670 Process Validation Jobs - Page 5

ENURANCE TECHNOLOGY LTD. Position Title: Process Development Engineer Reports to: Plant Head/ Process Development Manager Location: Aurangabad , Maharashtra Team size: 2~3 Direct Repartees. Experience: 8 to 10 Years A process development engineer designs, implements, and optimizes manufacturing processes to improve efficiency, product quality, and cost-effectiveness, ensuring safety and compliance with industry standards Candidate from Brakes or ABS back ground is preferred. Analyses new Product feasibility, cycle times estimation, machines & tools planning, tools/fixtures cost estimation, design & participation in DVP, execution. Designing of tools, gauges and machining fixtures & CNC machi...

Responsibilities: Prepare and review Batch Manufacturing Record & Batch Packaging Record Prepare Stability Process Validation Protocol Hold Time Study SMPC/ Insert Collaborate with cross-functional teams on CAPAs and process improvements.

SHOULD YOU ACCEPT THIS CHALLENGE Pure Storage builds the industry s most innovative, easiest to use, high-performance, and highly available portfolio of products that are designed for the most demanding mission critical applications. While we deliver a hardware storage array, over 90% of our engineering staff are software engineers. Our customers are the most important part of our business and they love FlashArray and FlashBlade for their simplicity of management, the constant flow of new and exciting upgrades, and ability to live on the cutting edge of technology while never taking downtime, ever. Most recently, we extended the value of our capabilities into the cloud with CloudSnap and Clo...

Role & responsibilities 1. Responsible for review of User Requirement Specification, Design Qualification, FAT Protocols, SAT Protocols, Installation Qualification, Operational Qualification, Performance Qualification Protocols and reports. 2. Responsible for preparation of commissioning protocols, FAT, SAT and associated risk and GAP analysis documents. 3. Responsible for preparation of facility, equipment, area qualification protocols, reports and execution. 4. Accountable for ensuring the compliance the qualification activities in -line with global quality/regulatory requirements. 5. Responsible for Engineering compliance and review of Engineering department SOPs, PMP calibration and faci...

Job Title: Deputy Manager- Formulation Location: Govandi, Mumbai Department: Corporate Quality Assurance Qualification, Experience and Technical Competency: 1. Master’s Degree in Pharmacy or Science or equivalent scientific field. 2. Minimum 10 years experience in Pharmaceutical Industry (Strong background of Formulation industry with 2 to 3 years experience in Quality Control.) 3. Work experience in Regulatory Sites (USFDA, MHRA, EU GMP) 4. Knowledge of current Good Manyfacturing Practices (cGMP), Quality Management Systems (QMS) and regulatory guidelines. Key Requirements: Responsible for Quality Functions across Own Sites and Contract Sites with adherance to cGMP, Regulatory standards and...

Senior Manager 1

As a Facility and Equipment Maintenance Engineer, your responsibilities will include: - Procuring engineering consumables, proprietary spares, and maintaining inventory - Performing and approving Qualification studies for equipment and facility - Scheduling and executing preventive maintenance programs for plant and utility equipment - Reviewing and participating in process validation programs - Maintaining and updating drawings like plant layout, equipment layout, and P & ID for equipment and HVAC system - Scheduling and executing Annual Maintenance Programs for utility and material handling equipment - Arranging instruments for plant equipment and accessories - Reviewing, authorizing, and ...

Job Description Summary Position Summary: This position works cross-functionally to lead research and development sustaining projects of complex medical devices. The position implements existing products with to comply with ISO 80369-7 EU MDR requirements, focusing on project planning, innovative medical device design, prototype development, testing characterization, analysis and reporting. Job Description Essential / Key Job Responsibilities (including supervisory and/or fiscal): Design development and implementation. : Designs, develops and implements existing products and processes of a medical device, translating ISO standards into tangible engineering specifications and drawings. ISO 80...

Responsible to review and execution of qualification document related Equipment, Facility and Utility like Plant equipment, HVAC, Water system and Compressed air system. Responsible to review and execution of Re-Qualification document. Responsible to co-ordinate with manufacturing personnel for respective qualification / validation / Re-qualification activity form timely completion of activity. Responsible for preparation, review and execution of risk assessment related tEquipment, System, Facility and Process. Responsible for preparation and review of validation master plan tensure execution of activity. Responsible for preparation of cleaning validation protocol and compilation and review ...

Job Responsibilities: To ensure implementation of cGMP norms in manufacturing areas To give line clearance in dispensing, manufacturing and packaging To monitor dispensing, manufacturing and packaging Sampling of In-process, finished stage and process validation batches and forwarding the same to Quality Control department for analysis To ensure that gowning and entry/ exit procedures are followed as per standard procedures Monitoring of environmental conditions (temperature, humidity & pressure differential) in manufacturing areas To carry out IPQA checks in manufacturing and packaging areas To ensure online documentation To verify that the appropriate qualification, calibration and prevent...

Position - Supervisor Manufacturing & Process Development Engineer - Relay Aerospace Plant) Job Overview Manufacturing engineer is responsible for preparing the process sheets, tool design, establish overall strategic goals & objectives of Manufacturing Engineering in alignment with organizational goals.This role will be an individual contributor, which reports to MGR I MFG & Process development engineer Responsibilities: Analyze new technology and manufacturing processes. Plan and assess the feasibility of new and running projects. Ensure good interfaces between Production, Production Planning, Engineering, QC and other functions. Plan, design, and monitor manufacturing improvement processe...

