840 Capa Jobs - Page 10

Responsibilities: * Manage quality systems implementation & documentation * Ensure compliance with ISO standards through audits & documentation * Collaborate on Capa initiatives within QMS framework Annual bonus Provident fund Mobile bill reimbursements

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 bridge any skill gap due to these changes. Mandatory Skills: L&P Policy Acquisition & Servicing. Experience: 1-3 Years.

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization

Role Purpose The purpose o central quality analyst role is to conduct quality audits and perform analytics in different areas as defined by central quality team, supporting the project teams in ensuring higher client satisfaction Do 1. Conduct process quality audits as per plan Conduct various process audits as per guidelines and SPOs defined in QMS Prepare findings from the report and share it with the account/ project 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 bridge any skill gap due to these changes 2. Conduct analysis, report generation and process compliance in different areas like metrics office, CAG, Process Definition Ensure processes to be followed in Wipro in terms of all quality norms in the areas of project management and highlight potential risks Provide insights and process guidance to the projects as per the need Prepare timely dashboards, reports, insights and share with the central quality and delivery teams to ensure minimum client escalation From time to time highlight any critical escalations where the central quality teams intervention is required in any BU project team Automate the report generations etc to ensure minimization of non-value added tasks, ensuring maximum utilization of existing platforms and their increased adoption Mandatory Skills: Data Centric testing.: Experience: 5-8 Years.

Note: Qualification: B.Tech / B.E. in Biomedical Engineering, Biotechnology, or related Medical Engineering field (Pharma background (B. Pharma / M. Pharma) profiles will not be considered) Mandatory Skills: Regulatory Affairs Medical Devices EU MDR compliance Design History File (DHF) Risk Assessment & Risk Management Familiarity with ISO 13485 and other applicable standards Key Responsibilities: Prepare, review, and manage regulatory submissions for medical devices (India and international markets) Ensure compliance with EU MDR (Medical Device Regulation) and local regulatory requirements Maintain and update Design History Files (DHF) , Technical Files, and Risk Management documentation Conduct risk assessments and support implementation of risk mitigation strategies Work closely with cross-functional teams R&D, Quality Assurance, and Product Development to ensure regulatory compliance Monitor changes in medical device regulations and assess their impact on company products Interface with regulatory bodies for product approvals and audits

-Check documents like packing sheets, Temp Records, Logger readings -Exp with CAPA documentation -Monitor & maintain the temperature systems -Provide training & prepare training records -Branch visit & perform self inspection activity for branches Required Candidate profile -Male/Female willing to travel (PAN INDIA) -Exp in food/pharma industry preferred -Exp in CAPA documentation is a MUST -Excellent verbal and written communication skills Perks and benefits PF, ESI, Mediclaim, Bonus, PL

Novo Nordisk Global Business Services (GBS) India Department GCM DP RoW Job Location Hyderabad Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global healthNovo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you''ll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). ! The Position As a Manufacturing Specialist (SME), you''ll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include: Lead cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. Act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Provide training, share best practices, and review and approve validation documents to safeguard compliance. Offer oversight and support during the planning and execution of validation and qualification activities. Define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. Drive problem-solving initiatives and provide scientific and technical solutions within tight project timelines. Qualifications Bachelor’s /Master’s degree in engineering. Possess 10+Years experience and relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. Capable of communicating naturally and effectively with stakeholders at all levels with adept at finding solutions and motivating stakeholders to achieve ambitious goals. Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail. Demonstrates the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. About the Department GCM DP RoW Projects is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you’ll join a diverse and dynamic team committed to making a difference.

