2277 Capa Jobs - Page 28

As the Head of Quality Assurance and Compliance at our Biopharmaceutical company, your role will be crucial in maintaining the highest standards of quality, compliance, and regulatory adherence. Reporting directly to the executive leadership team, you will play a critical role in upholding and enhancing our reputation for excellence in the industry. **Role Overview:** You will be responsible for establishing and maintaining robust Quality Systems to support cGMP activities, ensuring compliance with regulatory requirements and industry standards. Your role will involve managing the Quality Control and Quality Assurance departments, overseeing document control and training systems, and leading...

As a Process Engineer, your role involves leading investigations and root cause analysis of OS&D events to ensure timely closure of deviations and effective implementation of CAPAs. You will drive process optimization projects aimed at reducing material variances, overages, and production losses across facilities. Collaboration with cross-functional teams including QA, QC, SCM, Manufacturing, and Engineering is essential to improve systems for material handling, storage, and reconciliation. Your responsibilities will also include establishing metrics and dashboards to track OS&D trends and performance improvement. Implementing risk assessment tools such as FMEA and RCA will be crucial in pro...

Manage all the shop floor activities which includes House Keeping, Safety audits and Equipment Inspection & Maintenance. Develop and implement vendor AMCs with appropriate service levels for equipment. Manage day to day issues on equipment with the Operations teams, defining Priorities with Operation, and organize the work with his team. Preparing Department KPI and ensuring the goals and objective completed in time bound. Conducting Monthly Review Meeting to know the performance of the department. Preparation of RCFA of breakdown and complete all its CAPA on time. SOP making and conduct training so as to maintain standard practices and also increase the competency level of employees and ven...

Role & responsibilities Job Title: SAP QM Functional Consultant Location: Hyderabad Experience: 46 years Employment Type: Full-Time About the Role: We are seeking an experienced SAP QM Functional Consultant to join our team. The ideal candidate will have a strong background in implementing, configuring, and supporting SAP QM modules within pharmaceutical, life sciences, or manufacturing environments. You will work closely with business stakeholders, cross-functional teams, and technical experts to deliver high-quality SAP solutions, ensure regulatory compliance, and continuously improve quality management processes. Key Responsibilities: Gather business requirements, design solutions, and de...

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team. The ideal candidate will have expertise in ServiceNow and HPALM. Roles and Responsibility Manage and implement CSV solutions using ServiceNow and HPALM. Collaborate with cross-functional teams to ensure seamless integration of CSV with other systems. Develop and maintain documentation for CSV processes and procedures. Troubleshoot and resolve issues related to CSV implementation. Provide training and support to end-users on CSV tools and features. Ensure compliance with industry standards and best practices for CSV management. Job Requirements Strong knowledge of ServiceNow and HPALM. Experience in managin...

We are looking for a skilled SAP CRM-C4C professional with 9 to 20 years of experience. The ideal candidate will have expertise in SAP C4C and be able to work effectively in a fast-paced environment. Roles and Responsibility Manage and implement SAP C4C solutions for clients. Collaborate with cross-functional teams to identify business requirements and develop solutions. Provide training and support to end-users on SAP C4C functionality. Troubleshoot and resolve technical issues related to SAP C4C. Develop and maintain documentation of SAP C4C configurations and customizations. Ensure data integrity and security in SAP C4C implementations. Job Requirements Strong knowledge of SAP C4C modules...

Job Description Role Purpose The purpose of this role is to conduct audits to ensure quality compliance within the account. Do Conduct process quality audits as per plan Conduct various process audits (1 audit/ agent/ week) as per procedure and guidelines For agents identified in the bottom quartile of performance, conduct 3 audits/ agent/ week Prepare findings from the report and share it with the client and the account leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to brid...

Requisition for Executive for the implementation and monitoring of GLP in TIC. Skills Required : Good Laboratory Practice, Quality Assurance, MS Office Package, Communication Skills Roles and Responsibilities : Preparation of documents related to applying GLP (Good Laboratory Practices). Ensure the upkeep and maintenance of the laboratory by implementing GLP. Ensure compliance with GLP standards. Logbook management, sample management, SOP management, and other document management related to GLP. Any other work related to Quality assurance assigned by the manager. GLP-trained person or experience working in GLP labs. Must have good verbal and written skills.

