1753 Change Control Jobs - Page 40

Role & responsibilities Handling the Change Control Programme and functional Change Control Coordinator. Handling of Deviation and Market Compliant. Preparation and review of Annual Product Quality Review. Preparation, maintenance, reviews of all other QMS documentation. Handling of RM/PM rejection documents. Preparation and issuance of SOP's. Preparation, Review and Execution of Process Validation Protocol and Report. To Collect and send sample to QC for analysis. To release the product for next stage after receiving QC release report. To maintain logbook and document control. Issuance of format. Reviewing of BMR / BPR. Ensure the implementation and compliance with cGMP aspects. Ensure comp...

Responsible for QA functions-legal documentation, Compliance of QA/ISO/EHS systems/insecticides rules, Analysis, Timely, accurate & cost effective analytical support to plant, preparing SOP/Verification of testing methods, Instruments calibration etc Required Candidate profile M.Sc.with 3 to 6 yrs relevant exp in Agrochemical industry. Knowledge of quality systems, in house calibration of lab instruments , handling of QA lab Instruments , Root Cause Analysis Techniques etc.

Roles and Responsibilities Conduct quality reviews of documents, including CAPAs, change controls, and 21 CFR compliance. Ensure adherence to company policies and procedures through document review. Develop and maintain a thorough understanding of regulatory requirements for pharmaceuticals. Provide feedback on document quality and suggest improvements where necessary. Collaborate with cross-functional teams to resolve issues related to document control.

Ensure compliance with GMP & regulatory standards, oversee quality systems, audits & validations, manage QA team, review batch records, handle deviations/CAPA, support regulatory inspections, ensure product quality & safety across manufacturing.

As a member of the Consulting organization, you are responsible for ensuring that a quality, integrated software solution is delivered in a timely manner, at budget, and to our client's satisfaction. This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery. Responsibilities Experienced in managing large-scale and complex Oracle Cloud implementation and transformation projects from initiation to completion. Create and lead comprehensive project plans covering budget, structure, scheduling, staffing models, and resourcing while ensuring alignment with Oracles compliance, security...

Project Planning Scheduling: Develop detailed project plans and schedules using Microsoft Project (MSP) . Monitor and update the master construction schedule, ensuring it aligns with agreements made with contractors. Develop schedules at both macro and micro levels, categorizing tasks into overall programs, tender schedules, and individual work categories. Manage sequencing of activities, ensuring that timelines and project phases are met according to the plan. Project Governance Coordination: Establish effective project governance, processes, and systems to ensure smooth execution. Manage the change control process to ensure adherence to project scope and minimize scope creep. Ensure consis...

Project Planning Scheduling: Develop detailed project plans and schedules using Microsoft Project (MSP) . Monitor and update the master construction schedule, ensuring it aligns with agreements made with contractors. Develop schedules at both macro and micro levels, categorizing tasks into overall programs, tender schedules, and individual work categories. Manage sequencing of activities, ensuring that timelines and project phases are met according to the plan. Project Governance Coordination: Establish effective project governance, processes, and systems to ensure smooth execution. Manage the change control process to ensure adherence to project scope and minimize scope creep. Ensure consis...

As a Qualified Person (QP) at PCI, you will play a crucial role in certifying investigational medicinal products in compliance with the requirements of the Investigational Medicinal Product Dossier (IMPD) and Product Specification File (PSF). Your responsibilities include ensuring the compliance of all batches to EU Directives, Annex 16, and Detailed Commission Guidelines related to Investigational Medicinal Products (IMPs). You will provide direct support and guidance to the Quality management team to ensure that Quality operations meet the necessary site safety, quality, and cGMP requirements. Additionally, you will participate in cross-functional teams to offer consultative support on qua...

We are seeking a skilled SAP Project Manager proficient in S/4 HANA and ECC, with a strong focus on leadership. By joining our Technology Consulting team, you will assist companies in addressing a variety of tasks, from meeting market demands to implementing cost reductions and ERP systems. As a member of our expanding team, you will contribute to shaping the innovative culture that defines AG as a great place to work. If you possess a strong interest in technology, along with intellectual curiosity and energy, Technology Consulting may be the ideal environment for you. Key Responsibilities: - As a high-achieving Project Manager, you will support our growing business, specifically in our exp...