The Deputy Manager - Quality Management System (QMS) is responsible for overseeing and ensuring the effective implementation, maintenance, and improvement of the Quality Management System within the PCC Digwal. The role involves meticulous management of documentation, adherence to regulatory requirements, and proactive involvement in quality-related processes. Key Responsibilities: Key Responsibilities: 1. Manage the ENSUR system for issuance and retrieval of SOPs, specifications, ATRA, worksheets, stability protocols, BMRs, BPRs, BFRs, etc., as per requirements. 2. Ensure adherence to document control procedures, including archival, retention, and destruction of documents as defined in the procedure. 3. Manage master and obsolete copies of SOPs, specifications, ATRs, worksheets, stability protocols, BMRs, BFRs, BPRs, etc. 4. Track SOPs, procedures, specifications, etc., for revision according to their validity period. 5. Responsible for archival management, including archival and retrieval of documents as required. 6. Perform login and review of quality management system documents such as change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 7. Track all quality management system documents till closure, including change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 8. Generate monthly tracking reports for quality management systems as per defined procedures. 9. Handle product quality complaints (Adverse Events) and medical inquiry reconciliation tracker for the Digwal site, coordinating with Pharmacovigilance team for adverse events as applicable. 10. Review and approve investigation reports, risk assessment reports, and ensure the implementation and effectiveness assessment of CAPAs. 11. Review quality system documents such as protocols, reports, procedures, APOR, trend analysis reports, continual process verification reports, etc., as required. 12. Share documents with the Regulatory Affairs department for filing updates based on change control implementation. 13. Prepare and review customer and external audit compliance reports. 14. Review and approve analytical reports such as batch analysis, standards, stability studies, etc. 15. Perform GMP verification and compliance review. 16. Ensure compliance with Safety, Health, and Environment (SHE) guidelines, rules, and regulations, including the usage of Personal Protective Equipment (PPE) where applicable. Qualifications: Bachelors degree in pharmacy, Chemistry, or related field. Master's degree preferred. 8-12 years of relevant experience in pharmaceutical Quality Assurance/QMS roles( API / API & Formulations ) Strong understanding of regulatory requirements and quality standards in the pharmaceutical industry. Excellent organizational, communication, and problem-solving skills. Ability to work effectively in a team and independently, with attention to detail and accuracy Skills: Proficiency in handling documentation and data management systems, particularly Harmony. Strong organizational skills with attention to detail and the ability to manage multiple priorities.

Actively involve during LIMS deployment, act as LIMS admin, aware about CSV LIMS data management, Mater data creator and static maintainer for LIMS. Shall perform assessment, and supporting to investigations, deviations and implementing CAPA effectively. Overall responsible for Internal & External vendor follow ups and completions within the timelines. Responsible to procure and maintain the minimum stock for working standards, reference standards, impurity standards, chemicals, reagents, glass wares and solvents required for analysis and ordering as and when required Responsible to complete the work assigned and ensure the training on the activity which are assigned by supervisor/ HOD-QC prior execution. Responsible for completing assigned tasks and ensuring training on activities as assigned by the supervisor/HOD-QC prior to execution. Review of packing materials, raw materials, stability samples, in-process data, and finished product data. Review qualification, validation, calibration data, procedures, and audit trails in a timely manner. Identify unsafe conditions or acts in the laboratory, report them to the supervisor/HOD-QC, and ensure appropriate action is taken to address them. Receive and inward analysis samples, including packing materials, raw materials, in-process samples, intermediates, APIs, finished products, and stability samples, and log entries in the respective AR number logs. Allocate tasks for chemical and instrumentation areas, ensuring timely completion. Ensure assigned tasks align with analyst qualification reports. Review QC logs, incident reports, and other records, ensuring proper document archiving after the release of samples. Oversee control sample inspection and ensure the proper disposal of leftover samples after analysis. Ensure instrument calibration and AMC are completed as per the schedule. Prepare and revise SOPs, specifications, and procedures in line with regulatory requirements. Conduct training on SOPs, trending, and other relevant procedures. Prepare stability schedules, stability protocols, and reports, as well as validation/qualification and trending reports. Participate in investigations and ensure the effectiveness of CAPAs. Perform SAP activities and ensure QMS closure before batch releases in SAP. Actively participate during LIMS deployment, act as LIMS admin, and manage LIMS data. This includes master data creation and static maintenance. Conduct assessments, support investigations and deviations, and implement CAPAs effectively.