Job Responsibility JOB DESCRIPTION Responsible to update on self-hygiene. Responsible for preparation, review, revision, control and implementation of standard operating procedures of sterile manufacturing department. Responsible for preparation & review of the master documents of production. Responsible for preparation and review of protocols and reports based on the requirements. Responsible for document management like BMR's, BPR's, master SOP's etc. Responsible for the handling of change control, deviations, CAPA, investigation etc. Responsible for operations like manufacturing, filling & sealing, labeling and packing operations. Responsible for preparation of production planning on mont...

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufactur...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com. Job Summary To Manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging vali...

Design QE methodology and test approaches that validate features developed by Agile / Scrum teams and ensures the accuracy of the requirements Drive, scope, design and code automated tests Create automation best practices Participate in our Agile process by being an active contributor in daily standups, sprint kick-offs, demonstrations, and retrospectives Make recommendations for improvements in how we engineer our products. Perform manual and automated QE processes for new releases, and for routine maintenance. Report defects and testing status Design test environment in QE Lab Simulate real-world deployments of the products, and reproduce customer issues Required education Bachelor's Degre...

Greetings!!! We are seeking for an API - Research & Development Synthesis role for a Pharma Manufacturing Company at Gurgaon, Haryana

Role & responsibilities Feasibility of New Products. PPAP, PFMEA, PFC Process, IATF 16949, VDA 6.3 Responsible to program launch stage till SOP Responsible for facilities, planning to develop SPM, JIG & Fixture, material handling & equipment's. Support to production for problem solving & analysis. Preferred candidate profile Candidate should have worked in stamping and sheet metal industry, with having exposure of sheet metal products.

Job Responsibilities: 1. Drafting, Issuance and archival of BMR, BPR, Process validation Protocols/reports etc. 2. Issuance and retrieval of various documents. 3. In-process check during Dispensing of raw/ packing material. 4. In-process checks for Lozenges, Inhalers, Ointment, etc. 5. Line clearance activity. 6. To ensure timely updating and review of the records like temperature, humidity and pressure differential pressure etc. 7. To be part of validation and qualification team and perform/monitor sampling and data collection as per protocols. 8. To ensure Batch records are online. 9. To ensure the manufacturing and packing activity perform as per batch records. 10. Review batch manufactur...

Responsibilities: To impart the departmental training & co-ordinate for cGMP training as per planned schedule. To Coordination of Regulatory/Customer audit and its compliance. Review the audit feedback and provide the action plan for compliance of audit observation/ findings. To perform self-inspection for all respective departments & evaluate the compliance of any reported non-compliance in the self-inspection report. To review the deviation, change control, incident for impact on product quality and safety in QAMS. Perform risk assessment for risk reduction/mitigation at acceptance label for product & QMS related documents as part of impact assessment. Review of QA documents, review of spe...

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Data Warehouse ETL Testing Good to have skills : NA Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with team members to understand project needs, developing application features, and ensuring that the applications function seamlessly within the existing infrastructure. You will engage in problem-solving discussion...

Job Title: Senior Officer – Process Engineering Business Unit: Engineering Job Grade G12B Location : Gangtok At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Execution of Breakdown maintenance...

As a QA Validation Specialist at Quascenta, you will play a crucial role in providing technical support for software products such as ValDoc Pro, eLog Pro, and QMS Pro. Your responsibilities will include: - Assisting companies with uploading SOPs and managing qualification in the application - Executing qualification scripts (IQ/OQ/PQ) online - Writing and executing test scripts - Opening bug tickets when necessary Qualifications required for this role: - Prior experience in using QMS software - Experience in equipment/instruments qualification - Experience in process validation will be an added advantage - Fluency in Hindi is a mandatory requirement Quascenta is a leader in offering validat...

As a Chemical Process Development Engineer, you will play a crucial role in leading the development and optimization of chemical processes using various flow reactors like microreactors, tubular reactors, and packed-bed reactors. Your responsibilities will include: - Collaborating with synthetic chemists and process engineers to transition batch processes to continuous flow - Developing and validating process parameters such as residence time, flow rates, mixing, pressure, and temperature - Integrating online/inline monitoring tools (PAT) including FTIR, UV-Vis, NMR, and HPLC - Ensuring robust data analysis, modeling, and documentation of experiments and findings Qualifications Required: - B...

Role Overview: As a Lead in this role, you will be responsible for ensuring the timely completion of activities related to process validation of orders and all statutory requirements, budgetary control MIS, and other system-related issues. Your primary focus will be to provide commercial support for seamless functioning by offering inputs on direct tax, indirect tax, finance, legal matters, and tax optimization. Key Responsibilities: - Review and validate purchases orders and contracts from commercial and finance perspectives. - Ensure optimization of taxes and duties through knowledge of both direct and indirect taxation. - Implement tax optimization strategies for Package Items, Constructi...

As a Quality Sr Specialist at Teva Pharmaceuticals, you will play a crucial role in ensuring the quality and compliance of active pharmaceutical ingredients (APIs). With over 80 years of experience in the generic API industry, Teva Pharmaceuticals is a trusted global supplier supporting 80% of the top 50 global pharmaceutical companies. Your contributions will directly impact the timely introduction of new products to the market, solidifying Teva's position as a leader in the industry. Key Responsibilities: - Collect, compile, analyze, and review all data for Annual Product Quality Review (APQR). - Process and oversee changes through the entire workflow, including generation, justification, ...