As a member of Pfizer's quality assurance team, you will play a crucial role in ensuring the delivery of safe and effective products to patients. Your commitment to quality, compliance, and patient-centric approach will directly impact the lives of those who rely on our products. Your responsibilities will include evaluating and reviewing clinical and commercial drug batches to ensure they meet established specifications. You will conduct rigorous sampling and statistical process control procedures to identify deviations from standards and approve investigations and change control activities to maintain compliance with configuration management policies. In this role, you will contribute to m...

You will be responsible for preparing and reviewing the master documents of sterile manufacturing for the parenteral facility. Additionally, you will prepare and review protocols and reports based on the specified requirements. Document management and preparation tasks such as BMRs, BPRs, and master SOPs will also fall under your responsibilities. Handling change control, deviations, CAPA, investigations, and providing training to subordinates, technicians, and operators within the department are key aspects of this role. You will also be accountable for audit and compliance on the manufacturing shop floor. The ideal candidate for this position should hold a B.Pharm/M.Pharm degree and posses...

As a PMO Project Manager, you will be responsible for delivering consistent project governance, supporting commercial and planning aspects of project delivery, and ensuring alignment with strategic objectives across a portfolio of infrastructure and property projects. You will work closely with technical delivery teams, clients, and internal stakeholders to ensure successful project outcomes. In this role, your key responsibilities will include leading and supporting project planning, controls, and reporting in line with BMS and PMO frameworks. You will be tasked with ensuring project compliance with governance standards and contractual obligations, as well as maintaining project reporting c...

As a JAVA Developer with 3-5 years of experience, you will be responsible for utilizing your expertise in JavaScript, MySQL, and Database Architecture design. Your role will involve working with REST, SOAP, and Postman to enhance system functionalities. A2S certificate management will be a key aspect of your responsibilities. Your qualifications should include a B.E, B.Tech, M.E, M.Tech, or M.C.A degree. The position is based in Chennai. Additionally, you should possess good knowledge of software deployment, software versioning, and change control processes. If you are looking for a challenging opportunity to showcase your JAVA development skills and contribute to software projects, this rol...

NTT DATA is looking for an Access Services General to join the team in Hyderabad, Telangana (IN-TG), India (IN). As an Access Services General, you will be utilizing your technical and operational expertise to support and provide recommendations for delivering effective IT services that meet the day-to-day needs of the business. Your key accountabilities will include consulting and recommending necessary actions for the operational delivery of core IT Services to all business partners within your area of responsibility, such as infrastructure, network, workplace, application, and security. You will be required to utilize technology and collaborative skills to provide design expertise for the...

Roles Responsibilities: Partner with IS and Business collaborators to understand how automation can improve workflow and efficiency; ensuring solutions meet business needs. Lead the day-to-day operations and maintenance of Pharmacovigilance systems (safety database). Find other opportunities for automation and process improvements within the Safety ecosystem. Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process. Part of project/product team, willing to jump in and do programming/code-reviews etc based on demands. Hands on programming (SQL/Scripts) is exp...

The Application Engineer plays a crucial role in customer service, providing engineering support to meet the evolving needs of customers. As the primary point of contact for technical program matters, you will be frequently onsite with customers. Your responsibilities include establishing and nurturing effective customer relationships, serving as a liaison between customers and Visteon's Product Development (PD) and Manufacturing teams. You will be tasked with coordinating customer feedback with manufacturing and PD teams, assisting customers with Visteon products, and ensuring customer satisfaction in line with Visteon policies by addressing issues and roadblocks. It is essential to identif...

We are seeking skilled and dedicated individuals to join our Quality Assurance (QA) department at Fido Pharma Private Limited, an esteemed pharmaceutical company located at Plot No: 108-109, Global Industrial Park, Mauli, Barwala, Panchkula, Haryana. If you have a background in B.Pharm / M.Pharm / M.Sc. and a passion for ensuring quality in pharmaceutical products, we have the following positions available: QA Manager: As a QA Manager, you will lead our Quality Assurance department, overseeing adherence to GMP and regulatory guidelines such as EU-GMP and WHO-GMP. Your responsibilities will include managing document control, validations, change control, Vendor Qualification, CAPA, deviations,...

You should have a strong knowledge of QMS /cGMP Documentation related to engineering. Additionally, you must be familiar with calibration of instruments related to Temperature, pressure, Level, flow, and weight. Basic knowledge on PLC, SCADA, and its operation is required for this role. It is important to understand breakdown and prepare breakdown analysis data. You should also be knowledgeable about P&ID diagrams and hook up diagrams, as well as all types of on-off valves and control valves. Handling of projects, contractors for Addition and Alteration of Equipments/Building facilities, and high voltage substation, Generators & Instrument control system is part of the responsibilities. You ...

The Senior QA Executive plays a crucial role in overseeing various aspects of quality management within the organization. This includes but is not limited to document control, compliance monitoring, internal audits, quality metrics tracking, and non-conformance management. The position also involves contributing to change control, supplier evaluation, risk management, product and process validation, complaint handling, CAPA support, and quality improvement projects. A key part of the role is to engage in data entry, analysis, and report preparation to ensure alignment with quality and compliance objectives. Responsibilities of the role include: - Document Control: Assisting in the organizati...

Join a forward-thinking engineering team in Pune where your technical expertise and attention to detail will directly contribute to the development and delivery of high-quality products. This role offers the opportunity to work with cross-functional teams, enhance your SAP and CAD skills, and play a key role in driving data accuracy and process efficiency. You are a proactive and detail-oriented engineering professional with a strong foundation in mechanical design and a solid grasp of SAP systems. You enjoy solving problems, managing data, and collaborating across departments to ensure smooth product development and order fulfillment. Minimum Qualifications - Bachelors Degree in Engineering...

We are looking for a candidate to oversee manufacturing and production operations, managing equipment, process validation, handling change controls, deviations, incidents, and ensuring compliance with regulatory audits. Responsibilities include creating SOPs (Standard Operating Procedure), providing training, and applying expertise. Roles & Responsibilities You will be responsible for handling line operations, specifically production and manufacturing activities like CIP (Cleaning-in-place), SIP (Sterilizing-in-place), and batch manufacturing. You will be responsible for handling equipment like Steam Sterilizer, Dry heat sterilizer, HVAC (Heating, Ventilation, and Air Conditioning), water sy...

As a Quantity Surveyor at Worley, you will be an integral part of our team, collaborating to deliver projects for our clients while honing your skills and experience. With a focus on contract management expertise, you will be responsible for various activities related to contracting, procurement, and supply chain management in alignment with the Project Execution Plan (PEP). Your role will involve managing the entire procurement process for engineering construction works, from pre-award to post-award stages. Your primary duties will include providing contract management and quantity surveying expertise for assigned projects. In the pre-contract phase, you will handle activities such as prepa...

You will be working in the Store & Warehouse department as an Assistant Manager, reporting to the Department Head. Your main responsibilities will include dispensing raw materials according to standard operating procedures, ensuring compliance with cGMP regulations, and maintaining cleanliness and sanitation in the raw material dispensing area. You will be required to perform daily verification of weighing balances, record temperature and humidity levels, and ensure the proper cleaning and operation of equipment such as vacuum cleaners and barcode scanners. Additionally, you will be responsible for calibration of balances, segregation of dispensed materials for different batches, and issuing...

You are a proactive and experienced Project Lead/Senior Project Lead with a solid foundation in software development and deep exposure to the insurance domain. You should have a strong grasp of Agile project management methodologies, excellent stakeholder management skills, and a passion for delivering high-quality software solutions. You will lead and manage end-to-end software development projects in the insurance domain, facilitating Agile/Scrum processes, driving project planning and execution, managing scope changes, risks, and dependencies, and coordinating with cross-functional teams. Additionally, you will ensure quality assurance, serve as the primary client contact, utilize project...

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...