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3 - 5 years
5 - 11 Lacs
Chennai
Work from Office
Responsibilities for IMS Coordinator Coordinate with the various departments of company in regard to IMS certification Prepare Standard Operating Procedures and other system requirements in consultation with the various departments, recommend improvement to existing procedures and standardizes forms used in preparation to and as a requirement for System certification Conduct/assist IMS audit and evaluate different areas and processes of the company to monitor compliance to applicable Standards, existing policies, and procedures of the company Check the effectiveness of the Integrated Management System and the implementation of existing policies and procedures necessary for the attainment of company objectives. Assist in drawing up strategies and action plans to attain objectives and effectively implement the formulated corrective and preventive actions. Recommend measures on improving the Integrated Management System and maintain the Companys Integrated Management System Certification. Promote awareness to all individuals of the organization on the IMS Standards and other existing policies and procedures of the company thru trainings and presentations. Prepare training and presentation materials Update and maintain the HSQE NCs and CAPA in the Intranet Maintain and control records and documents of the HSEQ Department Responsibilities for Safety Coordinator Create and implement safety plans while ensuring that they are being followed daily Conduct safety observation reports on a regular basis, depending on the length of the project Attend safety walks and inspections before or during each project to analyze safety risks Skills : - IMS (ISO 9001, ISO 14001, ISO 45001) Certification. IMS Coordinator, IMS preparation and implementation.
Posted 3 months ago
4 - 9 years
2 - 7 Lacs
Sanand
Work from Office
JOB SUMMARY - Team Leader in Formation zone ensures seamless and efficient operation of Electrolyte Injection, Soaking, HT Aging, Laser Welding, Film wrapping and EOL testing, Verify documented abnormalities from prior shift. Confirm a good startup with each operator. Confirm basic standards are in place Support Supervisor to analyse and assist in closure of abnormalities Ensure issues escalation to seek the real time support. Liaisoning with Supply chain, Quality, Maintenance & PE for smooth Production Ensure downtime data is entered in MES report. Review Zone PPM/OEE performance RESPONSIBILITIES - Manage Team of 10 people in the Formation zone in one of the lines to achieve SQD KPIs. Coordinate with Maintenance for Machine availability for Planned Maintenance without affecting zone PPM/OEE. Ensure compliance to 5S, Process, Equipment Safety Standards. Organize and control all production operations within the shift. Handle production/Quality abnormalities, Exceptions, drive problem solving by using organisations standard Problem-solving tools Knowledge, Skills and Experience Essential- A min of 3 years of experience in leading the Production Team in Lithium-ion cell manufacturing plant or Battery Pack manufacturing plant or Solar Cell Manufacturing Plant. In-depth knowledge & Experience in Electrolyte Injection, Laser welding, Film wrapping and EOL Testing . In-depth knowledge in managing exceptions, handling HT, CAPA. Proficiency in Problem solving. Role Specific Qualifications/Certifications Diploma in (Electrical /Electronics),
Posted 3 months ago
4 - 9 years
2 - 7 Lacs
Sanand
Work from Office
JOB SUMMARY Team Leader in Assembly zone ensures seamless and efficient operation of Cutting and Stacking, Mixing, Ultrasonic and Laser welding processes and Equipments. Verify documented abnormalities from prior shift. Confirm a good startup with each operator. Confirm basic standards are in place Support Supervisor to analyse and assist in closure of abnormalities Ensure issues escalation to seek the real time support. Liaisoning with Supply chain, Quality, Maintenance & PE for smooth Production Ensure downtime data is entered in MES report. Review Zone PPM/OEE performance RESPONSIBILITIES Manage Team of 10 people in the Assembly zone in one of the lines to achieve SQD KPIs. Coordinate with Maintenance for Machine availability for Planned Maintenance without affecting zone PPM/OEE. Ensure compliance to 5S, Process, Equipment Safety Standards. Organize and control all production operations within the shift. Handle production/Quality abnormalities, Exceptions, drive problem solving by using organisations standard Problem-solving tools Knowledge, Skills and Experience Essential- A min of 3 years of experience in leading the Production Team in Lithium-ion cell manufacturing plant or Battery Pack manufacturing plant or Solar Cell Manufacturing Plant. In-depth knowledge & Experience in Cutting and Stacking Operations, Ultrasonic and Laser welding operations. In-depth knowledge in managing exceptions, handling NG products, CAPA. Proficiency in Problem solving. Role Specific Qualifications/Certifications Diploma in (Mechanical/Electrical /Electronics),
Posted 3 months ago
10 - 20 years
12 - 22 Lacs
Aurangabad
Work from Office
