842 Capa Jobs - Page 14

Manage RM/SFG/FG specs Ensure effective RCA/implement CAPA wherever required Oversee QMS/FSSC/BRC systems concerning GMP/ labs Lead ISO 17025/NABL accreditation Ensure FTR performance Maintain 5S practices in the lab Required Candidate profile 12+ years in leading QC function in food companies . Job location is Kochi, Kerala Exp in leading teams of size 10+

Job Overview To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing. Competencies Plan, perform, and document Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) for raw materials, intermediates, and finished drug products. Prepare and review protocols and reports related to method validation/verification/transfer in alignment with ICH guidelines. Coordinate with R&D, AR&D, QA, RA, and manufacturing units for method transfer and troubleshooting activities. Perform routine and non-routine analysis using HPLC, UPLC, GC, UV, IR, dissolution apparatus, and other analytical instruments. Ensure timely qualification/calibration of instruments used in AMV lab. Review analytical documents like raw data, chromatograms, validation reports, SOPs, etc. Support regulatory inspections (USFDA, EU, ANVISA, WHO, etc.) and respond to queries related to AMV/AMT. Investigate OOS/OOT/Deviation/Incident related to AMV activities and provide effective CAPA. Maintain GLP and cGMP compliance across AMV operations. Experience: 4 -5 years in QC-AMV in a regulated pharmaceutical environment Qualifications M.Sc. (Chemistry/Analytical Chemistry) / M.Pharm

Responsible for maintaining GLP and GDP in QC department. Review of SOPs, Specifications and STPs. Identifying training needs of the staff in the QC department. Ensuring that all Analytical Instruments are in good working condition Ensure and maintain AMC / Calibration / Qualification schedule and status of QC Instruments / Standard Weight and other measuring instrument and timely completion of the same as per the schedule. Up keeping the laboratory all the time ready for regulatory and customer audits. Responsible for QC QMS Activity i.e Lab Incident, Deviation, OOS, OOC, CAPA for their timely initiation, investigation and closer. Compliance for maintaining Working Standard and Reference Standard in the lab. Ensure and verification of Log Books / Analytical Documents and online documentation in the lab. Compliance for Columns / Chemical / Volumetric Solution / Reagent Solution management Compliance for Instrument Tags / Labels/ QC Status Board / NABL analysis Responsible for maintaining and continuous improvement as per ICH Q7 A and relevant regulatory guidelines. Ensuring a safe environment is maintained in the laboratory. Regularly provide the training to the QC Colleagues on SOP, GMP and GLP. Ensure the Analytical Method validations as well method transfers are conducted with an approved protocol and duly documented and approved. Present GLP and GMP related activities in the weekly review meeting and monthly review meeting to the Senior management. Regularly supporting and providing the data as per the requirement from customer and regulatory. Develop & prepare work procedures to minimize OHS risks and Adverse Environmental Impact. Involve the regulatory and customer audits to provide the answers for queries Ensure the data integrity checks are conducted regularly to evaluate the health of the Quality system and implement actions as required. Control and issuance of loose formats and hard books. Preparation and review of Standard Operation Procedures, Specification, Test method and Quality control procedures. Responsible for review and release of batches-QC analytical Documents. Responsible for approval and release of products for Dispatch. As and when additional responsibilities arise, same shall be taken based on the requirement. Qualifications BSC / MSC / B Pharmacy / M Pharmacy

