15 Capa Management Jobs

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...

Jubilant Pharmova Limited is a company with a global presence that operates in various sectors such as Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics, and Proprietary Novel Drugs businesses. The company is dedicated to providing high-quality products and services in the pharmaceutical industry. We are currently looking for a Deputy Manager-Quality Assurance - Vendor Management & Risk assessment to join our team at Nanjangud, Mysore. In this role, you will be responsible for ensuring compliance with regulatory guidelines and Standard Operating Procedures through vendor audits and quality assurance ac...

Detailed Job Role Oversee quality systems, conduct audits, approve batches, implement SOPs and CAPAs to maintain pharma quality standards. KRA (Key Responsibility Areas) Audits, batch reviews, SOP updates, CAPA management, GMP compliance KPI (Key Performance Indicators) Deviation closure rate, audit pass, CAPA closure time, complaint frequency Job Summary: We are seeking a diligent Quality Assurance Officer to oversee quality systems, conduct audits, approve batches, and ensure compliance with GMP standards. The ideal candidate will implement and maintain SOPs, manage CAPAs, and drive continuous improvement in pharmaceutical quality management. Key Responsibilities: Oversee and maintain the ...

Date: 21 Jun 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Development Services Job Description Job Title: Lead Manufacturing Operations -OSD Job Location: Biocon Park, Bengaluru Department: Drug Product Manufacturing About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in lett...

The Quality Lead position at ProPharma involves driving positive change and process improvement in the assigned region. This role serves as an independent and objective entity, supporting various operational teams and performing quality activities as per ProPharma Group's Quality Policy and procedures. The Quality Lead is responsible for Audit Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities. Developing, managing, and executing quality management processes to ensure compliance with regulatory requirements is a key aspect of this role. Essential Functions: - Maintaining awareness of and ensuring adherence to applicable SOPs/controlled...

As a Senior Executive/ Assistant Manager in the Corporate Quality Assurance Pharmacovigilance department, located in Kandivali - West, Mumbai, your primary responsibility will be to ensure compliance with SOPs of the Corporate Pharmacovigilance cell and Corporate Quality Assurance. You will be expected to assist the Corporate pharmacovigilance cell in overseeing vendor compliance through periodic reviews and vendor audits. In this role, you will act as a liaison with internal and external auditors, taking responsibility for ensuring corrective actions are implemented according to their specifications. Your duties will also include persuading Corporate pharmacovigilance cell staff to adopt an...

The Manager-II in the MSTG department at Dadra is responsible for providing support in the execution and monitoring of trial, scale up, and exhibit process qualification batches. This includes preparing and reviewing new product documents such as material requirement sheets, master formula cards, bill of materials, risk assessment reports, sampling protocols, reports, exhibit batch manufacturing records, and exhibit protocols. Additionally, the role involves sharing process knowledge with cross-functional departments through presentations to facilitate smooth technology transfer. The Manager-II will also be involved in reviewing and evaluating product history and process parameters for techn...

As a Quality Operations Support at Sandoz, your major accountability is to adhere to the current GxP and compliance requirements while delivering quality operations to ensure product quality compliance and regulatory workflows. You will be responsible for ensuring compliance to Sandoz quality standards, relevant regulatory requirements, filed product quality standards, and service level agreements. Additionally, you will support the implementation of service quality and process improvement projects, as well as CAPA management within GQSI. It is crucial to comply with internal functional requirements, including KPI reporting, ticket management tools, and other internal procedures and processe...

We are looking for a meticulous and experienced Technology Transfer Manager to spearhead the efficient transfer of technology for solid dosage forms at Evertogen Life Sciences . This pivotal role involves overseeing the seamless transition of OSD products from R&D or third-party development to our manufacturing plant, ensuring successful scale-up, unwavering regulatory compliance, and adherence to the highest quality standards. The ideal candidate will champion the preparation and review of critical technical documents, including technology transfer protocols, BMR/BPR, and process validation reports, while actively coordinating with cross-functional teams such as QA, QC, RA, and Production. ...

Job Description Summary We are looking for a detail-oriented and compliance-focused QA and Compliance Executive to join our Commercials Department in Mumbai . This role is vital to ensuring that all pharmacovigilance (PV) processes, data documentation, and reporting meet global regulatory standards and internal quality benchmarks. You will play a central role in managing safety data, identifying adverse events, ensuring timely and accurate reporting, and supporting inspection readiness through audits and continuous process improvement. The ideal candidate will have strong knowledge of healthcare regulations such as EMA, FDA, HIPAA, and Good Pharmacovigilance Practices (GVP), along with hands...