About The Role : Ensure the adherence of Supplier Quality and In-coming Quality Maintain Incoming parts quality, supplier monitoring and supplier audit Be Part of CFT to have concrete AOI development with CD team during development. Evaluate supplier product quality on regular basis and guide them to achieve consistency in quality. Participate in supplier CAT Meeting. Preparing and implementing supplier wise annual audit plan to improvement and evaluate the suppliers Analyzing the audit report and action plan from supplier for closing NCs Issue Supplier notification for quality issue, debit etc. Adherence of quality systems at In-process Quality Conduct the Internal audit of product & Manufacturing Processes and taking necessary corrective & preventive actions to prevent occurrences. Review Layout testing and Functional testing for production process. Enforce First off, last off, In-process product audit, control charts are implemented. To ensure the Identification and traceability of parts during process and supplies to customer. Maintain the QMS at Plant Provide the details of Customer QMS requirements to Employees Planning internal audit, coordinate to conduct management review meeting (MRM) & prepare minutes of meeting for necessary actions. Carryout IATF internal audit as per plan in coordination with BU QMS lead. Maintain QMS documents legibility & availability. Implement Inspection standard and work instructions related to all QA process Timely submission of revalidated reports and maintain layout inspection records etc. Preparing the plan for process, product and poka-yoke Audit and analyzing audit report. Preparing observation NCs report & tracking and verifying the actions against the NCs to ensure timely closure. Achieve Zero defect out-flow to Customer Control of master sample & revalidation. Promote awareness of customer requirements throughout the organization. Participate in APQP process. Establish Quality control measures at the identified critical control parameters. Ensure enough lighting is there in applicable parts checking area. Control on outsourced processes. Provide and check use of required PPEs to Shift Inspectors. Set the competitive targets for Inspectors to improve Quality and productivity Up-keeping available facility at Quality Lab Monitor the calibration of measuring instruments as per plan Controlling of measuring and testing equipment To follow on testing with outside lab & maintaining the QA lab. NPD Quality Review control plans (Pre-launch and full production) and identify product design and process concerns during product planning stage. Cross verify the documents (Setup approval/first piece approval/in process inspection/ final inspection/ dock audit) Develop action plan to reduce vital RPNs through ME team (Above set baseline) Be active member in CFT for development of Process documents during the Product Planning process (Gate 0) and all steps of DFMEA Participate as CFT member to Calculate the SOD (Severity x Occurrence x Detection) number or risk priority number (RPN) as part of PFMEA Communicate the importance of the implementation of QMS procedures to NPD (Program Management) and ensure alignment to VQS Ensure the entire new product development process has quality assurance built in every step Maintain the Customer Quality, Customer Complaint handling & IHR Attending customer complaint & analyzing defect/abnormality as per customer feedback & keeping documentation of corrective measures. Taking contentment action at customer end, warehouse & BSR. Doing root cause analysis & preparing action plan for taking corrective measures & horizontal deployments. Updating the corrective measures in FMEA Reporting to customer on process side & inspection side corrective action Improve PPM at customer ends. Participate in CAT meeting and reporting the action taken in timely manner to management and customers. Attending planed /surprise customer audit. Maintaining shop floor activities as per Customer Audit Check sheet in order to maintain customer audit score, product and process quality as per customers standard requirement (CSR). Preparing and implementing actions as per audit report observation and ensure timely NC closure. Maintaining warranty/EFR signoff documents and analyzing the same on timely intervention Maintaining Inspection agreement/ CSR and educating team on the same Monitoring inspection activity as per inspection agreement at final inspection along with Customer Specific Requirement. Monitoring SPC (Statistical Process Control) Monitoring & Improving process capability for product characteristic by using SPC toll to reduce variations. Conducting SPC study of process, setting control limits & training operators to use the same Employee Training & Development Conducting training as per the IATF & QMS requirement. Documenting employee skill & responsibility matrix and training employees for skill improvement. Awareness training to QA Engineers on SPC, MSA & PPAP. Ensure Employee involvement through Kaizen competition by involvement of all QA employees. Job Requirement Work Experience Minimum 10-12 years of experience Industry Related experience:Auto Component Manufacturing Skills and competency: Applicable QMS Standard Good Knowledge of SPC, FMEA, PPAP, 7QC Knowledge of Process and product knowledge Basic SAP 3G (Gemba, Gembutsu, Genjitsu) Control Plan & Inspection Process (Material, In-process & Product) Quality Control Process Documentation & Report Preparation MS Office Analytical Skills Strong Time Management and Priority Management Interpersonal Skill, Problem Solving, Teamwork