To review validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers. To review the process validation/ cleaning validation qualification protocols. To review SOPs, batch manufacturing and packing records, specifications, and test methods of the products. To monitor, control and review deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety Quality management system. To ensure that all critical equipment and utilities that are used to manufacture the product are under qualified status, calibrated and are under routine preventive maintenance program. To ensure proper investigation of market / customer / regulatory complaint by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify effectiveness of CAPA periodically. To evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures, that each production batch complies with the provisions of Food safety standards (FSS) act and other legal, customer and regulatory requirements. To ensure compliance to the regulatory, customer, legal requirements and face audits and comply non-conformities observed during the audits. To ensure compliance to the current ISO 9001, DC Act, FSS Act 2006, FSSC 22000 (including HACCP), FAMI-QS, WHO-GMP and other customer and regulatory requirements. To carry out self inspections and ensure compliance to the audit observations of manufacturing, testing, warehousing facility. To ensure completion of APRs of products and take appropriate actions in case of deviations. Recommendation to recall approving authority on product recall, review, and disposition of recalled and returned goods. Handling of online and in process rejections and take appropriate actions to avoid the recurrences and disposition. To co-ordinate with CQA for up gradation in the SAP systems as per any changes or new product at Mahad site. To monitor stability of products, control sample storage and compilation of analytical reports and take appropriate action in case of failures. To identify and provide resources with co-ordination with other departments to carry out quality functions effectively. To liaison with regulatory authority for new product permissions, licenses and renewals, certificates, and approvals. Ensuring implementation and execution requirements of food regulations for export market (US)-21 CFR Part 110 111. Ensuring avoidance of breach of data integrity at all the levels. Ensuring implementation of effective sanitation activities at all the levels. Imparting required training to shop floor personnel. Adherence to the requirements of EHS norms. To raise the PR for procurement of miscellaneous items, external trainings, certification fees and capex related items. To sign the Excess Material Requisition, LRA notes, BMR return notes and other QMS documents in absence of Head- QA. To perform MSC2N transactions in SAP. Review of Change Control, Deviation, CAPA in trackwise. Implementation and execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset). SOP, BMR/BPR, layouts, STP review and approval in ENSUR system. To conduct vendor audits for RM/PM. To lead and guide the IPQA team for shopfloor activities. To set, review and evaluate KRA of reportees. To share the RR nominations of team members on quarterly basis. To identify and implement the OE projects. Patient/ Customer centricity. Qualifications B. Pharm/ M. Pharm

Please share your CV on sneha.shinde@embio.co.in or kchoudhary@embio.co.in for further process.

We are looking for an experienced and detail-oriented Quality Assurance (QA) professional to oversee and maintain the quality management system and ensure compliance with statutory and customer standards. Responsibilities: Prepare and maintain all quality manuals, process documents, and standard operating procedures (SOPs). Review and approve process, quality control, maintenance manuals, and batch/lot releases. Investigate deviations, failures, non-conformances, out-of-specification results, and customer complaints; implement corrective and preventive actions (CAPA). Ensure calibration and maintenance of all instruments and test equipment used for inspection and testing. Ensure compliance with statutory and regulatory standards such as ISO and other applicable guidelines. Oversee validation of processes, analytical methods, and equipment, and review validation reports. Approve analytical reports for finished products, ensuring conformity to standards and customer specifications. Maintain proper control over the use of product labels in line with statutory requirements. Ensure proper inspection and test status of all materials in accordance with laid-down procedures. Conduct internal audits for quality systems, monitor corrective actions, and ensure closure. Conduct training programs to enhance quality awareness among staff. Desired Candidate Profile: Proven experience in quality assurance/quality control in [insert industry, e.g., pharma, FMCG, etc.]. Strong knowledge of quality management systems, ISO standards, GMP/GLP compliance. Excellent problem-solving, analytical, and communication skills. Ability to lead internal audits and drive a culture of quality compliance.

Quality with experience in QMS, CAPA, calibration, Kaizen, Lean, CTQ monitoring, and ISO/IMS systems. Should handle FG inspection, NPD validation (FAR), audits, data analysis, and drive continuous improvements. Must be available for Direct Interview.

