493 Capa Jobs - Page 13

SUMMARY Ensure the quality of incoming materials, in-process production, and finished products meets defined standards. Manage PPAP activities for new parts, engineering changes, and improvement projects to ensure compliance with design and industry requirements. Investigate root causes of internal defects, customer complaints, and rework using quality tools, and implement effective corrective and preventive actions (CAPA). Conduct regular internal and supplier audits to ensure compliance and drive quality improvements. Support continuous improvement initiatives to reduce defects and increase operational efficiency. Ensure all quality activities align with the requirements of the Integrated Management System (IMS). Requirements Qualification: B.E. in Mechanical Engineering Experience: 12 years of experience in the manufacturing industry Skills Required: Proficiency in relevant software and tools used in quality management, data analysis, and documentation In-depth knowledge in SAP QM module Knowledge in Microsoft Excel and PowerPoint are preferred

JD: 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per seniors guidance. 5) To be prepare cleaning validation protocol and report as per seniors guidance. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 17) To be controlled all master documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products. 20) Preparation of documents for Certification & product registrations work i.e. FDA, Halal, Kosher, Reach. etc. Review specification, test procedure and SOP's for their deficiencies according to audit points 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per senior’s guidance. 5) To be prepare cleaning validation protocol and report as per senior’s guidance. 6) To be conduct training and evaluation done as per Schedule. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 13) To be prepared data for monthly report as per QMS and submit to senior. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products.

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD – Manufacturing / QMS (Senior Officer / Officer / Executive) Experience - 02 to 07 Years Qualification – B. Pharmacy/ M Pharmacy Engineering (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification – BE / B Tech Time and Venue : 14th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

Maintain QMS & ensure compliance with GMP standards across the plant Conduct audits, compile reports, approve vendors for RM & packaging Review documentation like SOP, BMR, BPR, APQR, etc Handle deviations, complaints, OOS reviews, and implement CAPA Required Candidate profile Experience facing audits in the pharma intermediates/API/bulk drug industry only; formulation experience not relevant Excellent communication skills for audits. Fluency in English & MS Office.

Greetings from Infosys BPM Ltd., We are looking to hire a Quality Analyst at Mangaluru, Karnataka, please find the below job description for your reference and apply if interested. Job Role: Quality Analyst Work Location: Mangaluru (work from office) Education Qualification: Full-time graduation / Post graduation Experience required: At least 4 years of experience in Quality Assurance and Process Improvements Job Description: Good experience & knowledge in Quality management Systems, Process Improvement, Service Delivery Quality Management Systems. Good working knowledge of Quality Control and Quality Assurance methodologies Good working knowledge of Root Cause Analysis (RCA), Failure Mode Effects Analysis (FMEA), Lean methodologies Experience on Quality Assurance practices leading Stable and predictable process performance Experience in leveraging industry leading Quality audit platforms Ability to analyze complex data and share key process. Lean and Six Sigma concepts understanding Good communication skills Regards, Infosys BPM Talent Acquisition Team

Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

Candidates with IKEA supplier experience are preferred Ensure compliance with relevant chemical & regulatory standards Coordinate testing with third-party labs maintain compliance status & documentation Support customer & certification audits Required Candidate profile Collaborate with R&D, Procurement, and Production teams Address compliance risks through CAPA processes Stay updated on regulatory changes Knowledge of PDOC, GONOGO, and IKEA Connect preferred

Roles and Responsibilities Conduct quality audits, inspections, and reviews to ensure compliance with industry standards and company policies. Identify areas for improvement through root cause analysis (RCA) and implement corrective actions using tools like Poka Yoke, Capa, and Kaizen. Develop and maintain documentation related to quality control processes, including procedures, checklists, and reports. Collaborate with cross-functional teams to resolve issues related to product defects or non-conformities. Desired Candidate Profile 3-8 years of experience in a manufacturing environment with expertise in 7QC, 5S, IPQA/IPQC, IATF 16949:2016 certification. Strong understanding of QC tools such as Vernier caliper, Micrometer, Height gauge; rejection analysis; reject handling process. Proficiency in MS Office applications for document preparation and record-keeping. Regards Aadhya Agrawal 8439753001