Posted 3 months ago
3 - 8 years
3 - 8 Lacs
Panvel
Work from Office
-We are looking out candidates for different sections and positions in Quality Assurance department. Such as IPQA, QMS, Lab QA, AMV QA. Interested candidates can share their resumes on a.salunkhe@v-ensure.com & n32admin@v-ensure.com Role & responsibilities 1) IPQA - In process Checks. - Line clearance - Review of BMR, BPR 2) QMS - Handling and review of Change control, deviations, CAPA of different departments. - Document issuance, archival, retrieval. - Facing the Audits. 3) Lab QA & AMV QA - Managing Analytical QA activities. - Review of documents related to QC i.e. Raw material, finished products, stability. - Review of documents of Method validation, Assay. Preferred candidate profile - Candidates must have experience in Pharma formulation plant. - Must have good communication skills. - Candidates from Regulatory plant will be given preference. - Immediate joiners will be preferred. Perks and benefits Best in the industry
Posted 3 months ago
4 - 6 years
3 - 8 Lacs
Bengaluru, Visakhapatnam, Hyderabad
Work from Office
• Responsible for analytical documents review, filing after approval for: • Batch Analysis • Method Validation and Method Transfers • OOS / OOT Investigations • Stability Protocols, Reports, Data • Certification of standards • Review of Specifications and Test Methods • Review of Calibration and Qualifications of Analytical Instruments • Audit trail review • Should understand all analytical instruments like HPLC, GC, Spectrophotometers, Other analytical instruments • Understanding of good laboratory practices in Quality control and Analytical Development and Validation • Understand 21CFR Part 11 requirements, Audit trail reviews, GMP requirements, ICH guidelines on Specifications, Method validations.
Posted 3 months ago
15 - 20 years
11 - 21 Lacs
Bengaluru, Hyderabad
Work from Office
• Responsible for Operations of Quality control • Implementation of all Quality control procedures, Maintaining and Upgrading systems and processs in Quality control to meet most stringent regulatory requirements (GMP / GLP) • Handling all Regulatory audits, Client Audits, Internal Audits in QC • Planning and coordination for analysis and release of Input, Inprocess, Final products in time • Planning and management of resources for Quality control – Instruments, Chemicals and consumables, Manpower. • Providing all documentation and other necessary support for Regulatory for product registrations and life cycle management from Quality control
Posted 3 months ago
5 - 10 years
5 - 6 Lacs
Bengaluru
Work from Office
Role & responsibilities in Total in in in charge to take as senior Quality Manager/Assurance and handle the entire department Preferred candidate profile Perks and benefits
Posted 3 months ago
2 - 6 years
4 - 5 Lacs
Pune
Work from Office
Job Description Roles and Responsibilities: Demonstrated expertise in Process Quality and Product Validation. Proficiency in PPAP documentation, Line/Process Audit, and Control Plan. Strong knowledge and hands-on experience with PLM Applications. Must have experience with ESD 20:20 and IATF standards. Technical knowledge of PFMEA, SPC, MSA, Poka-Yoke, Kaizen, and 7QC tools. Should have knowledge of Electronic and Mechanical assemblies Educational qualifications with a consistent academic record of 60% or above throughout. Excellent communication skills, with the ability to convey technical information effectively. Preferred Candidate Profile: Diploma/B.Tech (Electrical or E&E) graduate with 2 to 6 years of experience in the Electronic Manufacturing Industry, particularly in SMT and assembly in QA. Preferably from the Electrical/Electronic Manufacturing Industry. Regards , Vasanth Kumar M 90477 44528 (What's app) vasanthkumar.m@haarvard.com
Posted 3 months ago
9 - 14 years
8 - 11 Lacs
Jadcherla
Work from Office
Job Description Overview: We are looking for a meticulous and experienced Production Assistant Manager to spearhead production activities at Evertogen Life Sciences, ensuring seamless manufacturing of tablets, capsules, and other pharmaceutical formulations. In this pivotal role, you will oversee daily production, guaranteeing adherence to stringent quality and GMP compliance standards, including EU GMP, MHRA, US FDA, and WHO guidelines. You will collaborate closely with cross-functional teams such as QA, QC, Warehouse, and Engineering, optimizing processes for enhanced yield, efficiency, and cost reduction. Additionally, you will champion continuous improvement initiatives, lead root cause analysis, and implement corrective actions to mitigate deviations. Your leadership will extend to mentoring production staff, conducting training sessions, and fostering a safe and compliant work environment. You will manage equipment maintenance, raw material inventory, and finished goods effectively, contributing significantly to our commitment to delivering high-quality pharmaceutical products and enhance the predictability of our client's business. This role demands a proactive individual with a strong understanding of pharmaceutical manufacturing and a commitment to upholding the highest standards of quality and compliance. Job Details: Industry: Pharmaceutical Department: Production Role: Assistant Manager Location: Jadcherla Compensation: 11,00,000/Annum Experience Required: 9+ years Employment Type: Full-time