493 Capa Jobs - Page 8

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 DefinitionWork as a quality manager and lead the quality team for diesel engine and genset assembly & test function. Performs advanced inspection and audits to track, analyze, and report on materials, processes, and products to ensure conformance to company's quality standards.ResponsibilitiesManage the Dily quality issues on the engine assembly line. Guild team to analyse the issues and provide the RCCA. Maintain the best practices and discipline on the line and make sure the quality of the product is as per standard. Conducting measurement systems analysis; gathering, analyzing, and communicating non-conformance data. Analysing non-conformance data and maintaining quality system documentation. Should use the statistical analysis tools to analysis the problem. Participating in and offering technical support to internal and external ISO 9001 audits; following up response of corrective action from audit. Interacting with manufacturing other cross functional team members to determine root cause of quality issues and ensure that corrective and preventive action is implemented.Degree RequirementDegree or equivalent experience desiredSkill 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 Working KnowledgeUtilizes quality indicators relevant to own unit or function. Adheres to organizational quality management processes and practices. Applies key aspects of continuous improvement processes and evaluates impact on quality. Uses quality evaluation tools and techniques such as walkthroughs and inspections. Works with quality assurance methods, tools and techniques.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 Working KnowledgeContributes to the development and implementation of specific manufacturing procedures. Investigates the need to refer potential exceptions upward for review and approval. Explains the rationale for procedures and standards in own area of responsibility. Participates in the implementation of manufacturing standards and procedures to one's own function. Provides feedback for improvement of procedures.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. Posting Dates: June 16, 2025 - June 24, 2025 Caterpillar is an Equal Opportunity Employer. Not ready to applyJoin our Talent Community.

This role involves the development and application of engineering practice and knowledge in defining, configuring and deploying industrial digital technologies (including but not limited to PLM and MES) for managing continuity of information across the engineering enterprise, including design, industrialization, manufacturing and supply chain, and for managing the manufacturing data. - Grade Specific Focus on Digital Continuity and Manufacturing. Develops competency in own area of expertise. Shares expertise and provides guidance and support to others. Interprets clients needs. Completes own role independently or with minimum supervision. Identifies problems and relevant issues in straight forward situations and generates solutions. Contributes in teamwork and interacts with customers.

Role & responsibilities : Responsible for following activities: Handling of Change controls, Deviations, Market complaints, CAPA and other QMS Documents. Participate in investigation of Nonconformities. Participate in quality risk management and maintain its record. Preparation and review of Product Quality Review Report (APQR). To execute product recall and mock recall activities. To coordinate for management quality review meeting. Handling of internal audit activities and compliance with CAPA. Preparation and review of SOPs, SMF, Quality Manual Preferred candidate profile ERP/ QMS software system handling experience

Supplier Quality, Rubber Industry APQP, POKA-YOKE, Audits, MIS, Customer handle, English strong, Quality reports, ppe's, fpa, quality control, vendor quality, sqa,

Act as SME for review Quality Incidents, Change Controls, CAPA;s and procedures for IT systems. Responsible for review/Approval of stand Alone/Enterprise GxP Computerized systems validation documents, including enhancements. Responsible for review/approval of IT infrastructure qualification documents, including enhancements. Author & review CS-VMP and associated protocols & report templates. Conduct trainings in the areas of (CSV SOPs and related topics) to develop in-house capability. Support audit/assessment of suppliers of GxP IT Computerized Systems as SME. Support Audit preparation and remediation activities, as appropriate. Responsible for Monthly Reporting, as applicable. Support IT Compliance/Data Management/Data Security & Data Integrity for GxP computerized systems. Conduct Self Inspections for IT Compliance, establish CAPA to correct deficiencies and ensure closeout. Coordinate with the cross functional team to ensure timely initiation and closure of all QMS activities Viz., Incident, CC, CAPAs, as applicable. Report and escalate issues, as situation demands. Perform other duties, as assigned.