Requirements: Should have managed tests/ examination like Microstructure Examination, Failure investigation, Heat treatment, FMEA, IATF Core Tools Knowledge, NDT Testing. Candidate should be of metallurgy profile from Automobile/Auto Component or Steel Industry. Job Description: Preparation of Technical delivery conditions for different grades of material. Study MFR from supplier and confirmation on MFR. Supplier communication for Non-conformance, CAPA follow-up. Supplier selection based on quality, section and grade for RM ordering. Supplier Audit and ratings. Study all furnaces behaviour with travelling thermocouple readings, SCADA report Study. Monitoring of hardening cycles and furnace behaviour through hardness readings and Metallurgical inspection, revision in HT cycles. Understanding of characteristic of quenching oil cooling curve. Provide HT cycles for new product development. Online Failure study and root cause analysis. Verification of the reports of microstructure examination of raw material for chemistry, inclusion rating, grain size, microstructure, decarb in RM inward stage and process. Technical discussion with management for any issue or customer complaint. Handling of customer audits. Communication with technical consultant in case of any issue. Study customer standard and confirm the feasibility of mechanical and metallurgical requirements. Study heating parameters of parabolic and HT furnace to achieve desired properties. Provide technical know how to handle new grade starting from RM to Shot peening Detailed failure investigation of new product developed failed parts with proper presentations. Communication with marketing and customer regarding customer complaint Failure investigation and provide failure report (CAPA). Implement and monitoring action taken after CC. To do research in any problem related to metallurgy and provide technical knowhow. Monitoring QA Lab functions. Understanding of working function of Metallurgical microscope, Spectrometer, Vickers hardness testing and XRD. Preparation of checklist, SOP and WI for all lab equipment's. QMS check list for Lab (AMC, calibration plan, Breakdown history etc.). CO - ordination with 3rd party for inspection and testing queries. Participation in thermocouple validation for furnace. Increasing in-house testing facility to reduce dependency on external testing agency. Perform regular check on heat treatment process sheet and ensure for no deviation Monitoring Routine calibration of Laboratory equipment's Participate and accountable for quench media testing and its specific control Work on ISO/IAFT/ QMS activities Practice safe working techniques and adhere to environmental, health and safety (EHS) policies, guidelines, and procedures CQI-9 to be maintained and implemented for Heat Treatment. Any specific skills/competencies required : MS Office, Advanced Excel, Power Point.

Managing and implementing QMS with deep expertise in ISO 9001, ISO 14001, ISO 45001, and IATF 16949. Experience in Automotive manufacturing is a must. Drive continuous improvement initiatives, focusing on reducing waste & improving efficiency. Required Candidate profile Implement (CAPA) based on audits, customer feedback, and internal analysis. Exp of Export related compliances like Sedex, BSCI etc, with excellent communication skills. Must have dealt with customers

FQP Engineer Qualification : B.tech/Diploma- Civil Job Responsibility: • Overall responsible for quality work of entire project • preparing Monthly Quality Report • Ensuring the QA of foundation works, Regular site inspection and issued NCR if non-compliance of the activity as per given FQP • Prepared Root cause analysis, CAPA and issued closure report of NCR. • Taking care of QA/QC documents of the entire project including certificates, calibration, test results, inspection requests, non-compliance reports and site instruction/observations and other QA/QC documents. • Develop and determine all standards to perform inspection and tests on all procedures and oversee all testing methods and maintain high standards of quality for all processes. • Worked as a QA/QC Engineer for construction of the transmission line • Review quality of all materials at the site and ensure compliance with all project specifications and quality and collaborate with the department for all material procurement and maintain a quality of materials. Overall responsible for quality work of entire project, preparing Monthly Quality Report Prepared Root cause analysis, CAPA and issued closure report of NCR.