We are hiring at SAEL Industries Limited for our upcoming Cell line project in Greater Noida, Uttar Pradesh location. Job Summary: C&I AGM/DGM for 5 GW TOPCon Cell Line manufacturing Position : Department Lead Key Responsibilities: Operational Management: Oversee the day-to-day operations and maintenance of all control and instrumentation systems (including SCADA, PLCs, DCS, HMI, sensors, field instruments). Ensure accurate process control , data acquisition, and alarm systems for critical process tools, utility equipment, and environmental systems . Drive implementation and maintenance of cleanroom monitoring systems , tool interlocks , and gas detection interfaces for specialty/bulk gas systems. Establish and sustain calibration schedules for pressure, temperature, flow, level instruments, analyzers, and transmitters. Team Leadership: Lead and manage a team of instrumentation engineers and technicians responsible for installation, troubleshooting, and system optimization. Define training plans, SOPs, and knowledge-sharing platforms to enhance skill levels within the C&I team. Promote safety, accuracy, and proactive diagnostics culture across all instrumentation tasks Performance Monitoring Monitor KPIs related to instrumentation uptime, data integrity, response time , and calibration compliance. Perform root cause analysis (RCA) and implement corrective and preventive actions (CAPA) for system failures or drift. Improve control loop tuning, sensor placement , and data logging efficiency to optimize process reliability and yield. Drive digital transformation and Industry 4.0 readiness through integration of smart instruments and real-time analytics. Project Management: Lead the planning, design, procurement, installation, and commissioning of C&I systems during the greenfield phase. Review and approve control philosophies, loop diagrams, cable schedules, hook-up drawings , and I/O lists. Coordinate with EPCs, OEMs, automation vendors, and internal project stakeholders to ensure proper integration and timely handover. Implement SCADA/HMI systems , including configuration, server setup, and database management for process & utility dashboards. Stakeholder Communication: Liaise with production, process, utilities, EHS, IT, and automation teams to ensure synchronized operations and response readiness. Coordinate with OEMs, calibration agencies, system integrators, and external auditors to support project and operational requirements. Provide timely updates to management on instrumentation health, risk areas, improvement plans , and compliance status. Qualification B.E./B.Tech in Instrumentation / Electronics / Electrical & Instrumentation / Control Engineering Certifications in PLC/SCADA, ISA standards, Fieldbus protocols, HART/Modbus , or Industrial IoT are preferred. Preferred candidate profile 1220 Years (preferably in semiconductor, solar, or high-tech manufacturing industries)

The Quality Assurance Manager (ISO/IEC 17025:2017) position requires a minimum of 5-7 years of experience and a Bachelors Degree (or higher) in Chemistry, Biochemistry, Food Science/Technology, Analytical Chemistry, Chemical Engineering, or related disciplines. The role is based in Bagru, Rajasthan. As the Quality Assurance Manager, your primary responsibility is to ensure the lab's Quality Management System (QMS) complies with ISO/IEC 17025:2017 and other regulatory requirements. This involves managing audits, maintaining lab safety and equipment, resolving customer complaints, and driving continuous improvement. Key Responsibilities: - Implement and maintain ISO/IEC 17025:2017 QMS and ensure GLP compliance. - Manage client and regulatory audits and address findings. - Oversee lab operations, safety, equipment, and records. - Review and approve deviations, change controls, and CAPA. - Resolve customer complaints and gather feedback for system improvements. - Conduct performance reviews and monitor quality tools (ILC, PT, IQC). - Provide training on ISO/IEC 17025:2017 and quality practices. Required Qualifications & Skills: - Bachelors Degree (or higher) in a relevant field. - 5-7 years of experience in quality assurance within a lab. - Strong knowledge of ISO/IEC 17025:2017 and GLP. - Excellent leadership, communication, and decision-making skills. - Experience with audits, CAPA, and safety procedures.,

Deployment of QA Improvement Plans for Customer Awards in plant Review of deployment of QMS requirements across all processes within plant Conducting and Review of Internal systems (IATF/MSM) audits Coordinating Customer QAV audits New DOJO set up,

Responsibilities: * Lead cross-functional teams on complex projects from concept to delivery. * Develop and implement process improvements through CAPA, FMEA, and QMS methods. Travel allowance Maternity policy Annual bonus Leave encashment Provident fund