Position : Senior Executive-Quality Management. Location : PU Kalyani Qualifications : M.Sc/B.Pharm or equivalent Experience : 5-8 years of hands-on experience in the Pharmaceutical industry specifically covering QMS activities in manufacturing facilities API, Quality Control analysis, Investigations and Validation. Reporting to : Sr. Manager Quality Management Job Summary : He/she will be responsible for handling of QMS activities in API manufacturing as well as analytical laboratory. This role involves ensuring adherence to regulatory requirements, managing QMS projects and having good knowledge to evaluate the adequacy of scientific justification, root cause determination and CAPAs proposed in Manufacturing as well as Laboratory investigations. The ideal candidate should have extensive experience for QMS-related activities in API Manufacturing sites (Non-sterile/sterile) within the pharmaceutical industry. Key Responsibilities: •To establish and follow the process to assure that investigations at the site are aligned with respective site SOPs and to evaluate the adequacy of the scientific justification, root cause determination, and CAPAs proposed in response to investigation findings. •To monitor compliance with data integrity standards at the manufacturing site by performing regular inspections focused on data integrity checks, challenging the site procedures for data integrity compliance, random review of batch manufacturing records, analytical records, paper-based raw data, electronic data & audit trails. •To provide support for site readiness for regulatory inspections by technical & quality inputs through regular visits and checks. •Handling of events and change controls in KabiTrack-related FKOL Kalyani. •Assessment of change controls and review of documents in document management system, related to FKOL Kalyani. •Proficient in conducting/Reviewing/leading team responsible for Audit trail review, Preventive maintenance, performance monitoring, inventory management, user management, Backup & restoration etc for GxP systems. •Implement and maintain data integrity measures, focusing on ALCOA+ attributes. Define policies to improve data security, system security to enhance compliance. •Proficient in drafting, review of GxP document as part of ongoing Quality management systems activities as per assigned role. Skills : oStrong understanding of USFDA, EMA, MHRA, and other regulatory requirements. oFamiliar with ICH, 21CFR Part 210/211/11, EU-GMP, PIC/S GMP and other regulatory requirements. oGood Knowledge of Quality Management Systems and current quality trends oGood exposure in QA functions of production units Strengths: oProven regulatory compliance expertise. oEffective communication, with strong analytical, interpersonal, and problem-solving skills. Takes initiatives, ownership, and responsibility of assigned activities. oGoal oriented, Self-driven with strong commitment to work. oStrong report writing, reading, presentation, and investigational skills.

Role & responsibilities 1. Conduct incoming inspection of raw materials and components as per quality standards. 2. Perform in-process and final inspections on manufactured parts/products. 3. Use various measuring tools and equipment such as Vernier calipers, micrometers, gauges, etc. 4. Identify and report any non-conformities and assist in root cause analysis (RCA). 5. Collaborate with production and design teams to ensure quality issues are addressed promptly. 6. Support audits (internal and external) and assist in documentation such as 4M change records, inspection reports, control plans, etc. 7. Ensure adherence to 5S, ISO/IATF quality standards, and safety guidelines. 8. Provide feedback and suggest improvements for continuous process and product quality. Preferred candidate profile 1. Diploma / B.Tech in Mechanical. 2. Experience in a automotive manufacturing company preferred. 3. Must have good communication skills. 4. Familiar with mechanical drawings and basic GD&T (Geometric Dimensioning & Tolerancing). 5. Knowledge of tools like Vernier, micrometer, height gauge, and other inspection tools. 6. Basic understanding of ISO 9001 / IATF 16949 quality systems. 7. Good communication and documentation skills. 8. Attention to detail and strong problem-solving skills. 9. Familiarity with PPAP, FMEA, CAPA processes. (preferred)

Implement a unified Quality Vision & Strategy Manage quality heads in India & USA Ensure adherence to India & US-specific quality requirements Drive zero-defect culture, implement Lean Six Sigma &TQM practices Lead all audits Develop KPIs &dashboards Required Candidate profile - Good Edu - SSBB/TQM/ISO certifications - Deep understanding of Quality principles & Laws - Must have good experience in **India & USA** Quality standard, processes & reporting - Great communication Perks and benefits Great Opportunity in growing organization