Greetings for day. We are having opening for the role Manager - QMS & Documentation Management in Corporate Quality Department. Department : Corporate Quality Location : Mumbai - Andheri East Qualification - B. Pharm. / M. Pharm / M. Sc. Industry Preferred : Pharmaceutical. Work Experience :12 - 18 years Corporate Experience only. Job Description : Quality Management System (QMS) Oversight: Ensure robust implementation and periodic / Retrospective review of all QMS elements including Change Control, Deviation, CAPA, Risk Management, and Quality Review. Documentation Lifecycle Management: Coordinate periodic SOP revision cycles. Ensure alignment with current practices, regulations, and audit feedback. Maintain SOP revision matrix and history. Electronic QMS/LMS Integration & Control: Develop and deliver orientation programs for new joiners covering company policies, ethics, compliance, and site-specific SOPs. Skill Requirements : Competent in extracting, organizing, and interpreting data from QMS systems for management review and trend analysis. Experience in preparing Quality Metrics, Dashboard Reports, SOP compliance trends, and identifying areas for process improvement Proficient in managing the document lifecycle, Organized approach to multi-department coordination, documentation deadlines, and QMS project execution. GMP Knowledge & Facilitation Skills: Deep understanding of cGMP/GxP concepts and strong delivery of technical training sessions . Interested candidate can share their profiles on pooja.t@encubeethicals.com

Were Hiring! Walk-In Drive Alert! Location: ARCHER Transnational Systems Pvt Ltd, Ground Floor, South-West Part, Alembic Business Park, Gorwa, Vadodara, Gujarat 390003. Date: 14 June 2025 Time: 9 am to 3 pm 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 ARCHER 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. 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. KNOWLEDGE AND SKILLS: Bachelors degree in any field (preferably in Law/ BBA or commerce). 2 - 4 Years of experience in a US-based multinational corporation. Project management experience or certifications are highly desirable. ISO 9001 onwards any such certification is preferrable 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. Behavioral Skills: Strong problem-solving skills, with a solution-oriented mindset. Ability to handle confidential information with discretion. Strong interpersonal and customer service skills. Keen attention to detail, anticipating potential challenges and addressing them proactively PREFFERED KNOWLEDGE: Familiarity with US legal laws or bankruptcy processes is an advantage. Experience in operations or business analysis You can share your resume on careers.india@archersystems.com / You can send your updated CV via email to lfernandes@archersystems.com

1.0 Job Responsibilities 1.1 Preparation and review of SOPs. 1.2 Handling of QMS documents- Change controls, Deviations, Incidents, OOT, CAPA and OOS. 1.3 Handling of Market Complaints, Return goods & Product recalls. 1.4 Review of RM, PM, IP and FP specifications and STPs. 1.5 Preparation and review of Calibration Certificates, COAs. 1.6 Review of Analytical Raw data. 1.7 Review of analytical method validations. 1.8 Responsible for Vendor management- Review of Vendor development documents and approval process. 1.9 Handling of regulatory inspections. 1.10 Audit compliance.

BAPS SWAMINARAYAN HERBAL CARE is looking for QC/QA Executive to join our dynamic team and embark on a rewarding career journey You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)