Role & responsibilities Pantnagar Role : Part Revalidation at Supplier End CAPA (Corrective and Preventive Action) Follow-up Supplier Coordination Pantnagar Role & Alwar Role : Green Part & Red Part Inspection Line Issue Addressal Daily In-Process & Final Product Inspection Use of Measurement Instruments (Vernier, Micrometer, Height Gauge, etc.) Quality Documentation & Reporting Root Cause Analysis & Implementation of Corrective Actions Compliance with ISO 9001 / IATF 16949 standards Preferred candidate profile Diploma / Degree in Mechanical, Production, or Industrial Engineering 2 to 4 years of relevant experience in Quality Inspection and Supplier Quality Exposure to Manufacturing / Automo...

Role & responsibilities To be well versed about coordination and collaboration with Quality functions of third party manufacturing (CMO) sites and CMO team for compliance of product, facility, systems, procedures. and for documents required from third party for various purpose; review, RA submission etc. Must have knowledge and know how on regulatory pathway for registration of product as per third party and or loan license norms/rules and requirement of documentation for regulatory submissions. Incumbent is expected a good reviewer and investigator To know the function of oversight of CMO sites for batch/lot releases as applicable form the manufacturing (Feed supplements and Pharma products...

Job Description Position: Manager – Quality Control & Assurance Industry: Metal Forging (serving Heavy Duty Industry Construction Equipment, Off-Highway Vehicles, Oil & Gas, Railways, Power Sector, Automotive, Boeing etc.) Reports To: Head – Quality / Plant Head / General Manager Role Summary: The Manager – Quality Control & Assurance is responsible for leading and managing the entire quality function, covering incoming, in-process, and final inspection of forged products. The role ensures metallurgical and dimensional compliance of forgings with customer specifications, standards, and heavy-duty application requirements. The position involves setting quality policies, establishing robust in...

Oversee, mentor and guide Senior Specialists in IPS, to ensure high-quality safety deliverables across the team. Contribute to/Lead the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures. Safety mailbox and communications management. Support/Lead Aggregate Report related activities. Lead the creation/update of PV Awareness and other related Training content. Implementation of Pharmacovigilance Agreements. Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees. Safety Data Quality activities e. g. PV Sys...

Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team i...

Act as a liaison between Quality Operations, IT, and business stakeholders to gather, analyze, and document requirements related to Veeva Vault Quality applications. Drive process improvements and system enhancements to optimize the use of Veeva Vault for Quality Management. Support the implementation and ongoing maintenance of Veeva Vault Quality modules aligned with regulatory and business needs. Key Responsibilities: Collaborate with Quality, Compliance, and IT teams to understand business processes and translate them into system requirements for Veeva Vault Quality Operations. Gather, analyze, document, and validate comprehensive business and functional requirements to support system enh...

Provide operational and technical support for the Veeva Vault Quality platform. Collaborate with Quality, Compliance, and IT teams to ensure smooth functioning of Veeva Vault applications. Assist in maintaining and enhancing the Vault environment to meet business and regulatory requirements. Key Responsibilities Key Responsibilities Support day-to-day operations of Veeva Vault Quality modules (e.g., QualityDocs, QMS, Audit, Issues, Inspections, Complaints, Change Control). Troubleshoot and resolve user issues related to Vault Quality applications. Manage user access, roles, and permissions within Veeva Vault. Assist in configuration and administration of Vault workflows, lifecycles, and meta...

The Quality Engineer ensures that automotive components meet internal and customer quality standards throughout the production lifecycle. This role involves implementing quality control systems, conducting audits, analyzing defects, and driving continuous improvement initiatives to enhance product reliability and customer satisfaction. Preferred candidate profile B. Tech (Mechanical) with 2-5 years experience in Quality Department from auto parts industry

Candidate should have Experience in Sheet Metal industry Maintain QMS (IATF 16949, ISO 9001) Lead the preparation and revision of quality manuals, procedures, work instructions Act as the main point of contact for OEM and Tier-2 customerquality teams Required Candidate profile Technical Proficiency * PPAP, APQP, FMEA, SPC, MSA * Use of precision measuring instruments (e.g., Vernier callipers, micrometres, * CMM, gauges) * Familiarity with quality tools & software.