ROLE:- Resolve customer complain To ensure technical support to QC, Production, for Quality complaint. To coordinate with Marketing for need of business/customer development requirements. To ensure Customer complaint is resolved in shortest possible time (Target: Max 1 month) and ensure all 4 factors are adequately closed. Disposal line action Corrective Action taken / planned Preventive action taken/ planned Root Cause Analysis To visit customers to resolve complaint, if complaint is serious in nature. In this process, understand as to how customer is carrying out application. Prepare a data base on application of a particular product and its application Organise CAPA meetings for review. Prepare the minutes and circulate Timely generation of MIS for MRM review To ensure timely preparation of PBL: (a) MRM (b) Review Meeting Technically support completion of corrective action to liquidate SM / NM / NC / FG & RMs to make it saleable To workout, implement & monitor to transform Non-Moving /Non-standard material to saleable products in the same business line or across all the available business lines. To follow up with marketing for final realisation of values from these materials. To improve knowledge & skill through training To attend important seminars/conferences for self & team members. Ensure completion of training programmes as identified for skill development with the support from HR & Management. To upgrade resources and ensure most effective resource utilisation. Requirement: - Interpersonal Skills Demonstrated strong leadership, team building and advanced coaching skills Demonstrated ability to motivate people, assess and develop employee skills Ability to work with teams and lead decision-making processes in a team environment Excellent interpersonal communication and listening ability Management Skills Excellent planning and organisational skills, with the ability to balance NSBM correction & customer complaint correction A strong ability to be adaptable and flexible Strong analytical and decision-making skills Highly motivated, results oriented, driven

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

Career Area: Manufacturing : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you'rejoining a global team who cares not just about the work we do but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don'tjust talk about progress and innovation here we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Role DefinitionPerforms advanced inspection and audits to track, analyze, and report on materials, processes, and products to ensure conformance to company's quality standards. Responsibilities Conducting measurement systems analysis; gathering, analyzing, and communicating non-conformance data. Analyzing non-conformance data and maintaining quality system documentation. Interacting with manufacturing team members to determine root cause of quality issues and ensure that corrective and preventive action is implemented. Identifying, analyzing, and resolving non conformance. Investigating problems on worked purchased finished, rough, and interplant material. Coordinates various Quality training programs. Degree RequirementDegree or equivalent experience desired Skill DescriptorsQuality ManagementKnowledge of quality management methods, tools, and techniques and ability to create and support an environment that meets the quality goals of the organization.Level Basic UnderstandingExplains the purpose and limitations of quality management. Accesses organizational resources that enable quality management. Defines quality management concepts. Cites examples of organizational quality management initiatives. Accuracy and Attention to DetailUnderstanding the necessity and value of accuracy; ability to complete tasks with high levels of precision.Level Working KnowledgeAccurately gauges the impact and cost of errors, omissions, and oversights. Utilizes specific approaches and tools for checking and cross-checking outputs. Processes limited amounts of detailed information with good accuracy. Learns from mistakes and applies lessons learned. Develops and uses checklists to ensure that information goes out error-free. CollaboratingKnowledge of collaborative techniques; ability to work with a variety of individuals and groups in a constructive and collaborative manner.Level Basic UnderstandingDemonstrates a basic understanding of the concept of collaborative processes. Explains the concept of collaboration as applicable to organizations. Provides examples of how collaboration has helped achieve organizational goals. Contrasts collaborative with competitive operating styles in organizations. Flexibility and AdaptabilityKnowledge of successful approaches and techniques for dealing with change; ability to adapt to a changing environment and be comfortable with change.Level Working KnowledgeAdjusts to new or changing assignments, processes, and people. Demonstrates willingness to listen to other opinions. Provides examples of shifting from task to task. Identifies and considers alternative approaches to situations or problems. Accepts new or radical ideas with an open mind; avoids snap reactions. Problem SolvingKnowledge of approaches, tools, techniques for recognizing, anticipating, and resolving organizational, operational or process problems; ability to apply knowledge of problem solving appropriately to diverse situations.Level Basic UnderstandingExplains the value of a disciplined approach to problem solving. Describes problem reporting and escalation practices. Utilizes accepted procedures for problem analysis and resolution. Identifies key aspects of problem-solving techniques used in own area. Manufacturing Standards, Procedures and PoliciesKnowledge of organizational standards, procedures and policies in manufacturing activities; ability to plan, guide, and monitor manufacturing processes for compliance.Level Basic UnderstandingDiscusses the relevance of standards for a manufacturing environment. Researches process and product blueprints for own area. Describes and follows all policies, standards and procedures. Obtains documentation and information on standards and their usage. Root Cause Analysis (RCA)Knowledge of the concepts, principles and techniques of root cause analysis (RCA); ability to use a structured approach to identify the causes of undesirable consequences in a manufacturing environment and the changes needed to prevent recurrences.Level Working KnowledgeUtilizes RCA techniques, such as Flowchart, Fish-bone Diagram, etc., to investigate basic problems, determine the causes, and find resolutions. Locates factors that resulted in harmful outcomes of one or more past events. Pinpoints behaviors, actions, inaction, or conditions that need to be changed. Extrapolates lessons to be learned to promote the achievement of better consequences. Practices RCA as an iterative process. This is intended as a general guide to the job duties for this position and is intended for the purpose of establishing the specific salary grade. It is not designed to contain or be interpreted as an exhaustive summary of all responsibilities, duties and effort required of employees assigned to this job. At the discretion of management, this description may be changed at any time to address the evolving needs of the organization. It is expressly not intended to be a comprehensive list of essential job functions as that term is defined by the Americans with Disabilities Act. Relocation is available for this position.