Quality Management System (QMS) Implementation:- Develop and oversee the laboratory's Quality Management System (QMS) in compliance with standards such as ISO 15189, (Medical Laboratories Requirements for Quality and Competence) and IS0 17025 (standard for testing and calibration laboratories) Establish and update Standard Operating Procedures (SOPs) for all laboratory processes. Conduct regular internal audits to ensure adherence to quality standards. Quality Control (QC) and Assurance (QA):- Implement Internal Quality Control (IQC) and participate in External Quality Assurance (EQA)/Proficiency Testing (PT) programs to ensure test accuracy and reliability. Analyze QC data, identify trends, and take corrective actions if results deviate from acceptable ranges. Monitor and review the turnaround time (TAT) for test results to ensure timely reporting. Molecular Genomic Research, Institutional Services Diagnostics Ph. D/M.Sc. in life science (Biotechnology/Medical Microbiology/Microbiology/ Medical Biochemistry) with certification ISO 15189:2022 (Medical Laboratories Requirements for Quality and Competence) IS0 17025 (standard for testing and calibration laboratories) Minimum of 2/3 years work experience in Quality Management System (QMS) Implementation Regulatory Compliance:- Ensure compliance with national and international standards such as ISO 15189, IS0 17025 CAP (College of American Pathologists), NABL (National Accreditation Board for Testing and Calibration Laboratories), or local health regulations. Prepare the laboratory for accreditation assessments and audits. Maintain proper documentation and records for audits and inspections. Training and Competency Assessment:- Organize training programs for laboratory staff on quality standards, safety protocols, and SOPs. Conduct regular competency assessments of lab technicians and provide feedback. Promote a culture of quality and continuous improvement within the laboratory team. Handling Non-conformances and Risk Management:- Investigate non-conformities, errors, and customer complaints, identifying root causes and implementing corrective and preventive actions (CAPA). Maintain a system for reporting incidents such as sample mix-ups, equipment malfunctions, or test inaccuracies. Develop risk management strategies to prevent potential quality issues. Process Improvement and Data Management:- Use Quality Indicators (QIs) to monitor lab performance (e.g., TAT, error rates, sample rejection rates). Analyze trends and suggest continuous improvement initiatives (Lean, Six Sigma) to reduce errors and inefficiencies. Implement Laboratory Information Management Systems (LIMS) for proper record-keeping and tracking. Equipment Maintenance and Calibration:- Ensure that all laboratory equipment is calibrated, maintained, and validated according to standards. Maintain records of equipment performance and service history. Coordinate with vendors for proficiency testing materials and quality reagents. Customer Satisfaction and Feedback Management:- Collect and analyze feedback from patients, doctors, and other stakeholders. Address concerns and complaints promptly. Work with the lab team to improve service quality based on feedback.

Senior Executive Quality - Private Label FMCG (Non-Food: Home Care, Personal Care, Baby Care Products) Location: Bangalore Job Summary: Quality Private Label FMCG (Non-Food) will be responsible for ensuring the highest quality standards in the development, production, and delivery of Home Care, Personal Care, and Baby Care products. The role involves collaborating with cross-functional teams, managing supplier quality, and adhering to regulatory compliance to ensure customer satisfaction and brand reputation. Key Responsibilities: Define and implement quality standards, specifications, and guidelines for Home Care, Personal Care, and Baby Care product categories. Work closely with 3P Suppliers for R&D and product development to ensure products meet safety, performance, and quality benchmarks. Conduct product evaluations, sensory testing, and performance assessments during development phases. Ensure the products comply with regulatory standards- BIS,FDA,ISO, Ayush Conduct comprehensive audits of Home Care, Personal Care, and Baby Care product Suppliers to ensure compliance with quality standards and regulatory requirements. Ensure on boarding of New FMCG suppliers with adherence to quality and regulatory criteria. Analyze quality trends and implement continuous improvement initiatives across manufacturing and supply chain processes. Identify root causes for quality issues and drive corrective and preventive actions. Provide training and support to new suppliers to help them understand and comply with company standards. Responsible for handling end-to-end quality operations in the retail supply chain. Travel to multiple 3rd party supplier locations within the city and out of the city for Quality inspections and solving the issues. Framing of Specifications and SOPs for Home Care, Personal Care, and Baby Care Products Should have good command on leading the FMCG Nonfoods Project from development to Implementation. Strong Technical Knowledge on Drug &Cosmetic, Ayush license, LM , PCB & Labeling Guidelines. Develops and implements Nonfood regulatory and quality strategic plan for Private label brands in concert with corporate strategic plan. Address and resolve customer complaints related to product quality in a timely and effective manner. Use customer feedback to drive product and process improvements. Develop supplier QA team continuously through training, knowledge sharing and follow up. Working and interacting daily with the 3 rd Party Suppliers and corporate QA Team on projects related to Quality and safety efficiencies. Guidance needs to be provided from time to time for the Supplier Quality Team. Key Skills: Ability to develop & lead the project Individually. Should have strong experience in managing stakeholders and understanding of the strategic sourcing process. Able to utilize and critically evaluate data from a variety of sources to identify root cause and lead teams towards resolution. Proven experience in NonFood Categories like Home care, Cosmetics, paper & disposables, party needs, puja articles, general merchandise etc. Process oriented with excellent communication and problem-solving skills. Strong communication skills verbal and written, ability to communicate effectively to varied audiences Self-motivated, able to perform role with minimal supervision Able to manage multiple priorities in a dynamic environment Ability to work in a team environment to consistently achieve results & achievement. Strong organizational skills Demonstrates a positive can-do excellent teamwork attitude with strong communication/ information sharing skills A self-starter capable of designing and implementing services/processes Team player who can collaborate across multiple functional areas Qualifications: Bachelors/Masters degree in Chemistry, Cosmetology Chemical Engineering Minimum 5 years in quality assurance/quality control, preferably in FMCG (Non-Food) Home Care, Personal Care, or Baby Care products. Familiarity with chemical formulations, product testing, and regulatory frameworks. Proficiency in quality management tools and techniques (e.g., FMEA, SPC, CAPA). Should have Good Knowledge on Data analysis & Excel, Word, PPT. How to Apply Interested Candidates please share your resumes at - sandhya.tiwari1_ch@external.swiggy.in