Job Title: Quality Inspector - GD&T / 2D / Gauges / CMM Department: Quality Assurance Location: GUDAPAKKAM, (Poonamallee - Tiruvallur High Road) Reports To: Quality Team Leader / Quality Manager Purpose of the Role:- To perform quality checks and inspections on products and components to ensure they meet specified standards and engineering drawings. The Quality Inspector will utilize GD&T principles, interpret 2D diagrams, and use precision measuring instruments to verify product compliance. Role & responsibilities:- Inspect incoming, in-process, and finished parts using precision measuring tools. Interpret and apply Geometric Dimensioning and Tolerancing (GD&T) standards. Review and understand 2D engineering drawings and specifications. Use variable gauges , micrometers, calipers, height gauges, bore gauges, and other quality instruments to measure dimensions and tolerances. Document inspection results and maintain accurate quality records. Identify and report non-conformities, support root cause analysis, and recommend corrective actions. Support audits and continuous improvement initiatives as required. Preferred candidate profile :- Qualification: Diploma / BE in (Mechanical / Automobile / EEE / ECE) Engineering or equivalent. Experience: 13 years in a manufacturing or engineering quality role preferred. Strong understanding of GD&T and mechanical inspection techniques. Proficiency in reading 2D technical drawings . Hands-on experience with quality instruments and variable gauges . Good communication, problem-solving, and reporting skills. Contact HR - 98843 05167 / 98840 49633 Mail - hr1@crownqualityservices.com

Job Role: Execute and monitor QMS (ISO 9001) IATF 16949 processes. Perform Incoming, In-process & Final inspection as per quality plans. Maintain inspection records, control plans & process documents. Support internal audits, customer audits & supplier evaluations. Handle non-conformances, root cause analysis & corrective actions. Support continuous improvement and 5S implementation. Key Skills: Knowledge of QMS (ISO 9001), 7 QC Tools, CAPA, 5Why. Experience with measuring instruments (Vernier, Multimeter, LCR Meter, etc). Good analytical & problem-solving skills. Knowledge of electronics manufacturing

Filling & review BMRs, MFRs, SOPs, ECR Maintain records for CC, CCF Ensure documentation aligns with GMP Requirement Support audits & investigations with accurate records. Coordinate with production & QA for data verification. Required Candidate profile Must Require Knowledge for filling & Review of BMR BMR, CC, CCF, and OOS handling Documentation practices & regulatory understanding Good communication & MS Office proficiency

Responsibilities: * Conduct internal audits & customer audits. * Prepare audit documentation & system audit reports. * Ensure compliance with ISO standards & customer *Maintain Auditing of Documentation under Q.M.S ISO 14000 and 45000. Onsite creche facility Shift allowance Travel allowance House rent allowance Health insurance Provident fund Annual bonus

Interested candidates can apply here and share resumes at mridula@symbiosisindia.net . Job Description : Lead preventive and corrective maintenance of mechanical equipment. Monitor and control CAPEX projects, daily maintenance, and inventory costs. Drive sustainability and resource conservation initiatives. Plan and execute equipment shutdowns with minimal downtime. Conduct breakdown analysis and implement CAPA. Ensure compliance with ISO, TS 16949, OHSAS, EMS, TPM, and safety norms. Manage procurement, RFQs, and PRs for maintenance-related items. Handle manpower planning, shift scheduling, and training needs. Perform electrical safety officer duties and maintain audit readiness. Promote team discipline, skill development, and continuous improvement. Identifying training needs and fostering team spirit across the department.