1. >2 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 Interested candidates share CV to sanjay.behera@thyrocare.com or whatsapp to 8928285213

Responsibilities: Jaipur Domicile Only Conduct process inspections per IATF16949 & VDA6.3 standards Implement Lean Six Sigma methodologies for continuous improvement Lead CAPAs, root cause analysis, and corrective actions Annual bonus

Position Overview : We are seeking a skilled and strategic-minded General Manager to lead our External Manufacturing division. The successful candidate will play a pivotal role in coordinating and optimizing our external manufacturing operations, ensuring seamless collaboration with partners, and maintaining the highest standards of quality, compliance, and efficiency. Key Responsibilities: Coordinate and facilitate effective communication between third-party vendors and internal stakeholders to ensure the fulfillment of company requirements and timely query resolution. Review production plans and coordinate with demand planning, supply planning, and Contract Manufacturing Organizations (CMO). Circulate production plans to vendors and oversee their timely execution in alignment with export requirements. Monitor and proactively manage the quality of Ryvis Pharma products, implementing measures to prevent any quality issues that may arise. Explore alternate vendor development options for critical SKUs. Create purchase orders for materials and services needed for production. Lead efforts for packaging changes and product improvements in collaboration with relevant teams. Manage the end-to-end coordination of goods dispatch and QA release, addressing any associated queries and concerns. Take ownership of coordinating and resolving queries raised by the QA team. Facilitate CMO site audits and ensure compliance with standards. Manage market complaints by coordinating between CMO sites and our QA team, including investigating reports and implementing CAPA arrangements. Oversee the creation of product codes and vendor codes. Manage product shifts between CMO units, including evaluation, QA, and R&D approval, as well as site-to-site product transfers. Collaborate with internal stakeholders to prepare and release new artworks in response to changing regulations. Coordinate with vendors and arrange necessary documents for the company's tender business. Initiate change controls for CMO products and maintain vendor records. Coordinate supplier payments, resolving invoicing, taxation, and other discrepancies. Analyze cost sheets, validate prices, negotiate with third parties, and finalize rates. Ensure the timely delivery of committed products to support monthly sales closing. Generate monthly MIS reports for sales and purchase details of third-party products. Maintain and update the CMO Material Master Product List and Vendor Master List monthly. Identify opportunities for cost savings against the budget and implement necessary measures. Proactively manage product risks to ensure continuous alignment with business requirements and supply. Qualifications: Bachelor's degree in Pharmaceutical Sciences, or related field. An advanced degree (MBA, MSc, PhD) preferred. Proven experience (10+ years) in pharmaceutical manufacturing, with a focus on external manufacturing and/or loan license manufacturing. Strong understanding of cGMP regulations and global regulatory requirements for pharmaceutical manufacturing. Demonstrated experience in managing external partners and contract negotiations. Exceptional leadership skills with the ability to inspire and lead cross-functional teams. Excellent communication, interpersonal, and problem-solving skills. Strategic thinker with a track record of driving process improvements and operational excellence. Ability to thrive in a fast-paced, dynamic, and evolving pharmaceutical industry. Experience: Experience in managing supplies of more than 100 finished goods from multiple CMO sites. Experience in implementing multiple projects at CMO sites. Experience in managing production for export orders. Benefits: Competitive salary commensurate with experience. Opportunity to work in a senior management role within a rapidly growing pharmaceutical company. Collaborative and dynamic work environment. If you are a results-driven professional with a proven track record in pharma external manufacturing and are excited to take on a leadership role, we encourage you to apply. Please send your updated CV along with the requested details to hrdept@ryvispharma.com Age: Qualification: Current Company: Current Designation: Current CTC: Expected CTC: Years of Experience: Notice Period: Current location: Reason for Job Change:

Role & responsibilities Oversee and manage the entire manufacturing process. Handle Granulation, Compression , Coating and all other production related activities. Active calculation, dispensing of Raw Materials and batch reconciliation at various stages. In process checking at various intermediate stages of Granulation, Compression and Coating. Prepare IQ, OQ, & PQ of the process & utility equipment. Should handle process of validation batches Ensure online documentation of production activity on timely basis. Review of batch manufacturing record and other related documents for its completion of intermediate and final stage. Maintain the SOPs, Log books and other documents. BMR / BPR preparation in ERP and review.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Seminar / Presentation / trainings/ Management Review Meeting (MRM) etc. internally to achieve QMS Coordination for Technology Transfer Document (TTD) review and new product initiation. Reviewing and approving validation protocols and reports Approving intermediate and API contract manufacturers Ensuring that all Quality related complaints are responded as per SOP Review and Coordination for Batch Processing and packing record. Review of Quality Manual / VMP / SMF. Preparation and review of external audit responses then proposed CAPA monitoring. Maintaining Updated documents as per standard of ISO 9001:14001. Maintaining documents as per USFDA, CGMP, and other regulatory guidelines requirements. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline Any other activities assigned by reporting manager.

We are looking for a highly skilled and experienced Quality Manager to lead and oversee all quality assurance activities in our manufacturing unit. The ideal candidate will ensure that products meet quality standards and regulatory requirements

Manage the Quality Assurance function at manufacturing site Ensure compliance with ISO, GMP & REACH standard Develop, implement & monitor Quality Management Systems including SOPs, documentation & CAPA systems Handle customer complaints, conduct RCA Required Candidate profile 8–12 years of experience in QA, preferably in specialty chemicals Knowledge of analytical instruments, QC processes & technical documentation Strong knowledge - ISO 9001, GMP & other quality standards