Overview Conducting quality checks of RM/PM material received in the plant to ensure that all FLI standards of quality are met. Monitoring RM/PM tests, reporting of non-compliance of service providers and communication about the corrective action. Maintaining accurate and comprehensive reports for communication to all the people concerned. Conducting regular audits of RM/PM stores for storage condition and FIFO/FEFO implementation. Ensure the smooth implementation of food safety policies at plant. 2) Ensuring best quality of RM/PM received in through quality checks and inspection. 3) Implementing right quality control systems/standards for the vendors / suppliers. 4) Responsible for ensuring the maintenance of implementation of GMP, GHK GLP and internal / external audits (HACCP, AIB, Personal Hygiene, Process audit) at Plant. 5) Communication to vendors in relation to the Root cause and failure analysis for deviations and follow up for the implementation of the corrective actions. 6) Ensure receiving of quality RM/PM material as per the FLI standards. Reporting of Deviation/Discrepancies to vendors/purchase and follow-up for the corrective and preventive steps. Responsibilities Accountabilities list in priority order the main accountabilities/deliverables of the role, including key measures. These should be clearly the responsibilities of the JOB HOLDER. Conducting quality checks of RM/PM material received in the plant to ensure that all FLI standards of quality are met. Monitoring RM/PM tests, reporting of non-compliance of service providers and communication about the corrective action. Maintaining accurate and comprehensive reports for communication to all the people concerned. Conducting regular audits of RM/PM stores for storage condition and FIFO/FEFO implementation. Ensure the smooth implementation of food safety policies at plant. 2) Ensuring best quality of RM/PM received in through quality checks and inspection. 3) Implementing right quality control systems/standards for the vendors / suppliers. 4) Responsible for ensuring the maintenance of implementation of GMP, GHK GLP and internal / external audits (HACCP, AIB, Personal Hygiene, Process audit) at Plant. 5) Communication to vendors in relation to the Root cause and failure analysis for deviations and follow up for the implementation of the corrective actions. 6) Ensure receiving of quality RM/PM material as per the FLI standards. Reporting of Deviation/Discrepancies to vendors/purchase and follow-up for the corrective and preventive steps. Qualifications B.Sc/ B.E./B.Tech/M.Sc - Food Technology B.Sc/ B.E./B.Tech/M.Sc - Food Technology Accountabilities list in priority order the main accountabilities/deliverables of the role, including key measures. These should be clearly the responsibilities of the JOB HOLDER. Conducting quality checks of RM/PM material received in the plant to ensure that all FLI standards of quality are met. Monitoring RM/PM tests, reporting of non-compliance of service providers and communication about the corrective action. Maintaining accurate and comprehensive reports for communication to all the people concerned. Conducting regular audits of RM/PM stores for storage condition and FIFO/FEFO implementation. Ensure the smooth implementation of food safety policies at plant. 2) Ensuring best quality of RM/PM received in through quality checks and inspection. 3) Implementing right quality control systems/standards for the vendors / suppliers. 4) Responsible for ensuring the maintenance of implementation of GMP, GHK GLP and internal / external audits (HACCP, AIB, Personal Hygiene, Process audit) at Plant. 5) Communication to vendors in relation to the Root cause and failure analysis for deviations and follow up for the implementation of the corrective actions. 6) Ensure receiving of quality RM/PM material as per the FLI standards. Reporting of Deviation/Discrepancies to vendors/purchase and follow-up for the corrective and preventive steps.