Role & responsibilities Inspection - release/rejection of incoming material against approved specification. Rejection of material non conformance review, reporting in IMSxpress. Updation of critical incoming material list (incoming material specification) based. Allocation of catalogue number to finished products depending on customization/changes in product. Control of documents (QSP, SOP, formats, MFR, MQR) issuance, retrival, archival and updation in IMSxpress. Compiling of data for MIS as per schedule Allocation of batches as per customer purchase order over mail. Review of certificate of analysis for finished products. Daily IPQA of production and BMF as per the approved protocols and procedures and subsequent reporting. Issuance and handling of change control, non conformity, CAPA in IMSxpress Issuance and handling of Deviations Issuance and maintenance of BMR Handling, Recording and compilation of customer complaints Updation and maintenance of departmental risk register. Participating in product Validation. Review of packing order, checking of labels and Shipments to customers. Participating in Internal/external audit as per audit agenda and responsibility allotted. Preferred candidate profile Should have a Bachelors or Master's degree in pharmacy/biotechnology/Biochemistry or other relevant scientific discipline with 2/3 years experience in Quality Assurance. Knowledge of GMP standards, SOPs and quality management systems • Awareness of QMS as per ISO13485: 2016 and ISO 9001:2015 standards • Data collection and management • Customer service orientation • Excellent relationship management skills with the ability to engage, negotiate and manage key stakeholders and suppliers • Strong and confident negotiator with the ability to negotiate at all levels • Excellent communication, interpersonal and influencing skills • Results orientated with ability to plan and deliver against deadlines • Ability to add value, reduce costs and make improvements • Computer literate, especially Excel skills

EXECUTIVE-SALES PPC/-/1306251 Marketing Coimbatore Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 2 years ShareApply Basic Section No. Of Openings 1 Designation Grade Executive M10 Freshers/Experience Experience Employee Bonus Two Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Chemical India Private Limited Department Marketing Country India State Tamil Nadu Region Coimbatore Branch Coimbatore Skills Skill Market and Competitive Analysis Minimum Qualification Any Graduate BSc MBA CERTIFICATION No data available Working Language Tamil English About The Role Candidate taken for the replacement of Mr.N.Sabariyar who is looking in market cirlce-COI02 of Cbe branch.Candiate should be minimum 2-Years experience in marketing and having good knowledge in system.

Trainee - chemist PPC/T-C/1299164 Warehouse - Quality Madhavaram Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 1 - 1 years ShareApply Basic Section No. Of Openings 2 Designation Grade Executive M10 Freshers/Experience Freshers Employee Bonus Two Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Chemical India Private Limited Department Warehouse - Quality Country India State Tamil Nadu Region Madhavaram Branch Madhavaram Skills Skill Quality Assurance Minimum Qualification BSc CERTIFICATION No data available Working Language English Hindi About The Role To Sample and testing the incoming Raw material, finished goods & Packing material. To inspect in process batch and to test for batch release. To inspect product vessels and provide clearance for production. To develop testing SOP and test methods. To coordinate during external and internal audi ti ng.

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : Computer System Validation (CSV ), Veeva Vault , Trackwise , Argus The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement. Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements. Skills and attributes for success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills. Interested Candidates can send their cv's to frichardson@allegisglobalsolutions.com Looking for candidates from Pharma Companies. Regards, Franklin.A

Engr, Asst Mgr Q.A-in-house quality standards, QAD goals / target, Ensure periodic reporting Q.A Performance, CMM, CAPA, PPAP,FMEA, ISO 9001/14001/45001,5S, Customer complaints handling & effective problem-solving and global 8D, failure analysis

Job Objective: Plan, allocate and review testing for the release of all RM, processed material, finished products to achieve the committed lead time for Production and for achieving targeted OTDIF Maintain microbiological laboratory GLP compliant as per Schedule L of Drug and cosmetic act. Ensure implementation and sustain of safe environment in microbiology laboratory. SOP review & availability of current version Roles and Responsibilities: Daily review of testing of FP, RM, Water, Air, In-process & Swab as per given procedure and frequency. Daily work allocation to microbiologists. Daily review of records and logbooks maintained in microbiology laboratory. Daily communication to operation and QA for any OOS or OOT related to microbiology testing. Investigation and root cause analysis in case of microbiological failure (OOS/OOT) and implementation and sustenance of CAPA CAPA checklist audit as per define checklist and presenting data to higher management during global micro meeting. Review of microbiological trends for air and water as per define procedure and frequency. Surveillance of shop floor for GMP adherence. SAP entry for finished product in absence of microbiologists Maintaining microbiological laboratory as per laid down procedure. Review of Q & V documents related to microbiological risk involved. Review of validation activities in microbiology laboratory. Composite sample preparation and insurance in absence of microbiologist. Microbiology awareness training to shop floor people. Laundry audit / Monitoring of Housekeeping activities & Self inspection of various departments GLP and documentation, laboratory facility maintenance Microbiological testing of FP, RM, Water & Air in absence of other microbiologists