Posted On 03rd Apr, 2025 : Role Overview: The Quality Head will be responsible for defining, implementing, and maintaining world-class quality assurance strategies across manufacturing operations, supplier quality, regulatory compliance, and injection molding processes. The role requires strong leadership, analytical thinking, and expertise in industry best practices to promote a strict quality control culture within the organization. Key Responsibilities: Quality Strategy & System Implementation Develop and implement Quality Assurance (QA) and Quality Control (QC) systems aligned with ISO 9001, ISO 14001, ISO 45001 (Occupational Health & Safety), and ESD S20:21 (Electrostatic Discharge Protection). Define and drive KPIs for quality performance, including First Pass Yield (FPY), Defect Per Million Opportunities (DPMO), and Cost of Poor Quality (COPQ). Establish and ensure strict adherence to Standard Operating Procedures (SOPs) for inspection, testing, and validation at every stage of production. Promote a strict quality control culture across all teams, ensuring that every employee understands the importance of quality in manufacturing. Manufacturing of LED TVs, Injection Moulding & Supplier Quality Management Oversee incoming (IQC), in-process (PQC), and final product quality (OQC)to minimize defects and rework. Implement Electrostatic Discharge (ESD) Protection (ESD S20:21) measures to ensure the safety and reliability of electronic components. Work closely with suppliers to improve the quality of raw materials, plastic components, and electronic parts. Conduct supplier audits and enforce compliance with RoHS, REACH, and BIS standards. Manage and optimize injection molding quality control, including: Material selection and testing (resins, polymers). Process parameter optimization to minimize defects such as warping, sink marks, and short shots. Implementation of real-time monitoring and defect detection technologies. Ensuring compliance with industry best practices for plastic components used in electronic products. Compliance & Certifications Ensure compliance with ISO 9001, ISO 14001, ISO 45001, BIS, RoHS, CE, FCC, and other global regulatory requirements. Lead internal and external audits for regulatory approvals and maintain all necessary certifications. Develop and maintain safety and environmental management systems aligned with international best practices. Customer Quality & Market Feedback Analyze customer complaints, warranty claims, and field failures to identify trends and implement Corrective and Preventive Actions (CAPA). Drive continuous improvement initiatives to reduce product returns, warranty costs, and customer dissatisfaction. Collaborate with the after-sales service team to track product performance and reliability in the field. Continuous Improvement & Innovation Implement Lean, Six Sigma, and Kaizen methodologies to drive continuous quality improvement. Introduce automation and AI-based quality inspection techniques to enhance production efficiency. Develop and conduct regular training sessions to ensure all employees, from factory workers to management, understand and adhere to quality standards. Promote a zero-defect mindset within the organization, ensuring proactive rather than reactive quality management. Key Qualifications & Experience: EducationBachelors/Masters degree in Engineering (Electronics, Mechanical, Manufacturing, or Polymer Science). Experience12+ years in Quality Management, preferably in electronics, home appliances, or automotive manufacturing. Expertise in ISO 9001, ISO 14001, ISO 45001, ESD S20:21, Six Sigma (Green/Black Belt preferred), and SPC (Statistical Process Control). Experience with BIS, RoHS, CE, FCC, and other regulatory standards. Hands-on experience in injection molding quality control, defect analysis, and process optimization. Knowledge of AI-based quality inspection, ERP & Quality Management Software (SAP, MES, etc.) is a plus. Key Skills Required: Strong analytical and problem-solving skills (Root Cause Analysis, 8D, FMEA) Leadership and team-building experience in a factory setup Knowledge of global quality management systems Injection moulding quality control & process optimization Experience with ERP & Quality Management Software (SAP, MES, etc.) Ability to collaborate with R&D, Manufacturing, and Supply Chain teams Why Join Be a part of a fast-growing company with innovation-driven leadership and legacy. Opportunity to implement cutting-edge quality processes in electronics and injection molding. Work with a dynamic and high-impact team in a competitive industry. Key Skills : Company Profile Company is ---s most trusted and leading ODM/OEM brand with a complete Made in --- design, development, and manufacturing process. Established in 1984, is one of ---s leading ODM/OEM manufacturers with four decades of industry expertise. As the official ODM for webOS TV in --- and the only TV ODM with a Dolby License, the company focuses on backward integration to optimize costs and enhance production. With a current manufacturing capacity of 1.4 million units per annum, expanding to 3.2 million with a new facility, Company is set to become a major player in ---s electronics manufacturing sector. Its expertise in hardware and software enables it to deliver high-performance products, reinforcing ---s global technology manufacturing capabilities.