Qualification: Bachelor's degree in Pharmacy or related field Responsibilities: Production Planning and Execution Oversee and manage daily production activities for tablets, capsules, and other pharmaceutical formulations to meet production targets. Ensure adherence to the production schedule while meeting quality and compliance standards, adjusting plans as needed to address unforeseen challenges. Coordinate with cross-functional teams such as QA, QC, Warehouse, and Engineering for smooth operations and efficient resource utilization. Monitor production output and identify areas for improvement to enhance overall productivity and efficiency. Implement strategies to minimize downtime and maximize equipment utilization, ensuring continuous production flow. Analyze production data to identify trends and patterns, providing insights for informed decision-making and process optimization. GMP and Regulatory Compliance Ensure all production processes comply with EU GMP, MHRA, US FDA, WHO, and local regulatory guidelines, maintaining a state of audit readiness. Maintain batch manufacturing records (BMR), SOPs, and other documentation as per regulatory requirements, ensuring accuracy and completeness. Ensure a cleanroom environment and adherence to good documentation practices (GDP), promoting a culture of compliance and data integrity. Conduct regular self-inspections and audits to identify and address potential compliance gaps, implementing corrective actions as necessary. Stay updated with changes in regulatory requirements and industry best practices, implementing necessary updates to production processes and documentation. Participate in regulatory inspections and audits, providing accurate and comprehensive responses to auditors' inquiries. Process Optimization and Continuous Improvement Identify and implement process improvements for better yield, efficiency, and cost reduction, leveraging Lean Six Sigma methodologies. Support in validation, qualification, and scale-up of new products and equipment, ensuring smooth technology transfer and successful implementation. Conduct root cause analysis and implement corrective and preventive actions (CAPA) for deviations, preventing recurrence and improving process robustness. Monitor process performance and identify opportunities for optimization, implementing changes to improve efficiency and reduce waste. Collaborate with cross-functional teams to implement process improvements and resolve production issues, fostering a culture of collaboration and problem-solving. Track and measure the impact of process improvements, providing data-driven insights to stakeholders and demonstrating the value of continuous improvement initiatives. People Management and Training Supervise and mentor production operators, technicians, and shift in-charges, providing guidance and support to enhance their skills and performance. Conduct training sessions on GMP, safety, SOPs, and new processes, ensuring that employees have the knowledge and skills necessary to perform their jobs effectively. Maintain a safe and compliant work environment, ensuring all employees follow safety guidelines and promoting a culture of safety awareness. Conduct performance evaluations and provide feedback to employees, identifying areas for improvement and supporting their professional development. Foster a positive and collaborative work environment, promoting teamwork and open communication among team members. Manage employee schedules and ensure adequate staffing levels to meet production demands, minimizing downtime and maximizing productivity. Equipment and Resource Management Ensure proper maintenance and calibration of production equipment such as granulators, compression machines, coating machines, and blenders, adhering to preventive maintenance schedules. Coordinate with the engineering team for troubleshooting and preventive maintenance, minimizing downtime and ensuring equipment reliability. Manage raw material and finished goods inventory to minimize waste and downtime, optimizing inventory levels and ensuring timely availability of materials. Implement strategies to reduce equipment downtime and improve overall equipment effectiveness (OEE), enhancing production efficiency and reducing costs. Monitor equipment performance and identify potential issues, implementing preventive measures to avoid breakdowns and maintain optimal performance. Ensure that all equipment and resources are used efficiently and effectively, minimizing waste and maximizing utilization. General Expectations and Past Experiences: Possess a Bachelors degree in Pharmacy, Chemical Engineering, or a related scientific field with 9+ years of experience in pharmaceutical production. Demonstrated expertise in GMP Compliance and navigating Regulatory Standards (EU GMP, US FDA, WHO). Proven ability in Equipment Operation (Granulators, Compression Machines, Coating Machines, Blenders) and Preventive Maintenance. Strong background in Pharmaceutical Manufacturing Processes and Pharmaceutical Formulations, including Process Validation. Experience with Root Cause Analysis and implementing Corrective and Preventive Actions (CAPA) effectively. Proficient in Production Planning, managing Production Schedules, and optimizing Pharmaceutical Supply Chain. Exceptional Team Leadership skills with a track record of mentoring and developing production teams.