As a Manager at Dishman Carbogen Amcis Limited, located in Bavla, Gujarat, IN, your role will involve being responsible for ensuring plant readiness 24X7 for inspection, with exposure to regulatory audits. You will need to have a strong knowledge of CC/Deviation/CAPA/OOS/OOT/risk assessment/GDP, as well as Unit process/operation and manpower management. In this role, it is crucial to follow safety guidelines set by management and possess SAP knowledge. Your responsibilities will include overseeing quality assurance processes, legal compliance, and effective ERP implementation. If you are someone with experience in inspector roles, law, CAPA, ERP, SAP, quality management, and technology, this position offers a challenging yet rewarding opportunity to contribute to the success of the Contract Manufacturing business unit.,

As a Clinical Quality Assurance professional at WPPL, you will play a crucial role in ensuring the establishment, implementation, and maintenance of processes required for the Quality Management System. Your responsibilities will include reporting on the performance of the quality system, planning and executing clinical activities, and conducting various audits across departments. You will be responsible for reviewing equipment installation, qualification, calibration, and preventive maintenance in the clinical department, ensuring compliance with relevant SOPs and guidelines. Additionally, you will review clinical data, pharmacokinetic analysis, statistical output, and statistical analysis reports to ensure accuracy and adherence to protocols. As part of your role, you will conduct external vendor audits, review raw data of clinical projects, and perform internal study audits to assess compliance with GCP/GLP, protocols, SOPs, and regulatory requirements. You will also review and evaluate change controls, deviations, CAPAs, and conduct facility assessments at clinical and pathology laboratories. Collaborating with the Head-QA, you will support regulatory inspections and audits, review responses to queries, and ensure timely implementation of CAPA actions based on investigative results. Additionally, you will update policies, quality manuals, SOPs, and work documents, providing valuable insights and comments for their approval. Your role will involve monitoring studies at external CROs, conducting meetings with clinical and pathology laboratory departments to update on quality systems, and taking on other responsibilities as assigned. With your M.Sc, M.Pharm, or Ph.D. qualification and 8-10 years of experience in Clinical Quality Assurance for BA/BE studies, you will report to the Associate Director Quality Function. Join us at WPPL and be part of a mission-driven team dedicated to making a positive impact on global healthcare by ensuring quality and compliance in clinical activities and processes.,

Manage the Quality Assurance function at manufacturing site Ensure compliance with ISO, GMP & REACH standard Develop, implement & monitor Quality Management Systems including SOPs, documentation & CAPA systems Handle customer complaints, conduct RCA Required Candidate profile 10-12 years of experience in QA, preferably in specialty chemicals Knowledge of analytical instruments, QC processes & technical documentation Strong knowledge -ISO 9001, GMP & other quality standards

Roles and Responsibilities Conduct quality audits, call monitoring, and root cause analysis to identify areas for improvement. Develop and implement corrective actions (CAPA) to address non-conformities found during audits. Collaborate with cross-functional teams to ensure compliance with quality management systems (QMS). Provide feedback on customer quality issues and work closely with customers to resolve them. Utilize various quality tools such as Pareto analysis, RCA, QC tools, Call Calibration, Feedback, etc. to drive continuous improvement. Desired Candidate Profile 3-8 years of experience in a similar role within the BPO industry. Strong understanding of Quality Management principles and practices (ISO 9001:2015). Excellent communication skills for effective collaboration with internal stakeholders and customers. Ability to analyze data from various sources using tools like 7QC, Call Monitoring, Call Quality etc. Total Experience: 5 Yrs As Assistant Manager: 1.5 Yrs BPO experience is mandatory Work location: Kolkata Interested candidates can apply here puja.vishwakarma@startek.com

Efficiently monitor all operations which affect the quality. Devise procedures for inspecting and reporting all the persisting quality issues. Assure the consistency and reliability of production with thorough checking procedures and final output. Supervise and guide inspectors, technicians, and all other staff. Report all malfunctions to production executives only to ensure immediate action. Appraise all the requirements of customers and ensuring they are quite satisfied. Facilitate proactive solutions by collecting and analyzing quality data. Keep permanent records of quality reports, statistical reviews, and relevant documentation. Review the current standards and policies. Communicate with external quality assurance officers during on-site inspections. Efficiently ensure that all the legal standards are met with great care. Provide assistance during the recruiting process. Efficiently create reports for tracking progress.Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.

Role & responsibilities Preferred candidate profile Perks and benefits

To ensure that quality standards are maintained during the manufacturing process, monitoring and improving in-process quality control activities, reducing defects, and ensuring adherence to customer specifications.