO 13485:2016, Regulation (EU) 2017/745) Experience generating and running data queries/ reports across applications Strong verbal and written communication skills and ability to work in a team oriented environment Product Lifecycle Management knowledge/ experience Ability to work independently once trained. Ability to multitask.

1 Responsible for lifecycle management of DSRM procedural documents in EDMS and non-procedural documents within due date which includes document creation, document revision, making document obsolete, making document effective, releasing document, sharepoint update and communication to relevant stakeholders 2 Responsible as SOP coordinator to perform roles as Author in edit step and QA authorisation in Release approval step 3 Responsible to perform role of Training Coordinator in Training step within EDMS as required 4 Oversight and management of compliance of DSRM training requirements and activities in LMS 4 Support and oversight of subsidiary Global PV training status as applicable 5 Oversight and management of Annual Basic PV compliance for India 6 Oversight on teams task completion, annexures, sharepoint updates and people management. 7 Creation of status presentations and other adhoc presentations as required People Management Competencies Strategic Agility Innovation & Creativity Process Excellence Customer Centricity Collaboration Stakeholder Management Developing Talent Result Orientation Education- Life Science Post Graduate, MPharm, BPharm, Work Experience Experience in Pharmacovigilance operations, Quality Management System, Training, Use of Systems for SOPs and Training Management

experienced Quality Head to lead and oversee the quality assurance and control processes at our manufacturing facility in Papparambakkam. andidate will have a strong background in quality management, with in-depth knowledge of ISO and IATF standards.

responsible for MR function for ISO certification (QMS,EMS & OHSAS) responsible for ISO documentation responsible for 5 S implementation Will do safety audit of factory provide safety training and conduct mock drill Required Candidate profile Min 5 years in above profile. In-depth knowledge of ISO 9001, 14001, and 45001 standards ISO Lead Auditor (preferred)(Graduation/MSW/RLI/CLI + Auditor/Lead auditor certification is a added advantage) Perks and benefits Food & Accommodation