Posted 3 months ago
6 - 11 years
9 - 11 Lacs
Navi Mumbai
Work from Office
1. >6 years experience in Quality assurance 2. Adequate exposure of Internal audits 3. Adequate exposure in external audits NABL, CAP etc 4. Will be on travelling profile 5. Preparing the assigned labs for NABL audits , conducting internal audits 6. Monitoring the assigned labs for Quality assurance, IQC , EQAS, IQC outliers, CV% etc 7. Preparing SOPs , QSPs 8. Should have faced 10+ NABL Audit 9. Should have good team leading skills 10. Should have completed ISO 15189 2022 course Interested candidates can share resume to sanjay.behera@thyrocare.com or whatsapp to 8928285213
Posted 3 months ago
8 - 13 years
15 - 20 Lacs
Udaipur
Work from Office
Job Description We are looking for an experienced Analog Design Engineer with expertise in ADC selection, discrete circuit design, microcontroller integration, power supply design, and PCB design. Skills/Qualification Education: Bachelor's or Master's degree in Electrical/Electronics Engineering or a related field. 7+ years of experience in analog circuit design, PCB layout, and power electronics. Analog Design Expertise: Knowledge of various ADC types and selecting suitable ADCs for AC signal measurement. Circuit Design: Hands-on experience with discrete circuit design using transistors, op-amps, and other components. Microcontroller Selection & Usage: Experience in selecting microcontrollers and utilizing their peripherals effectively. Power Supply Design: Expertise in SMPS design, DC/DC converters, and LDOs. Design for Manufacturability (DFM): Strong understanding of DFM principles and their application in product design. PCB Design: Experience in PCB layout with considerations for EMI/EMC compliance. Component Selection: Proficiency in selecting op-amps, microcontrollers, power switches, transistors, diodes, and capacitors. Quality Tools: Knowledge of 8D, FMECA, CAPA, and Why-Why analysis methodologies. Product Reliability: Understanding of part and product reliability principles. EMI/EMC & Safety Standards: Practical knowledge of safety, EMI/EMC standards and their application. RF Design (Optional): Preferred for projects involving RF applications. Strong analytical and problem-solving skills. Excellent communication and teamwork abilities. Responsibilities Provide upfront technical architecture and high-level design to ensure manufacturability, serviceability, performance, reliability, cost, and feature requirements. Support Program Manager in overall program planning to ensure timely delivery of projects. Actively participate in requirement analysis and preparation of requirement artifacts during the definition phase. Ensure the design supports manufacturability and meets product cost targets by driving design innovation, selecting cost-effective components, and optimizing manufacturing, service, installation, and maintenance costs. Implement best practices such as design before implementation, unit testing, DFMA, FMECA/Fault Tree Analysis, and robust design methodologies to ensure first-time right designs. Accountable for pilot execution as per the program plan and ensure timely closure of pilot actions.
Posted 3 months ago
3 - 4 years
1 - 3 Lacs
Akola
Work from Office
Roles and Responsibilities Conduct vendor audits, root cause analysis, and deviation management to ensure compliance with quality standards. Prepare SOPs for QMS implementation and maintain accurate records of market complaints, CAPAs, and change controls. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Ensure timely completion of tasks related to APQR (Advanced Product Quality Review) and participate in continuous improvement initiatives. Maintain a high level of accuracy in data entry, documentation, and reporting.
Posted 3 months ago
5 - 8 years
4 - 6 Lacs
Hyderabad
Work from Office
Position: QUALITY ASSURANCE (QA) MANAGER Description: The ideal candidate will be responsible for overseeing the quality and safety of our food products, ensuring they meet all regulatory and company standards. This role involves developing and implementing quality assurance policies, conducting regular inspections and audits such as BRCG 9 and FSSC 22000. The QA Manager will work closely with production, procurement, and QC teams to ensure that our products are safe, consistent, and of the highest quality. Verication of HACCP, validation, test methods, updating of SOP's. Preparing customer specications, COA, and other vendor related documentation. Thorough knowledge of Export documentation knowledge related to quality assurance along with CAPA & Root cause analysis. Coordinating with external laboratory testing of FG, PM, Water As per FSSAI and Organic sampling as per APEDA. This position requires a proactive approach to problem-solving and a commitment to continuous improvement. Deliver training programs for sta on quality standards, food safety and hygiene. Stay updated on industry trends and regulatory changes. Develop and implement corrective action plans. Experience: 5-8 years Education Qualification: B-tech / M-Tech Food technology / Msc Biochemistry, Biotechnology, Microbiology, Msc Food Science & Nutrition Industry Type: Agriculture/Biochemistry/Technology /Food technology (Agri-tech) Role Type: Individual Contributor Employment Type: Full Time, Permanent
Posted 3 months ago
2 - 6 years
3 - 6 Lacs
Bengaluru
Work from Office