Job Summary: We are seeking a meticulous and dedicated In-Process Quality Inspection Specialist to join our 2W Electric Bike Manufacturing team. The selected candidate will play a crucial role in ensuring the quality of electric bikes by conducting detailed inspections on the production line, focusing on critical components such as the battery. Key Responsibilities: Quality Inspection: Conduct thorough inspections of electric bikes at various stages, with a specific focus on the battery components. Ensure that components meet specified quality standards, safety regulations, and design specifications. Knowledge on Visual , Functional, Electrical & dimensional inspection of parts. Good knowledge in problem solving tools ( 7 QC tools , 8D , why why analysis, CAPA ) Defect Identification: Identify and document any defects, deviations, or non-conformities related to the battery during the production process. Work collaboratively with production teams to address and resolve quality issues promptly. Determine root-cause of deviations non-conforming results and implement appropriate corrective and preventive measures. Documentation: Maintain accurate and detailed inspection records, including photographs and written reports for the battery components. Compile and analyse data to identify trends and areas for improvement. Review production records in relation to quality compliance. Daily closure report 0 @ QDC ISO documentation compliance and record management. Process Monitoring: Monitor and evaluate production processes related to battery components to proactively identify potential quality issues. Collaborate with production teams to implement corrective and preventive actions. Good knowledge on Cell technology and function parameters like IR, Cell dimensions, Nominal voltage, SOC , C-Rate, OCV etc Good knowledge on Battery pack assembly, BCDS (Battery charge- Discharge process), Safety requirement, BCT. Responsible to monitor assembly as per SOP, Process check sheet, OPL etc Good knowledge on testing equipment / Methodology used for Battery. 4M confirmation @ unskilled manpower Training evaluation of unskilled manpower Collaboration: Work closely with cross-functional teams, including production, engineering, and quality assurance, to drive continuous improvement in the quality of battery components. Provide feedback to relevant teams on ways to enhance the overall manufacturing process. Training: Conduct training sessions for production line workers on quality standards and inspection criteria specific to battery components. Ensure that the production team is aligned with and understands quality requirements for these critical components. Audit Support: Assist in internal and external quality audits by providing necessary documentation and insights into the in-process quality controls for battery components. Role & responsibilities

Supports experienced Sourcing Specialists. Works on projects/matters of limited complexity. Gains experience of the procurement process, commercial and contract management. Builds relationships with stakeholders involved in procurement activities. Supports local purchases within limited scope. Key focus area tactical purchasing. - Grade Specific Role OverviewFollows the sourcing strategyOrganizes the process of Request for Proposal RFP as per guidelinesHelps identifying potential providersHas basic knowledge of the Stakeholder community within the work perimeterManages relationships with tactic providersParticipates in analyzing supplier performancesMaintains contact with clients suppliers on specific contract procurement matters Supports delivery of Procurement services into the BusinessUnderstands the P2P process and supplier costs across business Has basic knowledge about cross functional workBuilds knowledge experience in a number of domains of expertiseGeneral Responsibilities AccountabilitiesProvides services according to the scope assigned by the Category to meet specific KPIsSupports Sourcing Specialists in driving small spend RFxExecutes sourcing strategies to obtain quotations to meet internal Stakeholders requirements Ensures correlation between contract, quotes and Purchase Requisition during the validation processResponsive to local Stakeholders in solving dayto day sourcing activitiesCooperates with senior professionals on requests coming from StakeholdersAccountable for process compliance within the work perimeterContributes to global strategy complianceContributes with local input to global categories strategiesContributes to Category sourcing strategy including forecasting, identification, delivery and reporting of savingsContributes to the supplier maintenance process Acts to overall procurement policies and processes Skills (competencies)

Skill required: Marketing Operations - Quality Management Designation: Quality Auditing Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help balance increased marketing complexity and diminishing marketing resources. Drive marketing performance with deep functional and technical expertise, while accelerating time-to-market and operating efficiencies at scale through Data and Technology, Next Generation Content Services, Digital Marketing Services & Customer Engagement and Media Growth Services.Role requires Digital Marketing Ads & Promotion creation/designAct of overseeing all activities and tasks needed to maintain a desired level of excellence. This may include the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. What are we looking for Quality AnalysisQuality AuditingService Quality ManagementHTML5Hyper Text Markup Language (HTML)Ability to perform under pressureProblem-solving skillsResults orientationCommitment to qualityWritten and verbal communication Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation