73 Deviation Management Jobs

As a Technical Writer specializing in Change Control Management, your role involves developing, managing, and maintaining documentation related to change control processes within a regulated manufacturing environment. You are responsible for ensuring documentation accuracy, consistency, and compliance with regulatory and organizational standards. Leveraging your knowledge of science and manufacturing technologies, you will collaborate effectively with cross-functional teams, streamline documentation workflows, and support the organization's change control management processes. Key Responsibilities: - Develop, revise, and maintain high-quality documentation related to change control processes...

As an ideal candidate for this role, you should have awareness on CSV and Business process Automation, along with being familiar with digital automation activities. Your key responsibilities will include: - Preparation of Digitalization System documentation as defined under procedure. - Preparation of Supplier / Service Provider Assessments for Digitalization Process. - Preparation of Standard Operating Procedures for the operation and maintenance of the Digitalization System. - Preparation of Impact Assessments, Risk Assessment reports related to Digitalization Process. - Ensuring supplier / vendor related documents with respect to the Digitalization System. - Reviewing the established Digi...

Role Overview: As a Shift Leader at Continental Automotive Components Private Ltd., your main responsibilities include executing Shift Leader routines, coordinating and supporting the Line Leader to achieve internal production KPI targets, identifying systematic failures and initiating problem-solving measures, performing deviation management for safety, quality, productivity, and cost targets, ensuring updated data in the LIB, participating in cross-functional meetings, and triggering support functions or escalation plans when needed to reach targets. You will also manage resources in the shift, prioritize activities to manage workload, monitor constraints, assist in disciplinary measures, ...

You will be responsible for the following key responsibilities: - Deviation Management - Quality System Implementation - Regulatory Compliance - Process Validation - Documentations & Audits You should possess the following qualifications: - M.Sc. in Chemistry Please note that the work location is in person and the job type is full-time, permanent. Additionally, the benefits include Provident Fund, and the schedule is day shift.,

You will be joining Biocon Biologics, a subsidiary of Biocon Ltd, a global biopharmaceuticals company dedicated to developing high-quality, affordable biosimilars to provide advanced therapies to patients worldwide. As a QMS Compliance Team Member, you will play a crucial role in ensuring manufacturing compliance for biosimilars in the following key responsibilities: **Role 1 Manufacturing Compliance (Biosimilars Compliance):** - Investigate microbial excursions for facility, utility, and process. - Prepare contamination control and strategy documents. - Conduct product quality assessments for microbial contaminations. - Develop risk assessment protocols and reports. - Harmonize procedures a...

About the Role: We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems impacting regulated data or processes are validated and maintained in accordance with applicable industry and regulatory standards. Key Responsibilities: Lead and execute Computer System Validation (CSV) activities across various GxP-regulated systems and applications. Ensure all software, cloud platforms, and supporting infrastructure comply wi...

Summary The purpose of the investigation and deviation Specialist role is to work collaboratively with process experts and multifunctional operations teams in Radio Ligand Therapy (RLT) platform sites, taking ownership of deviation management for the site. The individual will actively participate in investigations of deviations, complaints, and OOXs by interacting with Cross-Functional Teams (CFT) and implementing Corrective and Preventive Actions (CAPA), Effectiveness Checks (EC), risk assessments, and quality management. The role will play a key part in facilitating effective communication between teams and supporting problem-solving activities. About The Role Key Responsibilities: Manage ...

As a Process and Customer Quality professional (QMPP) at Schaeffler India Ltd (formerly Vitesco Technologies) in Pune, Talegaon Plant, your role is crucial in ensuring that products meet internal specifications and customer expectations. You will lead continuous improvement efforts, manage quality systems, and collaborate with various departments to enhance product and process quality. **Key Responsibilities:** - Lead systematic problem solving for internal process rejections using standards and systems. - Define and implement a roadmap to achieve Quality KPIs for processes. - Resolve top issues using a structured approach to prevent recurrence. - Plan and execute manufacturing quality audit...

Role Overview: At Elanco, you will be the Manufacturing Science & Technology (MS&T) Manager for API, playing a crucial role in ensuring reliable, compliant, and cost-effective API manufacturing. You will collaborate with various departments to support established products, drive process improvements, and facilitate regulatory submissions. Your expertise will be instrumental in enhancing animal health and advancing the company's mission of Food and Companionship Enriching Life. Key Responsibilities: - Serve as the primary technical resource for assigned API manufacturing processes, offering on-site support as required. - Lead technology transfer, process implementation, validation, and improv...

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

As a Biopharmaceutical Manufacturing Specialist, you will be responsible for hands-on execution of manufacturing processes in both upstream and downstream operations. This includes working with single-use bioreactors, media preparation systems, AKTA systems, chromatography columns, UF/DF systems, buffer preparation units, virus filtration, and other single-use technologies. Your main focus will be to ensure batch operations are conducted in compliance with cGMP guidelines, maintaining strict adherence to quality standards and regulatory requirements. Key Responsibilities: - Conduct batch operations in compliance with cGMP guidelines - Maintain and support Quality Management Systems activitie...

As a candidate for this role, you will be responsible for various tasks related to self-hygiene and the sterile manufacturing department. Your key responsibilities will include: - Updating on self-hygiene - Preparation, review, revision, control, and implementation of standard operating procedures - Preparation and review of protocols and reports - Document management including BMRs, BPRs, Master SOPs, etc. - Handling of Change Control, Deviations, CAPA, Investigation - Generating general purchase indents for departmental items - Preparation of production planning on a monthly and daily basis - Preparation of daily production reports - Ensuring validation and calibration status of equipment ...

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.,

As a Document Controller at Ferring India Laboratories, your role involves handling the issuance, control, and retrieval of documents. You will be responsible for scanning and uploading approved paper-based documents in Veeva Vault. Additionally, maintaining master copies for SOPs, including issuance, control, and retrieval of SOPs will be a key part of your responsibilities. Your key responsibilities will include: - Managing and conducting training sessions - Organizing training programs - Maintaining vendor audit and technical agreement planners - Preparing and reviewing SOPs, Protocols, and other cGMP documents - Tracking Change control, CAPA, Deviation, OOS/OOT, and coordinating with sta...

As a Site Quality Head at our reputed pharmaceutical manufacturing company in Vapi, Gujarat, you will be responsible for leading and overseeing the Quality Assurance and Quality Control functions at our Oral Solid Dosage (OSD) facility. Your role will involve full ownership of quality systems, lab operations, regulatory compliance, and audit readiness. To excel in this position, you should currently hold a site-level quality head role and have hands-on experience managing QA and QC teams in a regulated pharmaceutical environment. **Key Responsibilities:** - Lead and manage the complete Quality function (QA and QC) at the site - Ensure compliance with GMP, regulatory, and customer requirement...

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 ...

In this role at Piramal Agastya, your primary responsibility is to ensure compliance with regulatory and Pharmacopoeial standards through compendia assessments, Quality Management System (QMS) oversight, and documentation preparation. You will collaborate with global sites, vendors, and internal teams to develop quality agreements and provide support during audits and inspections. Additionally, you will be managing SOPs, monitoring QMS events, and preparing essential quality documentation and reports. As part of your responsibilities, you will: - Conduct compendia assessments for all materials used on-site to identify gaps against current Pharmacopoeial requirements and implement risk mitiga...

As an Analytical Scientist C at BacAlt, you will play a crucial role in the Research and Development Department. Your primary responsibility will be to develop and validate analytical methods for various instruments such as HPLC, GC, GC-MS, IR, UV-Visible Spectroscopy, Particle Size Analyser, and more. Additionally, you will be responsible for conducting wet analysis in the lab, planning stability studies, and performing testing according to established protocols for formulations, APIs, and excipients. Key Responsibilities: - Develop and validate analytical methods for various instruments including HPLC, GC, GC-MS, IR, UV-Visible Spectroscopy, and more. - Conduct wet analysis in the lab and ...

To set, attain and preserve the user requirements' information and the quality of project documentation, throughout the complete project lifecycle, cooperating in particular with Sales, Project Managers and Validation. Main responsibilities : - 1. URS - Assist the Sales Back Office to register the User Requirement Specifications (URS) for the subsequent dispatch of the specific documents to the relevant department. 2. Documents requirements - Assist the Sales Team as main reference person for the documentation strategy during the offer phase (URS analysis / Documents proposals) 3. Deviation to requirements - Assist the Sales Team to record the list of deviations from the customer's URS. 4. D...

Role Overview: You will be joining Syngene International Ltd. as a Senior Executive 9-II in the Quality Assurance department at the Mangaluru location. Your main responsibility will be to provide in-process Quality Assurance support for executing GMP manufacturing activities at the Mangalore manufacturing facilities. You will ensure that the Site Quality system is always in compliance and ready for Regulatory & Client inspections by following all necessary quality procedures. Additionally, you will handle change controls, deviations, CAPAs, and assure online documentation integrity. Key Responsibilities: - Provide In-process Quality Assurance support for GMP manufacturing activities - Ensure...

As a Material Management Specialist, your role involves planning and controlling inventories of raw materials and packaging materials to meet production requirements. You will coordinate with Purchase and Quality Control teams to ensure timely availability and release of materials. Additionally, you will oversee the receipt, storage, and dispensing of materials in compliance with SOPs, MSDS, and safety requirements. It will be your responsibility to manage the return, rejection, and destruction of non-conforming materials following established procedures. Your key responsibilities include: - Planning and controlling inventories of raw materials and packaging materials - Coordinating with Pur...

Job Purpose We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations. Roles & Key Responsibilities Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.). Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of pro...

Job Purpose We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations. Roles & Key Responsibilities Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.). Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of pro...

Oversee QA For Contract Manufacturing: Draft Agreements, Review Batch Docs, CoAs, Deviations, And Artwork. Ensure GMP Compliance, Traceability, And Regulatory Alignment. Support IPQA Checks, Sampling, Audits, And Real-Time Issue Resolution. Required Candidate profile Skilled in corporate QA documentation, third-party coordination, and artwork review Manage change control, audit readiness, and traceability Ensure regulatory compliance and product release approval

Key Responsibilities Lead, manage, and develop the QC function for pharma formulations as per company policies and regulatory requirements. Supervise and resolve lab incidents, deviations, change controls, OOS/OOT , and ensure robust documentation and root cause analysis. Oversee process validation, cleaning validation, hold time studies and related compliance activities. Establish and implement Stability Study protocols as per company SOPs, client specification, and all applicable quality standards. Handle product complaints & recall investigations in collaboration with QA and Production teams. Ensure compliance with current GMP, GLP, and regulatory guidelines for all laboratory operations....