34 Capa Management Jobs

The Senior Manager QMS will lead the development, implementation, maintenance, and continuous improvement of the company's ISO 13485-compliant Quality Management System across multiple manufacturing and support units. This role is critical to ensure consistent product quality, process efficiency, global regulatory compliance readiness, and a strong quality culture across the organization. Key Responsibilities: QMS Governance & Compliance Lead the organization-wide implementation and maintenance of ISO 13485:2016 , 21 CFR Part 820 , Schedule V MDR 2017 , and MDSAP -aligned QMS. Ensure all quality-related processes, documents, and records are compliant and audit-ready at all times. Conduct and...

Location: RG Plant, Pune, India Function: Corporate Quality Reports to: Country Quality Leader, 3M India Job Summary As a Corporate Quality Manager at 3M India, you will play a vital role in advancing our corporate quality objectives. You will be responsible for overseeing and strengthening Quality Management Systems (QMS), managing supplier complaints, handling quality holds, and ensuring compliance with regulatory standards such as BIS QCO and label requirements. Additionally, you will support initiatives like shelf-life management, product lifecycle governance including new product introductions and change management and drive key quality improvement metrics across India operations. You w...

Location: Delhi | Experience: 58 years | Employment Type: Full-time Are you passionate about food quality and safety, and ready to lead quality initiatives in a fast-growing premium fresh food brand Join Pluckk as a Lead Quality , where you'll play a pivotal role in building and maintaining our high standards across production and supply chain operations. About the Role: As a Quality Lead , you'll oversee food safety and quality assurance systems end-to-end from raw materials to finished products. You'll lead audits, mentor QA teams, and drive continuous improvement initiatives to ensure compliance, consistency, and consumer trust. Key Responsibilities: Lead quality assurance processes acros...

Role Overview: Working at Bristol Myers Squibb offers you challenging, meaningful, and life-changing experiences every day. You will have the opportunity to be part of uniquely interesting work that transforms the lives of patients and your career. The company provides a work environment that values balance and flexibility, offering competitive benefits, services, and programs to support your personal and professional goals. Key Responsibilities: - Identify opportunities for process improvements related to CAPA management by analyzing current workflows, systems, and procedures. - Lead cross-functional teams in driving process improvement projects from start to finish. - Manage the CAPA proce...

As a Quality Assurance GLP professional at MSCR, your role involves ensuring the highest standards of quality and compliance across clinical research and laboratory operations by leveraging your expertise in ICH-GCP and GLP principles. You will be responsible for various key activities: - Develop and maintain ICH/GCP-compliant processes at MSCR. - Lead internal quality audits, CAPA activities, and quality management reviews. - Conduct study audits to ensure adherence to sponsor protocols, GCP, and regulatory requirements. - Identify non-conformances, recommend corrective measures, and drive continuous quality improvements. - Perform vendor audits, collaborate with production support teams, a...

Job Title: Quality Assurance (QA) Clinical Research Experience: 810 years Location: Indiranagar, Bangalore Department: Quality Assurance About the Role MSCR is seeking an experienced QA professional with strong expertise in ICH-GCP and GLP principles to ensure the highest standards of quality and compliance across clinical research and laboratory operations. The ideal candidate will be well-versed in regulatory guidelines, clinical QA processes, and GLP compliance, with proven experience in audits, CAPA management, and continuous quality improvement initiatives. Key Responsibilities Clinical QA (ICH-GCP Focus) Develop and maintain ICH/GCP-compliant processes to control the quality of work an...

Role & responsibilities Responsible for developing, establishing, and maintaining QA procedures related to clinical trials to ensure compliance with applicable regulatory guidelines. Review of clinical trial-related documents such as Investigators Brochure, Clinical Trial Protocol, Informed Consent Document, and associated plans and manuals. Ensuring the conduct of clinical trials as per applicable guidelines, SOPs and protocols. Responsible for planning, conducting and reporting of audits pertaining to study. Conduct of facility audits for its compliance and for ensuring CAPA implementation. Conduct of site audits and TMF audits as per study protocol, to generate reports and ensure CAPA imp...

Skills: GMP Compliance, CAPA Management, Validation Protocols, QMS, Quality Auditing, Standard Operating Procedures, Job Title: Head Quality Assurance (QA) Location: Indore- Company: Instrumentation & Control Solutions Experience: 5+ years in Pharma QA Job Type: Full-Time Job Description We are hiring a QA Head to lead and manage Quality Assurance activities in our pharmaceutical unit. The ideal candidate will ensure compliance with cGMP, regulatory standards (WHO-GMP, USFDA, EU, etc.) and internal QMS protocols. Key Responsibilities Lead QA operations including documentation, audits, and compliance. Handle deviations, CAPA, OOS investigations, and regulatory audits. Oversee SOPs, validation...

Responsible for microbiological testing in accordance with standard procedures. Manage and supervise assigned production line(s). Lead Corrective Action/Preventive Action (CAPA) for microbiological non-conformities. Develop, implement, and monitor laboratory methods and conduct document reviews. Oversee incoming testing of ingredients. Lead CAPA for microbiological and incoming quality non-conformities. Represent incoming quality assurance during all external quality and regulatory audits. Assess and drive continuous improvement in laboratory efficiency and productivity. Manage department budget and implement cost improvement plans related to lab and microbial testing. Serve as a technical r...

Responsible for microbiological testing as per standard procedures. Manage and supervise assigned production line(s). Lead Corrective Action/Preventive Action (CAPA) for microbiological non-conformities. Develop, implement, and monitor laboratory methods and documentation reviews. Manage incoming testing of ingredients. Lead CAPA for microbiological and incoming quality non-conformities. Represent the incoming quality assurance function during external quality and regulatory audits. Assess and drive continuous improvement in laboratory efficiency and productivity. Manage the department budget and implement cost improvement plans related to the lab and microbial testing. Serve as technical re...

It's more than a job When you work in Freight Logistics and Operations at Kuehne+Nagel, you play a key role in optimising processes and ensuring that inventory and shipments move efficiently. But that is not all. Your work also helps ensure that vital medicines reach patients on time and supports other essential deliveries, from wind turbines to semiconductors. At Kuehne+Nagel, our contribution counts in more ways than we imagine. ? The IL Quality Manager is an integral part of the Kuehne+Nagel Integrated Logistics (KN IL) Team and is responsible for providing expertise and necessary controls in the supply chain process in the area of quality and compliance throughout the supply chain. This ...

As a Manager - Quality at Dishman Carbogen Amcis Limited, located in Bavla, Gujarat, your role will involve the following responsibilities: - Handling of Change control - Handling of Deviation and CAPA management system - Handling of Internal and external audits - Sound knowledge about Equipment and Utility qualification - Should have thorough understanding about regulatory guidelines, cGMP norms, GLP, GDP, Data integrity requirements etc. - Should have experience of regulatory audits The company, Dishman Carbogen Amcis Limited, operates in the General business unit and is committed to maintaining high quality standards in accordance with regulatory requirements.,

Title: Manager - Quality Custom Field 2: 2490 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Handling of Change control, Handling of Deviation and CAPA management system, Handling of Internal and external audits, Sound knowledge about Equipment and Utilty qualifcation, Should have thorough understanding about regulatory guidelines, cGMP norms, GLP, GDP, Data integrity requirements etc. Should have experience of regulatory audits. Job Segment: Quality Manager, Law, CAPA, Manager, Quality, Legal, Management

As a candidate for the position, your main responsibility will be to establish and maintain relationships with CMO/ CDMO manufacturing organizations. This includes developing and maintaining strong, collaborative relationships to ensure successful product manufacturing, process development, and scale-up activities. You will also provide technical expertise and guidance to CMOs on process optimization, scale-up, and troubleshooting. Supporting the transfer of new products or processes to external manufacturing sites will also be part of your role. Key Responsibilities: - Monitor the performance of external manufacturing partners and identify opportunities for improvement. - Track the ongoing ...

Job Title: Quality Assurance (QA) Clinical Research Experience: 810 years Location: Indiranagar, Bangalore Department: Quality Assurance About the Role MSCR is seeking an experienced QA professional with strong expertise in ICH-GCP and GLP principles to ensure the highest standards of quality and compliance across clinical research and laboratory operations. The ideal candidate will be well-versed in regulatory guidelines, clinical QA processes, and GLP compliance, with proven experience in audits, CAPA management, and continuous quality improvement initiatives. Key Responsibilities Clinical QA (ICH-GCP Focus) Develop and maintain ICH/GCP-compliant processes to control the quality of work an...

As an experienced Quality Assurance (QA) professional with 8-10 years of experience in clinical research, pharmaceuticals, or life sciences, you will play a crucial role in ensuring the highest standards of quality and compliance at MSCR. Your expertise in ICH-GCP and GLP principles will be essential to maintain regulatory guidelines, clinical QA processes, and GLP compliance throughout the organization. Key Responsibilities: - Develop and maintain ICH/GCP-compliant processes to control the quality of work and clinical studies at MSCR. - Lead and manage internal quality audits, CAPA activities, and quality management reviews. - Conduct study audits to ensure adherence to sponsor protocols, G...