Leading BPO in Chennai Hiring for Quality Manager Domestic Banking Process Must be a Manager Quality or tenured Deputy Manager On papers in a BPO in Domestic Banking process Over All Experience 8+ Years CTC UPTO 13LPA based on Last CTC & experience 6 Days Working LOCAL CANDIDATES PREFERED Interested candidates can mail their cv at simmi@hiresquad.in or call at 8467054123 Role & responsibilities Act as a primary POC between the QA teams, OPS & clients. • Recommended responsibilities include but are not limited to the following: • Lead, manage, motivate, and mentor a team of Quality Analysts • Drive consistency to ensure the strong quality performance and alignment across all programs • Deliver process as well as agent level insights to continuously improve and deliver outstanding customer experience across the program • Work alongside Ops and hiring team to provide on-boarding, coaching, remediation, training and development for QAs and QA Leads • Implement and drive the QA process and structure • Identify possible issues and trends and give actionable insights while communicating them to relevant stakeholders • Implement initiatives and projects to counteract any possible trends, drive business KPIs • Aggregate audit findings and analyses gaps in processes, identifying innovative ways to solve problems upstream, help improve customer experience and drive higher efficiency • Analyses quality and performance trends to provide recommendations for program improvement • Responsible for the delivery of vendor quality metrics at management reviews Key skills & knowledge: Excellent communication & interpersonal skills Excellent MS Office skills (presentation & excel) Should have good knowledge of FMEA identification and mitigation of vulnerabilities Excellent knowledge of Quality & Analytical tools Should be well versed with Qualitative concepts Should have worked on process improvement projects driving Customer Experience, Process Improvements & Profitability Interested candidates can mail their cv at simmi@hiresquad.in or call at 8467054123

Naksha solutions is looking for Documentation and QC Manager to join our dynamic team and embark on a rewarding career journey A QC Manager is responsible for managing the quality control process within a company or organization They oversee the quality assurance procedures for products, services, and processes to ensure they meet the required standards and specifications The QC Manager must be skilled in analyzing data, identifying trends, and implementing corrective actions to improve quality control Develop, implement, and maintain quality control policies and procedures Establish quality control metrics and benchmarks to monitor product and service quality Develop and oversee quality control inspection and testing procedures Analyze quality control data and trends to identify areas for improvement Develop and implement corrective actions to improve quality control processes Ensure compliance with industry standards and regulatory requirements

Extrusion knowledge, Shrinkage factor, Oversee and monitor the extrusion process to ensure products meet quality standards and specifications, Troubleshoot and resolve any operational issues related to extrusion equipment or processes, TPM, 7QC tools

Role & responsibilities Responsible For Assisting Audit, Quality Manager and MR In Implementing Goals, Objectives,, Policies, Procedures and Systems Pertaining to the Quality Control and Regulatory Functions Responsible For Assisting Audit, Quality Manager and MR for Documentation Related to Quality System Guidelines Assisting In Implementing & Documenting for Iso Processes

