16 Deviation Handling Jobs

As a qualified candidate for the position, your role overview will involve being responsible for various tasks in the sterile manufacturing department. Some of your key responsibilities will include: - Updating on self-hygiene - Preparing, reviewing, revising, controlling, and implementing standard operating procedures - Reviewing master documents of production - Preparing and reviewing protocols and reports as required - Managing documentations such as BMRs, BPRs, and master SOPs - Handling change control, deviations, CAPA, investigations, etc. - Overseeing manufacturing, filling & sealing, labeling, and packing operations - Creating production planning on a monthly and daily basis - Genera...

As a Senior Officer in Manufacturing at our company, you will play a crucial role in our Manufacturing team, focusing on executing complex production activities, providing technical guidance, ensuring compliance, and supporting the team lead in achieving production goals. Your strong foundation in pharmaceutical unit operations and problem-solving skills will be key in maintaining quality systems. **Key Responsibilities:** - Lead and execute manufacturing processes efficiently including Granulation, Compression, Coating, Filling, Lyophilization, Packaging. - Provide on-floor guidance, supervision, and training to officers & operators. - Review and verify GMP documentation such as BMR, Logboo...

Role Overview: As a member of the ANKLESHWAR QA department, your primary responsibility will involve handling various aspects of quality assurance and investigations related to deviations, out-of-specifications (OOS), out-of-trend (OOT), market complaints, lab incidents, and corrective and preventive actions (CAPA). You will also be actively involved in audits, compliance activities, and leading investigations by forming cross-functional teams (CFTs) to identify root causes and ensure timely completion of investigations. Key Responsibilities: - Handle deviations, OOS, OOT, market complaints, lab incidents, and CAPA effectively. - Conduct audits and ensure compliance with quality standards. -...

As a Vendor Quality Assurance Specialist, your role is crucial in ensuring that all vendors supplying materials meet the company's quality standards and regulatory requirements through a structured vendor qualification and evaluation process. Key Responsibilities: - Initiate and coordinate vendor qualification activities for both new and existing vendors. - Prepare and maintain vendor qualification dossiers and files to ensure documentation accuracy. - Coordinate with procurement and other departments to gather necessary vendor data and documentation efficiently. - Ensure vendors comply with Good Manufacturing Practices (GMP), regulatory requirements, and company quality standards to uphold ...

Role Overview: As a Team Member in IPQA for Injectables/OSD, you will be a skilled professional with over 5 years of experience in real-time monitoring of manufacturing and packaging processes. Your responsibilities will include line clearance, in-process checks, and reviewing Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) to ensure compliance with GMP and regulatory standards. You will also be involved in deviation handling, documentation, and providing audit support for injectable and oral solid dosage forms. Key Responsibilities: - Real-time monitoring of manufacturing and packaging processes - Conducting line clearance and in-process checks - Reviewing Batch Manufactur...

As a Masters graduate from 2024 to 2025 in the locations of Walajabad, Sunguvarchathram, Sriperumbudhur, Kanchipuram, you will be responsible for the following: - **Testing and Analysis:** - Perform analytical testing on raw materials, in-process samples, and finished products using techniques such as HPLC, UV, pH Meter, and etc. - **Documentation:** - Accurately document test results and observations following Good Documentation Practices (GDP) for audit readiness. - Prepare specifications for raw materials, packing materials, finished products, intermediates, solvents, and reagents used in analyses. - Inspect, sample, and test starting materials, packaging materials, semifinished, and fini...

As a Production Planning & Execution specialist, you will be responsible for executing daily production activities on the shop floor according to the approved production schedule. Your role will involve planning and allocating manpower shifts, distributing work effectively with proper supervision, and monitoring utilities to meet production schedules and ensure continuous functionality. Your coordination with various departments will be crucial for the smooth operation of production activities. You will liaise with Warehouse/Stores/Procurement to ensure timely availability of raw materials, coordinate with the QC Department for timely analysis and approval of samples, and work closely with t...

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...

As a Pharma Subject Matter Expert (SME) Trainer, you will be responsible for training candidates in various aspects of Quality Control (QC), Cell Culture Techniques, and Laboratory Procedures. Your role involves providing hands-on experience in analytical testing, microbiological testing, and pharmaceutical laboratory operations. It is essential to educate candidates on method validation, stability testing, and data integrity while ensuring compliance with FDA, USP, and cGMP regulations. Additionally, you will train individuals in utilizing HPLC, GC, UV-Vis, FTIR, PCR, ELISA, and Spectroscopy techniques. Your responsibilities include conducting mock interviews, assisting with resume preparat...

The ideal candidate will be responsible for overseeing the execution of production plans by utilizing pre-approved procedures, protocols, and manufacturing records. You will need to ensure strict adherence to cGMP and EHS (Environmental, Health, and Safety) norms to maintain compliance. Additionally, you will supervise and coordinate production activities, managing available resources effectively to meet production targets. Maintaining quality control is a key aspect of this role, where you will be required to uphold standard process parameters following Batch Manufacturing Records (BMRs) and other relevant documents to ensure high-quality production and compliance. Furthermore, you will be ...

Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical activities in Quality control laborato...

As an HVAC & Portable Water System Technician, you will be responsible for ensuring the healthy operation of HVAC equipment with minimal breakdowns. This includes conducting maintenance operations and troubleshooting of electrical panels, as well as managing the portable water system throughout the entire plant. You will also be required to validate the HVAC system regularly to ensure the healthiness of the AHU system. Additionally, you will be responsible for in-house installation work related to the HVAC system, maintaining log keeping in compliance with QMS standards, executing breakdowns, maintenance, and troubleshooting of the HVAC system, and managing inventory control to prevent equip...

The responsibilities for this role include reviewing raw and finished product specifications, ensuring good laboratory practices in the Quality Control department, reviewing audit trial records, analyzing analytical records, reviewing instrument calibration and equipment qualification documents related to QC, validating analytical methods, verifying samples, handling reserve sample room, ensuring analyst qualification, reviewing working standards, managing deviations, change control, OOT, OOS, laboratory incidents, investigations, and annual trends, coordinating CAPA implementation verification and closure, reviewing instrument and equipment preventive maintenance, monitoring and recording t...

As a bench scientist in our organization, you will be responsible for conducting experimentation and research in the area of formulation development, process development, regulatory affairs, and intellectual property for global markets. Your work will involve planning and executing experiments aligned with project milestones while applying scientific principles such as Quality by Design (QbD), Design of Experiments (DoE), statistics, and scale-up principles. You will be expected to analyze and interpret data from literature reviews effectively to support decision-making processes. Additionally, you will need to understand the intellectual property landscape, develop strategies, search for pr...

Perform inspections on products, components and materials to ensure they meet specified quality standards and customer requirements (Incoming Quality , in process Quality & Final Inspection). Monitoring of Product and Process related documents and Improvements activities. Basic Prepare document for customer and supplier regarding Quality system audit. Customer Complaint Handling, Rework and Rejection, in process Rejection Control. Ensure Collection, Monitoring & highlight (Corrective Action preventive action (CAPA),Customer Compliant, deviation handling etc. Communicate quality concerns and findings to relevant to production managers, engineers. Participate in continuous improvement initiati...

Manage QA documents and records Handle deviations, changes, CAPA, complaints Conduct audits and supplier evaluations Monitor quality metrics and improvements Train staff and ensure ISO compliance