Job Description Major Accountability: Adherence to the current GxP and compliance requirements of Sandoz, perform and deliver Quality Operations in support of product quality compliance and regulatory workflows. Ensure compliance to the Sandoz quality standards, relevant regulatory requirements, filed product quality standards and service level agreements. Support implementing service quality and process improvement projects, CAPA management within GQSI. Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes. Regularly communicate with customers and partners to collect feedback on support services, report de...

Role Overview: As a Quality Operations Support at Sandoz, your primary responsibility is to ensure compliance with current GxP and regulatory requirements while delivering quality operations to maintain product quality compliance and regulatory workflows. Your role involves upholding Sandoz quality standards, relevant regulatory requirements, filed product quality standards, and service level agreements. Additionally, you will play a key role in supporting the implementation of service quality and process improvement projects, as well as managing CAPA within GQSI. It is vital to adhere to internal functional requirements, including KPI reporting, ticket management tools, and other internal p...

Job Description As the Head of Quality Assurance at Instrumentation & Control Solutions in Indore, you will be responsible for leading and managing all Quality Assurance activities within the pharmaceutical unit. Your primary focus will be to ensure compliance with cGMP, regulatory standards such as WHO-GMP, USFDA, EU, and internal Quality Management System (QMS) protocols. Key Responsibilities - Lead QA operations, overseeing documentation, audits, and ensuring compliance. - Manage deviations, Corrective and Preventive Actions (CAPA), Out of Specification (OOS) investigations, and regulatory audits. - Supervise Standard Operating Procedures (SOPs), validations, and training programs. - Ensu...

Exp. in IPQA, line clearance & digital documentation w/ E-BMR & E-Log. Equipment qualification & process validation, w/ an understanding of 21 CFR Pt. 11 & audits. Risk assessment, CAPA management & conducting internal & vendor audits. Tech Transfer Required Candidate profile 10-15 Yrs B. Pharma / M. Pharma

Exp. in IPQA, line clearance & digital documentation w/ E-BMR & E-Log. Equipment qualification & process validation, w/ an understanding of 21 CFR Pt. 11 & audits. Risk assessment, CAPA management & conducting internal & vendor audits. Tech Transfer Required Candidate profile 10-15 Yrs B. Pharma / M. Pharma

Role & responsibilities Harmonize QA SOPs and formats of MSN API divisions into corporate procedures in line with global regulatory guidelines (ICH, 21 CFR, EU, WHO). Prepare and distribute CQA SOPs and formats to respective manufacturing sites. Ensure timely initiation and closure of change controls, including impact assessments and approvals by relevant departments and Head CQA. Monitor the implementation of established procedures across API manufacturing sites. Provide QA support during regulatory inspections at sites, as needed. Manage document control activities, including issuance, archival, retrieval, and retention of GMP documents. Issue GMP-related registers and reconcile records ac...

Are you passionate about leveraging technology to automate and transform business processes Do you have a deep understanding of test automation and a desire to drive innovation in enterprise systems If so, the Tech@Lilly Enterprise Test Automation team invites you to apply for the role of Test Automation Lead . u00A0 As a Test Automation Lead , you will be responsible for driving the quality and reliability of automation solutions across the enterprise. In this role, you will work closely with Engineers and cross-functional teams throughout the full application lifecycleu2014ensuring that systems are thoroughly tested, resilient, and aligned with business needs from development through to pr...

We are hiring for the role of QA: Key Responsibilities Supplier Qualification & Audits Conduct risk-based onboarding, site assessments, and pre-production audits. Schedule and manage supplier audits (including third-party audits). Ensure compliance with audit procedures and oversee corrective/preventive actions (CAR/CAPA). MQM & Food Safety Compliance Ensure adherence to MQM standards via training, audits, and material risk assessments. Escalate critical non-conformities to relevant stakeholders. Risk & Specification Oversight Assess raw material risks and maintain updated risk profiles. Advise on raw material, finished goods, and packaging specifications for supplier compliance. Metrics & C...

As a Patient Safety Support Manager, your primary responsibility will be to manage the outcomes of various audits related to Pharmacovigilance (GVP) systems and processes. This includes overseeing internal audits, business partner audits, deviation investigations, and providing support for the PV Quality Management System (QMS). Your duties and responsibilities will involve ensuring that corrective and preventative actions are promptly authored and implemented following post-evaluation of GVP audits. You will collaborate effectively with external quality and compliance organizations to uphold high standards of quality within the department. In addition, you will participate in or lead assess...