Job DescriptionJob Description Health, Safety, Security & Environment Executive Work Dynamics About JLL Were JLL. We’re a professional services and investment management firm specializing in real estate. We help organizations around the world achieve their ambitions by owning, occupying and investing in real estate. If you’re looking to step up your career, JLL is the perfect professional home. At JLL, you’ll have a chance to innovate with the world’s leading businesses, put that expertise into action on landmark projects, and work on game-changing real estate initiatives. You’ll also make long-lasting professional connections through sharing different perspectives, and you’ll be inspired by the best. We’re focused on opportunity and want to help you make the most of yours. Achieve your ambitions – join us at JLL! We employ more than 400 HSSE specialists across our Work Dynamics business. Our primary areas of safety focus are in our Facilities Management and Project & Development Services but also encompass wider WD product lines. Until now, our HSSE management has been built around local and regional structures. However, with the increasing globalization of our client base, we are now seeking to implement a global HSSE programme to deliver the global consistency and excellence our clients and shareholders demand and our people deserve. This role will be crucial in ensuring the global programme is implemented across the India sites of our WD Business. Role Purpose As a member of the JLL West Asia HSSE team, this individual will be responsible for implementing and managing HSSE for one of the JLL’s key India WD accounts. The most important objective of this role will be ensuring that our employees and sub-contractors return home safely at the end of their working day. To demonstrate leadership in HSSE management, ensuring that the JLL HSSE and Client Management System and Standards are applied across areas of responsibility. To promote a positive, proactive safety culture and to influence stakeholders and ensure alignment and compliance with all client HSSE related policies and practice. The role is highly visible, and the work is fast-paced focused on ensuring that critical stakeholders, such as employees and clients, receive timely, relevant information and appropriate counsel for HSSE Matters. Successful candidate must have an acute eye for HSSE risk and be able to foster as strong safety culture and deliver world class results, improved productivity and flawless execution. To drive a program for training, audit, measurement and reporting HSSE performance against agreed standards. To implement practical risk management strategies. What this job involves Performance Ensure Client and JLL HSE Procedures are implemented at the Client location Ensure HSE trainings, Mock drills and Tool box talks are conducted Ensure the site and facility operations within the scope of services are in adherence to the applicable HSE regulations Ensure timely reporting of incidents and management of RCA and CAPA. Conduct HSE audit for the site and submit report to the admin team Ensure external/ internal HSE audit points are closed and ensure to avoid recurrence of the audit points Ensure building and services related HSSE risk assessments are in place Manage account specific incident and accident investigations. Support implementation of an effective account HSSE communication plan. Every day is different, and in all these activities, we’d encourage you to show your ingenuity. Sound like you? To apply you need to be / have The Candidate Our ideal candidate will have Ability to influence, partner and operate strategically are critical competencies. Positive, proactive, energetic approach to safety management. Ability to demonstrate initiative and show foresight in relation to existing and potential problems. Evidence of strong interpersonal skills in order to establish credibility with colleagues and senior management and to foster effective working relations with a wide range of senior internal, client and external contacts Knowledge and understanding of Internationally recognized HSSE Management systems Results orientated with a strong focus on the delivery of objectives, including an ability to provide creative and innovative solutions based on a sound understanding of business requirements. Good communication skills, both verbal and written, with ability to deal with all people at all organizational levels, internally and externally. Ability to work unsupervised and take positive action to resolve issues on own initiative. Computer literate with a knowledge of commonly used software programs, including Microsoft Office applications. Ability to research and produce management information and specialist reports making recommendations as appropriate. Good organisational skills with the ability to balance competing demands and to meet deadlines. Strong business acumen. Ability to carry out an audit and gather objective evidence through observation, interview and sampling of documents and records. Strong cultural awareness: unwavering ethical standards; drives excellence and innately collaborative. Understands how to be effective operating across geographies and cultures. Able to lead and inspire, guide and coach, and develop the performance of those managed. Essential Criteria: Minimum 5 years’ experience developing, implementing, and managing HSSE programs Strong track record HSSE management experience within Operational Management systems and working with corporate clients. Appropriate recognized Professional HSSE qualifications and memberships. An agile approach to stakeholder management – able to operate effectively in a matrix structure. A strong orientation to goals and measurable results.