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Officer Parenteral Job Requisitions No : 13861 Job Description Purpose of Job To supervise all activities in oncology parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities, Skill Required To supervise all activities in oncology parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities, Roles and Responsibilites To ensure cGMP compliance in the department, To ensure area, equipment and line clearance and cleaning of equipment before startup of the operation, To ensure that after completion of operation line closure activity should be performed in accordance with SOPs, To ensure that deviation, change control, CAPA is generated as and when required, To maintain the area cleanliness and arrangement before and after completion of activities, To provide technical support relating to equipment utilized in the area by repairing, maintaining and modifying production equipment utilizing technical expertise, technical manuals, precision tools and test equipment, To provide the versatility training and development of the team members, To prepare the SOPs related to area and contribute to revision of SOPs, To prepare MPCR and to ensure the production operations are followed as per the MPCR, Responsible for completion of all documentation in a timely manner and to ensure that all the Equipment log, records of housekeeping,formats and MPCRs are online, Execution of qualification activities as per qualification protocol, To ensure that production is going as per predefined schedule, To co ordinate with engineering department for normal functioning of the machine in the departments Also adhere to the preventive maintenance and calibration schedules, Any other job assigned by the superiors, In absence of said employee his/her job responsibility shall be taken care by another employee working along / under /above him/her and shall be mention in job responsibility, To ensure the compliance of EHS norms in Parenteral area, To follow ?Good Documentation Practices and Data Integrityrequirements during any GxP Operation and recording at site, To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed, To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP Data (Records, Reports) Specific To Job Description, To ensure that, In case of any event of potential data breach, it shall be handled through SOP on ?Handling of Potential Data Integrity Observation, To supervise all activities in oncology parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities, Qualification Required Pharmacy with reputed co Relevant Skills / Industry Experience Should have 4 5 years of experience in sterile mfg, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

To ensure that process is carried out as per system and customer requirements. Handling customer complaints and monitor organization has met customer requirements. Responsible for yield at various stages of production processes. Authorized to stop the process in case of non conformity and work with production and process development for solutions. To ensure that identification and traceability are maintained as per requirements. Track issues, get corrective actions and ensure the closure. Raise internal NC report and ensure the closure and effectiveness. Actively participate on ECP meetings, APQP meetings and Customer complaint meetings and ensure it is effectively implemented in line. Organize Operational meetings and Quality review meetings (for yield improvements) and track actions for closure. To learn current updates and developments in the field. To perform continual improvement projects and give suggestions for improvements. Quality point of contact for any customer concerns. Recording customer complaints and acknowledge the customer with containment actions. Analysis with cross-functional team with the help of quality tools Plan corrective and preventive action against customer complaints together with the related departments. To effectively follow-up the action items related to customer complaints and ensure effective closure. To review and initiate for any process / engineering / document changes wherever necessary. Update 8D report and send to customer. To monitor and audit the effectiveness of the corrective and preventive actions. To review the RMA request from customers, Allocate RMA number and communicate to customers. To arrange / attend RMA meetings, analyze RMA rejections, plan corrective actions and to keep data, track and close the loop. To visit customers as and when required for warranty rejection analysis as well as customer complaints.

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

Role & responsibilities Lead the vendor qualification process, including the evaluation and approval of new and existing vendors. Review and approve vendor documentation to ensure compliance with internal standards and regulatory requirements. Manage QMS notifications, ensuring timely resolution of issues related to change control, deviations, and CAPA. Oversee the preparation, review, and approval of SOPs to ensure alignment with current practices and regulatory standards. Conduct comprehensive risk assessments and risk analysis to identify potential quality issues and implement mitigation strategies. Independently plan, conduct, and report on vendor audits, coordinating with internal and external stakeholders to schedule and execute audits. Preferred candidate profile Bachelors or Masters degree in Pharmacy from a reputed institution. Should have 10 -15 years in corporate quality assurance roles within the pharmaceutical, biotechnology, or related industries. Should be proficient in quality management software such as Trackwise, Caliber, SAP, TMS, DMS, and QAMS. Should have experience in vendor qualification management, vendor documentation and managing vendor audits.

Experience in Document control, formatting, handling softwares, MS Word, Excel and PPT, SOPs, WIs, policies, maintaining trackers, good communication skills, coordination with other departments and vendors. System and Project audits. Required Candidate profile Good Communication;2-4 years of experience in QA;5-8 years of experience in Clinical Research/ Pharma / CRO,