Role & responsibilities Preferred candidate profile

Vibonum Technologies, Bangalore is hring: Executive - AQA/QMS/DOC Cell Executive - IPQA/QMS Role & responsibilities Review and release the Finished products/Raw materials/ stability samples after the analysis in line with defined procedures. Review and approval of Qualification, validation documents, protocol, and reports. Initiation and / or Review and approval of QMS elements like Change controls, deviations, Out of Specifications, Out of Trends CAPA, etc. Management of Document cell (Issuance, retrieval archival and destruction of documents) to avoid any unauthorized access and usage of documents. Conduct training for newly joined Employee and existing employee and evaluate the effectiveness of the procedure. Review of batch documentation (BMRs, BPRs, COAs etc) manufactured and compilation of a complete set of batch documents required for batch release Perform the other activities assigned by the department Head. Preferred candidate profile Well-versed with OSD Manufacturing and Packing activities Sharp in Documentation and Review of shopfloor data Good communication and interpersonal skills EU/ TGA/ ANVISA regulatory audit exposure is an advantage Good knowledge of European agency guidelines Sound knowledge of ALCOA+ concepts and able to identify gaps w.r.t. ALCOA+ principles if any at shopfloor operations. Knowledge of the local language (Kannada) is an added advantage Perks and benefits: Best in the industry. Early joiining will first prference.

Responsibilities: Review of formulation development documents like trade dress for new product, feasibility report, justification for specification, scientific study protocol and report and pharmaceutical development report. Health insurance Provident fund

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 5 + year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor’s degree in computer science and engineering preferred, other Engineering field is considered Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals . Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

About The Role Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgen’s Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issues and addressing any business-critical escalations Research vendor information to determine appropriate contact for validation Conduct vendor outreach for vendor data validation Provide accurate, compliant and timely updates for validation outreach effort Manage outreach email box and respond/resolve issues in a timely manner Coordinate with Global team to ensure validations are performed in a timely manner Support Vendor Master escalation requests for master data maintenance related to blocking/unblocking vendor records and maintain overall master data integrity Understand the link between SAP, Ariba Cloud platform and the Ariba Network Support the monitoring and maintenance of vendor master data on a regular basis, to ensure data integrity and quality Provide regular reporting on Vendor Master data Continuously improve processes and procedures to enhance efficiency and effectiveness of the vendor master process. Supplier Enablement & Purchasing Catalogs Support connectivity of Suppliers to Amgen’s procurement systems Play a central role in managing supplier engagement for new catalog setup including preparing and testing new hosted catalogs and punch-out catalogs Support any ongoing monitoring and maintenance activities of catalogs, including monitoring catalog prices to ensure high accuracy of costs Communicate with local purchasing and technical teams and the supplier to resolve operational issues with catalogs. Provide related support to various stakeholders (e.g. answer questions, give requested support/advice, conduct trainings). Basic Qualifications Master’s degree OR Bachelor’s degree and 5 years of Finance experience OR Associate’s degree and 7 years of Finance experience OR High school diploma / GED and 10 years of Finance experience Preferred Qualifications 3+ years’ experience in Procure to Pay space, particularly working with master data and customer service SAP experience Ariba experience MS office proficiency especially Microsoft Outlook and Excel/CSV Ability to manage time to respond to incoming requests and prioritize appropriately to meet SLAs Motivated and responsive to changing priorities and deadlines Highly organized and reliable with strong attention to detail, verbal communication, and interpersonal skills Strong customer service focus while having a problem-solving attitude Ability to multi-task and work within tight timelines Work independently and take ownership of assigned activities Be a team player What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