Posted 3 months ago
7 - 11 years
8 - 12 Lacs
Dahej
Work from Office
Drafting and adherence to Quality Assurance Procedures including: Standard Operating Procedures & Work Instructions Change Control Process Validation Document Control. cGMP Compliance Planning and Co-ordination for External and Internal Audits Ensure that CAPA and adhered for Nonconformances Investigate and Review Customer Complaints Training to stakeholders w.r.t. updated procedures and compliances IMS, TQM and 5S Procedures and compliances Desired Candidate Profile Ideal candidate must be a Full Time M.Sc. (First Class) in Chemistry/Industrial Chemistry with 8-11 years of experience in QA Function in a Chemical/API manufacturing plant
Posted 3 months ago
7 - 8 years
3 - 5 Lacs
Mumbai
Work from Office
To support our extraordinary teams who build great products and contribute to our growth, were looking to add a Regional Service Executive located in Mumbai. What a typical day looks like: Daily Work Management of ASPs, and directing engineers and also addressing operational and technical issues, resolving performance bottlenecks, and achieving desired objectives ASP (Authorized Service Partner) Appointments and audits as per the defined process and report the facts and take CAPA. Daily review with ASPs, and the Flex team. Handling installations of scanners, printers, desktops, and Laptops and providing active troubleshooting support for all hardware, software, and network-related problems. To drive day to day operations of ASP's, governing the operations by doing Audits, both process and parts, capacity management of the engineers in line with the call volumes, driving operations for the state to attend daily, weekly operations review meetings Must have understanding of service network, able to identify and resolve ASPs Able to achieve KPIs as per SLAs The experience were looking to add to our team: Technical Degree / Diploma computer/electronics/communication engineering is must Minimum (7-8) years of experience of handling, managing and appointing Service Partner across South India region. Should have experience in handling multiple service outlets Ensuring ASP (Authorized Service Partner) training and enhance their technical skill level Providing technical training to regional ASP Demonstrating new product to ASP Technical Audit
Posted 3 months ago
1 - 2 years
2 - 3 Lacs
Chennai, Ahmedabad, Bengaluru
Work from Office
Batch Charging and Manufacturing, CGMP compliance, BPR compliance
Posted 3 months ago
6 - 8 years
8 - 10 Lacs
Pune, Chakan
Work from Office
Implement & maintain Quality Systems, Establish Q policy that align with Organization goals., Oversee plant QA activities, Internal Audits & compliance, CAPA, training & awareness, Supplier Q management Desired profile of the candidate: Responsible for all QA activities, Maintaining customer PPM , People awareness, Maintain in-house PPM
Posted 3 months ago
3 - 8 years
2 - 7 Lacs
Pune
Work from Office
Role & responsibilities : - Ensure compliance of all products at all stages as per drawing and customer requirements - Verification and record product quality as per standard operating procedure to ensure product comformance - Monitoring of the status of latest design changes implementation with a co-ordination development and production team - to ensure operation of mistake / error proofing at decided stage , daily verification - To provide technical support to plant , resolve the issue - To conduct Product , process verification and validation - Improve internal , external , production and quality performance - Compliance of customer audit , certification audit requirements - Material and instrument verification - New material inspection - Conduct PDI (Pre-Dispatch Inspection) & prepare the report for the same - Material verification according to drawing - Line rejection verification - Lay-out inspection as per plan - On line trial observation - Material verification - Non-Confirming Product Analysis - Control on rework , repair product - To implement statistical techniques (MSA, SPC etc). - Responsible for maintaining Quality records of the department - To identify the problem related to Product, Process and Quality System and initiate the corrective action for the same - Initiate action to prevent the occurrence of any non conformities relating to product, process and quality system. Follow EOHS related Norms / Requirement at QA activities Preferred candidate profile : Injection Molding Perks and benefits : EPF, ESIC, Bonus, Canteen etc.