Job Description: We are seeking a detail-oriented and analytical Yield/Quality Engineer to join our team. The ideal candidate will be responsible for monitoring, analyzing, and improving product quality and manufacturing yield. You will collaborate closely with manufacturing, process engineering, design, and quality assurance teams to identify root causes of defects, implement corrective actions, and drive continuous improvement initiatives that enhance product reliability and production efficiency. Key Responsibilities: Monitor and analyze manufacturing yield data and quality metrics to identify trends and areas for improvement. Conduct root cause analysis (RCA) of product failures, defects...

Role & responsibilities To execute CAPA management for respective accounts, To initiate CAPA in ETQ system as per timeline. To do root cause analysis as per procedure To Implement corrective and preventive actions To do Effectiveness review To prepare CAPA Action plan and share to regional Quality officer for review To maintain CAPA Log to track CAPA for timely closure To initiate Change control in ETQ system and Maintain Change control log as per SOP To identify and initiate deviation, submit deviation to regional Quality officer for review and close the deviation as per procedure To Prepare and maintain housekeeping checklist, Pest control service records, warehouse trap and flycatcher che...

We are looking for a skilled professional with 4 to 8 years of experience in system integration testing to join our team. The ideal candidate will have a strong background in ISO 26262 and ASPICE SYS4 standards. Roles and Responsibility Conduct system integration testing in compliance with ISO 26262 and ASPICE SYS4 standards. Set up and configure test environments for executing integration test cases. Review system architecture to ensure testability and traceability. Implement manual, automated, and semi-automated test cases across various environments. Apply structured review techniques such as peer review, walkthrough, and inspection. Execute test cases according to the defined test plan a...

Job Description 1. Monitor raw material dispensing activity. 2. Perform daily IPQA activities as per SOP-defined frequency and ensure timely closure of IPQA observations. 3. Conduct validation sampling as per approved validation protocols. 4. Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy and compliance. 5. Perform ERP-related transactions of IPQA. 6. Check BSR (Batch Summary Record) and Shipper inspection as per SOP. 7. Manage issuance, review, and reconciliation of formats across all departments. 8. Conduct IPQA rounds and share observations with concerned HODs for corrective action and compliance. 9. Ensure cleaning, sanitation, and hygiene in all depa...

Job Title: Sr. Executive/Executive Department: DQA Job Summary, Duties/Responsibilities: Ensure proper guidance on quality issues to the Product Development Teams Review the documents received from R&D, AR&D, etc. so that the same can be shared with authorities and customers . coordination communication and to respond customer complaint/query and regulatory authority. Review the process change proposals and help the team members provide guidance on change proposals Review the in-house expert reports/Quality overall summary (QOS) prepared by the team members Ensure proper stage gate compliance at various stages of product development Ensure that internal audits are conducted properly Review t...

Responsible for Operation & maintenance and daily monitoring of Utilities & Process Equipments (like Vial Line lyophilizers etc.). Responsible for review the daily logbooks of utility, lyophilizers and process equipment's and update all PM status label. Maintain the lyo related all activities Operation, Maintenance, Cleaning & Documentation. Maintain the lyo related all critical spares and consumable stock. Responsible for maintenance and troubleshooting of lyophilizer. Responsible for preparation of URS, PR and TR for lyophilizer etc. as per cGMP requirements. Responsible for preparation, Implementation and Compliance of all related SOPs. Responsible for preparation and handling of QMS docu...

As a Head Quality Assurance (QA) at Instrumentation & Control Solutions in Indore, your role will involve leading and managing Quality Assurance activities in the pharmaceutical unit. Your primary focus will be to ensure compliance with cGMP, regulatory standards such as WHO-GMP, USFDA, EU, and internal QMS protocols. Key Responsibilities: - Lead QA operations, including documentation, audits, and compliance. - Handle deviations, CAPA, OOS investigations, and regulatory audits effectively. - Oversee the development and maintenance of SOPs, validations, and training programs. - Ensure the robust implementation of Quality Management Systems to maintain high-quality standards. Qualifications Re...

As a Manufacturing Manager at Pfizer, your role will involve overseeing the manufacturing of sterile dosage products. You will be responsible for various key activities including: - Facilitating investigation processes, proposing and implementing Corrective and Preventive Actions (CAPA). - Demonstrating knowledge of DMAIC and ALCOA principles. - Managing equipment, technologies, and unit operations involved in liquid injectable manufacturing. - Engaging and inspiring the team to meet performance expectations and coaching them using Coaching Skill principles. - Overseeing critical area management and governing clean room behavior and practices. - Implementing process and cleaning equipment va...