QA Head Seeking a QA Head to ensure skincare products meet regulatory, safety, and quality standards. Work closely with manufacturing, R&D, and QC teams. Requirement: 4+ years of QA experience, preferably in cosmetics or pharma manufacturing. Required Candidate profile Skincare manufacturing & QC expertise Knowledge of FDA, GMP, ISO regulations Attention to detail & procedural compliance Strong analytical, problem-solving & com skills Ability to train & improve Jr.

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview As a senior Supplier Quality Engineer with over 6 years of hands-on experience in managing supplier with respect to quality, ensuring part conformance, handling customer complaints, and leading process improvements across diverse commodities including casting, PCB, plastic molding, rubber, and plating. Proven ability to implement robust incoming inspection systems, conduct supplier audits, and drive sustainable quality improvements that align with organizational goals. Responsibilities Lead incoming inspection activities; analyze data to identify trends and reduce defects. Coordinate with stores and production to ensure timely disposition of non-conforming materials. Implement process improvements to enhance efficiency and reduce inspection fatigue. Act as a point of contact for customer complaints related to supplied parts. Lead root cause analysis (RCA) and corrective/preventive action (CAPA) implementation. Ensure zero recurrence of customer complaints by driving robust countermeasures. Conduct supplier audits (System, Process, and Product audits) and follow-up for closure. Approve new suppliers through SQA assessments and sample qualification reviews. Negotiate and recover the cost of poor quality (COPQ) through chargebacks or rework agreements. Conduct periodic reviews and initiate improvement plans where required. Collaborate with R&D during new product development to ensure quality input is addressed. Work with manufacturing, logistics, and purchase to resolve supplier-related issues quickly. Education and Qualification Bachelor s degree in mechanical / production / industrial engineering or equivalent. Additional certifications in Quality (Six Sigma, VDA auditor, IATF etc.) preferred. Competencies ABOUT TE CONNECTIVITY TE Connectivity plc (NYSETEL) is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, energy networks, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 9,000 engineers, working alongside customers in approximately 130 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn , Facebook , WeChat, Instagram and X (formerly Twitter). WHAT TE CONNECTIVITY OFFERS: We are pleased to offer you an exciting total package that can also be flexibly adapted to changing life situations - the well-being of our employees is our top priority! Competitive Salary Package Performance-Based Bonus Plans Health and Wellness Incentives Employee Stock Purchase Program Community Outreach Programs / Charity Events IMPORTANT NOTICE REGARDING RECRUITMENT FRAUD TE Connectivity has become aware of fraudulent recruitment activities being conducted by individuals or organizations falsely claiming to represent TE Connectivity. Please be advised that TE Connectivity never requests payment or fees from job applicants at any stage of the recruitment process. All legitimate job openings are posted exclusively on our official careers website at te.com/careers, and all email communications from our recruitment team will come only from actual email addresses ending in @te.com . If you receive any suspicious communications, we strongly advise you not to engage or provide any personal information, and to report the incident to your local authorities. Across our global sites and business units, we put together packages of benefits that are either supported by TE itself or provided by external service providers. In principle, the benefits offered can vary from site to site. Location