Posted 3 months ago
2 - 6 years
3 - 5 Lacs
Ahmedabad
Work from Office
Role & responsibilities 1. To maintain and ensure the cGMP compliance. 2. Preparation of MPCR, PVP, PVR, HSP & HSR based on TTD. 3. Preparation of proposed commercial MPCR based on marketing requirements. 4. Raw material tracking for the smooth functioning and timely execution of the products. 5. QMS related activities (CRF/Deviation/Investigation/CAPA) and compliance. 6. Follow up for CRF approval. 7. Creation of HALB code and preparation of BOM in SAP 8. Compilation of validation documents like Process validation report and Hold time study report. 9. Any other job assigned time to time by superiors. Preferred candidate profile US Market experience in ANDA filing, CMC documentation, regulatory compliance, and technology transfer. Perks and benefits As per company policy
Posted 3 months ago
7 - 8 years
5 - 7 Lacs
Pune, Pimpri-Chinchwad
Work from Office
Job Title: Quality Assurance Manager Industry: Rubber Manufacturing Experience: Minimum5 years in the rubber industry Qualifications: Bachelor's degree in Engineering, Quality Management, or a related field. Minimum of 5 years of relevant experience in quality assurance within the rubber industry. In-depth knowledge of IATF (International Automotive Task Force) and ISO standards related to quality management systems. Proven experience in conducting and managing internal and external audits, with a strong focus on ISO and IATF requirements. Technical training and certification in Six Sigma methodologies. Familiarity with VDA (Verband der Automobilindustrie) standards and practices. Responsibilities: Quality Management Systems: Develop, implement, and maintain a robust Quality Management System (QMS) in accordance with IATF and ISO standards. Ensure compliance with all relevant regulations and standards governing quality in the rubber industry. Audits and Compliance: Plan and conduct internal audits to verify compliance with established quality procedures and standards. Coordinate external audits and certifications, ensuring the company's adherence to IATF and ISO requirements. Take corrective actions and preventive measures based on audit findings. Continuous Improvement: Drive continuous improvement initiatives to enhance overall product quality and operational efficiency. Utilize Six Sigma methodologies to identify areas for improvement and implement effective solutions. Supplier Quality Management: Collaborate with suppliers to establish and maintain high-quality standards for raw materials and components. Conduct supplier audits and assessments to ensure adherence to quality specifications. Training and Development: Provide technical training on quality assurance principles, IATF, ISO standards, and Six Sigma methodologies. Foster a culture of quality awareness and continuous improvement among team members. Data Analysis and Reporting: Analyze quality data and metrics to identify trends and areas for improvement. Prepare and present regular reports to management, highlighting key quality performance indicators. Customer Satisfaction: Monitor customer feedback and implement measures to address concerns and enhance customer satisfaction. Collaborate with cross-functional teams to ensure customer requirements are met consistently. Regulatory Compliance: Stay informed about changes in industry regulations and standards, and ensure the company's compliance with relevant requirements. Leadership and Team Management: Lead and mentor the quality assurance team, fostering a culture of accountability and excellence. Collaborate with other departments to ensure a cross-functional approach to quality management. Key Skills: Strong leadership and communication skills. Analytical mindset with a focus on data-driven decision-making. Problem-solving and root cause analysis expertise. Proficient in the use of quality tools and methodologies, including Six Sigma. Excellent knowledge of IATF and ISO standards. This job description outlines the key responsibilities and qualifications expected of a Quality Assurance Manager in the rubber industry with a minimum of 7 years of experience. Adjustments can be made based on specific organizational needs and industry nuances.
Posted 3 months ago
9 - 12 years
0 - 0 Lacs
Navi Mumbai, Khopoli
Work from Office
1) Conduct comprehensive assessments of potential vendors, including reviewing operational capabilities, certifications, quality control processes 2) Perform site audits, inspections, and assessments of suppliers' Required Candidate profile 1) Preparation of vendor audit report & reviewing CAPA received from vendor 2) Collect and evaluate necessary documentation 3) Preparation of vendor audit report
Posted 3 months ago
9 - 12 years
27 - 35 Lacs
Mumbai
Work from Office
CQA Deputy Manager Domnic Lewis has been mandated to hire forCQA Deputy Manager Key Responsibilities : Conduct Vendor Audits for Raw Materials and Packaging Materials. Plan and prepare the vendor audit schedule; coordinate with the Purchase team for efficient execution. Review and evaluate vendor qualification documents, including Vendor Questionnaires, Audit Reports, Quality Agreements, DMF, and all related declarations. Address and resolve regulatory queries as required. Present Vendor Qualification Documentation and Systems during Regulatory Inspections and Customer Audits at the manufacturing sites. Support investigation of market complaints and track CAPA (Corrective and Preventive Actions). Required Skills : Strong knowledge of current regulatory requirements. Familiarity with Good Warehouse Practices (GWP) and Good Distribution Practices (GDP). Proficient in Microsoft Office Suite, Excel, SAP, and Document Management Systems (DMS). Excellent communication, listening, and managerial skills. Willingness to travel as required. Qualifications : B. Pharm, M. Pharm, or M. Sc. in a relevant field. Experience : Minimum 9-12 years of experience in Quality Assurance, with a focus on vendor qualification and regulatory compliance.
Posted 3 months ago
1 - 6 years
2 - 5 Lacs
Vadodara, Ahmedabad, Anand
Work from Office
Responsible perform/Report the analysis of Water and pure steam (Condensate) samples. Responsible for preparation of Standard operating procedures, Standard test procedures, specifications ,SOP, STP, Specification, ATDS CoA of the RM, PM, Consumable Required Candidate profile change control /deviation / OOS / OOT / OOC/CAPA. Analytical method transfer/Stability Protocols Report the analysis of Finished Product, In- IP, SFG, FP. Perform the analysis as or when required
Posted 3 months ago
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