Position- Bankruptcy QC Associate POSITION SUMMARY-The BK QC Associate plays a critical role in reviewing and ensuring quality standards, processing accuracy and compliance as per predefined checklist. This position requires an understanding of legal documentation, including but not limited to court orders, retainer agreement, affidavits, and BK filings, which are essential for to deliver its services. The BK QC Associate will collaborate closely with the BK Coordinators from both US and IND businesses to execute daily responsibilities. Shift Timing- 2 PM to 9 PM / 3 PM to 12 midnight / 6 pm to 3 am / 9 pm to 6 am JOB RESPONSIBILITIES- Collaborate with onshore and offshore teams to ensure quality compliances and processing accuracy for daily operations. Independently audit population/sample proportion of the processed tickets basis the predefined checklist for the tickets assigned via email, Salesforce, Jit Bit, RAGIC, ARCHER Connect and other data sources, at a set frequency as defined by the business. Ensure random audits, at least twice or thrice per month, to check documentation around the BK Claimants. Perform random sample checks on the communication sent/received to/from Trustees. Accurately review and interpret legal especially court motions/orders, affidavits, PACER reports, and legal heirship documents. Build up a quick learning curve to ensure an in-depth understanding of the Standard Operating Procedures (SOPs) and training materials. Setup weekly connect with business for TNI in collaboration with trainers for SOP updates & PKT requirements. Create weekly/monthly reports for the audits performed on the set frequency and report out to supervisor and business with requisite analytics & inferences. The report should be inclusive of root cause and CAPA (Corrective Action/Preventive Action) for the defects/deficiencies identified during quality audits. Technical Skills: Advanced proficiency in MS Office, including Excel & PowerPoint, MS Teams and Outlook. Experience in quality audits of legal documents/ email communications. Should have the ability to comprehend legal terminologies and scope of work required during quality audits. To have understanding and maintain checklist of requisite state/district wise requirements if any Strong data analysis capabilities, with an eye for detail to identify errors. Exceptional written and verbal communication skills, with the ability to derive insights from information provided. Analytical problem-solving skills for addressing complex issues. Basic understanding of tools and techniques such as CAPA, RCA, FMEA, SPC & 7 QC tools.

Conduct audit and coordinate non-conformances activities related to Supplier Quality Assurance (SQA) & new component development implement Corrective & Preventive actions at supplier end ensure all components /products procured and processed Required Candidate profile Exp in Supplier Quality Assurance & Electrical Equipment Manufactuering PPAP Exp Monitor and take necessary CAPA on the rejections of supplier at incoming inspection Maintain the data in tracker Audit

JD: Mandatory Skills - ITIL, CSV, Process Management, Change Management, Pharma, audit, Compliance & Any certificate ITIL V3 / ITIL V4, CAPA, RCA Global Quality IT Manager Act as SME for review Quality Incidents, Change Controls, CAPA;s and procedures for IT systems. Responsible for review/Approval of stand Alone/Enterprise GxP Computerized systems validation documents, including enhancements. Responsible for review/approval of IT infrastructure qualification documents, including enhancements. Author & review CS-VMP and associated protocols & report templates. Conduct trainings in the areas of (CSV SOPs and related topics) to develop in-house capability. Support audit/assessment of suppliers of GxP IT Computerized Systems as SME. Support Audit preparation and remediation activities, as appropriate. Responsible for Monthly Reporting, as applicable. Support IT Compliance/Data Management/Data Security & Data Integrity for GxP computerized systems. Conduct Self Inspections for IT Compliance, establish CAPA to correct deficiencies and ensure closeout. Coordinate with the cross functional team to ensure timely initiation and closure of all QMS activities Viz., Incident, CC, CAPAs, as applicable. Report and escalate issues, as situation demands. Perform other duties, as assigned.

Implement & manage QMS as per ISO/IATF standards. Lead audits, CAPA, document control, process compliance, quality improvement, customer complaints, root cause analysis, and ensure adherence to regulatory & customer requirements.

Role & responsibilities: Inspection schedule as per client call. Inspection of products as per AQL 1.0 & IS 2500-2000. Inspection check sheet & Tech specs will be provided by client. Checking the products as per drawing (Aesthetics & Dimensional) Making separate reports for different supplier. Bi-Annually audit of respected supplierss Taking CAPA reports of rejections found during inspections from supplierss Making good behaviour between suppliers & clients. Process knowledge like plating, lacquering & powder coating. Auditing exposure like vendor audit, 5s audit, product audit, process audit. Knowledge about quality control plan. Awareness about raw material standards. Knowledge about 8D, CAPA report. 7QC tools. Quality, QA & QC knowledge. Calibration activity and its documentation. Instruments knowledge & their LC. Interested candidates please share CV on sayeeda.pathan@sgs.com