24 Deviation Handling Jobs

As a Security Officer in our company, your role involves providing security and asset protection for the property, personnel, material, and information within your assigned duty area. You will work alongside a team of company officers and outsourced staff under the supervision of your Manager. Through on-the-job training, you will learn and execute tasks as guided by your managers. - Responsible for access control of men, material, information, and vehicles - Check and ensure access control and property protection in the assigned area - Monitor the validation of incoming/outgoing vehicles, personnel, and material - Keep track of material transitions to and from other areas - Conduct random c...

As a Packing Department Officer, your role involves the following key responsibilities: - Preparation, review, revision, control, and implementation of standard operating procedures for the packing department. - Preparation and review of master documents related to packing. - Preparation and review of protocols and reports as per requirements. - Management and preparation of documents such as BPRs, master SOPs, etc. - Identification of training needs and provision of SOPs and developmental training within the department. - Handling of Change Control, Deviations, CAPA, Investigations, and other related tasks. - Assisting the packing officer in line clearance activities before operations like ...

As a Validation Specialist at our company, your role will involve ensuring that the validation system remains updated according to regulatory requirements and industry standards. You will be responsible for executing and reviewing Qualification/Re-Qualification and Validation activities for Equipment/System/Facility and Plant utilities. Your coordination with manufacturing, Engineering, and QC personnel will be crucial for the timely completion of Qualification/Validation/Re-qualification activities. Additionally, you will be preparing Standard Operating Procedures for the Quality Assurance Department and conducting sampling activities as per protocols such as Process Validation and Cleaning...

As the Head of Quality Assurance & Quality Control in the cosmetics industry, your role is crucial in establishing, implementing, and maintaining quality management systems throughout the manufacturing value chain. You will lead both Quality Assurance (QA) and Quality Control (QC) teams to ensure compliance with regulatory, customer, and company standards for product safety, efficacy, and consistency. **Key Responsibilities:** - Develop, implement, and maintain Quality Management Systems aligned with cosmetic industry standards. - Establish and monitor SOPs for various processes including production, packaging, warehousing, and distribution. - Supervise validation and qualification activitie...

As a part of the Biocon Biologics team, your role will involve preparing and reviewing technical documents, protocols, and reports. You will be responsible for reviewing change control, CAPA, effectiveness checks, and events. In addition, you will handle deviations, CAPA, and coordinate with the QA department. Your involvement in investigating and closing deviations will be crucial, along with managing annual refresher trainings and preparing User Requirement Specifications for new machines. Key Responsibilities: - Preparation and review of technical documents, protocols, and reports - Review of change control, CAPA, effectiveness checks, and events - Handling of deviations, CAPA, and coordi...

As a Production Supervisor, you will be responsible for overseeing the production execution, compliance, supervision, quality control, documentation, GMP compliance, change control, training, manpower management, and deviation handling. Your key responsibilities will include: - Overseeing the execution of production plans using pre-approved procedures, protocols, and manufacturing records. - Ensuring adherence to cGMP and EHS (Environmental, Health, and Safety) norms. - Supervising and coordinating production activities, including managing available resources to achieve production targets. - Maintaining standard process parameters as per Batch Manufacturing Records (BMRs) and other supportin...

As a Quality Control Compliance Reviewer at Amneal, you will be responsible for ensuring cGMP compliance in the QC laboratory. Your key responsibilities include: - Reviewing the completeness of analytical documents and approving the Certificate of Analysis (CoA) for Raw materials, packaging materials, In-process, finished products, stability studies for submission, validation, and commercial batches. - Performing/reviewing investigations for Quality issues such as Out of Specification (OOS), Deviations, Incidents, Corrective and Preventive Actions (CAPAs) related to laboratory. - Ensuring implementation of CAPAs recommended in OOS, Out of Alert Limits (OOAL), Incidents, and deviations in the...

Summary The purpose of the investigation and deviation expert 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 devi...

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