223 Equipment Qualification Jobs - Page 4

About Company Founded in 2011, ReNew, is one of the largest renewable energy companies globally, with a leadership position in India. Listed on Nasdaq under the ticker RNW, ReNew develops, builds, owns, and operates utility-scale wind energy projects, utility-scale solar energy projects, utility-scale firm power projects, and distributed solar energy projects. In addition to being a major independent power producer in India, ReNew is evolving to become an end-to-end decarbonization partner providing solutions in a just and inclusive manner in the areas of clean energy, green hydrogen, value-added energy offerings through digitalisation, storage, and carbon markets that increasingly are integ...

As a Deputy Manager at Syngene International Ltd., your main responsibility will be handling QMS documentations like CC, CAPA, and Investigations, as well as managing EDMS documents, study protocols, and qualification protocols. You will be in charge of performing activities related to Engineering & maintenance at Biologics Unit 03 while ensuring GMP compliance and error-free operations. It will be crucial for you to follow all EHS requirements at the workplace to ensure individual and plant safety. - Complete all assigned mandatory trainings related to data integrity, health, and safety measures on time - Ensure compliance to quality systems and current good manufacturing practices - Develo...

Job Description: Ensure GMP compliance. Issue formats & protocols for Process Validation and Hold Time Study. Prepare protocols and reports for Process Validation & Hold Time Study; compile related data. Maintain all process validation documents along with batch records. Perform Process Validation activities on the shop floor. Maintain qualification records as per requirements. Execute equipment software and system qualification & re-qualification activities under supervision and coordination with concerned departments. Prepare QA SOPs. Ensure discipline within the department. Handle incidents, deviations, change controls, and CAPA. Prepare, review, and approve Cleaning Validation Matrix. Pr...

As a Computer System Validation & QA-IT professional, your role involves various responsibilities related to process activities. Some of the key responsibilities include: - Reviewing Qualification and Re-Qualification protocols & reports. - Reviewing Preventive Maintenance & Calibration records. - Reviewing and approving critical consumable items. - Monitoring engineering & utility services such as facility layouts, building layout, material flow, HVACs, Nitrogen plant generation and distribution, purified water generation and distribution, and Equipment qualification. - Reviewing breakdown maintenance system. - Handling SAP activities for Engineering. - Managing new product introduction at ...

Roles and Responsibilities Execute equipment qualification, validation, cleaning validation, vendor qualification activities according to SOPs and regulatory requirements. Conduct process validation protocols, reports preparation, and review of documents. Ensure compliance with cGMP guidelines during execution of QA activities. Collaborate with cross-functional teams to resolve issues related to QA operations. Maintain accurate records of all QA activities and documentation.

Shop floor experience is required in the Tablets and Capsules section and sound knowledge of solid oral equipment functioning and operating principle Perform real-time monitoring of manufacturing and packaging processes to ensure adherence to GMP, SOPs, and regulatory requirements. Conduct in-process checks for critical quality attributes (e.g., weight, hardness, uniformity, and packaging integrity) at defined stages of production. Ensure timely documentation and approval of batch manufacturing records (BMR) and batch packaging records (BPR). Lead and coordinate qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification ...

Roles & Responsibilities Team Management: Lead and manage the in-house team, ensuring smooth day-to-day operations at the site. Allocate tasks and resources effectively to meet operational goals and deadlines. Provide guidance, mentorship, and performance feedback to team members. Operations Oversight: Ensure the site's operations are running efficiently, adhering to company policies and industry standards. Oversee scheduling, logistics, and resource management to maintain productivity. Client/Stakeholder Coordination: Act as the primary point of contact between internal teams and clients, ensuring clear communication and timely updates. Coordinate with other departments to address operation...

1. To perform routine, preventive and breakdown maintenance of plant and Utility equipment. 2. Troubleshooting and maintaining healthiness of plant and Utility equipment. 3. Assisting engineer in modification and improvement activities. 4. Involvement during equipment qualification/validation related activities. 5. Adhere to all company policies & manuals. 6. Strictly adhere to all regulatory and legal compliance. 7. Follow GEP, GMP and GDP during maintenance and project activities. 8. Ensure safety compliance during maintenance of equipment. 9. To maintain equipment cleaning after completion of maintenance activity. 10. To carry out any job assigned by immediate supervisor / HOD.

1. To perform routine, preventive and breakdown maintenance of plant and Utility equipment. 2. Troubleshooting and maintaining healthiness of plant and Utility equipment. 3. Assisting engineer in modification and improvement activities. 4. Involvement during equipment qualification/validation related activities. 5. Adhere to all company policies & manuals. 6. Strictly adhere to all regulatory and legal compliance. 7. Follow GEP, GMP and GDP during maintenance and project activities. 8. Ensure safety compliance during maintenance of equipment. 9. To maintain equipment cleaning after completion of maintenance activity. 10. To carry out any job assigned by immediate supervisor / HOD.

1. To perform routine, preventive and breakdown maintenance of plant and Utility equipment. 2. Troubleshooting and maintaining healthiness of plant and Utility equipment. 3. Assisting engineer in modification and improvement activities. 4. Involvement during equipment qualification/validation related activities. 5. Adhere to all company policies & manuals. 6. Strictly adhere to all regulatory and legal compliance. 7. Follow GEP, GMP and GDP during maintenance and project activities. 8. Ensure safety compliance during maintenance of equipment. 9. To maintain equipment cleaning after completion of maintenance activity. 10. To carry out any job assigned by immediate supervisor / HOD.

Works independenly on creating test plans, executing tests, troubleshooting the issues, automating test cases, reporting bugs with all the required details, reviewing the tests, providing the test reports, analyzing test failures Capable of analyzing moderately complex challenges using analytical tools and data interpretation. Applies critical thinking to assess problems with relevant data independently to evaluate potential solutions after considering various possibilities. Engages in independent analysis and collaborates with others to gather insights and develop recommendations including challenging existing processes. Capable of working independently while actively contributing to team a...

Role & responsibilities Executive - QA Equipment Qualification Preferred candidate profile - Review of Equipment Qualification related documentation. - Review of Computer system validation related documentation. - Exposure of Software like EDMS, LMS, Trackwise. - Exposure of Cleaning validation.

This role is responsible for technology transfer, process scale-up, equipment selection, and process validation in API manufacturing. The position ensures that the selected equipment aligns with process requirements, product quality, safety, and regulatory compliance, while supporting continuous improvement and operational excellence. Key Responsibilities: 1. Technology Transfer & Scale-up Lead the transfer of chemical processes from R&D to manufacturing. Evaluate and optimize process parameters for scale-up using mass and energy balances. Collaborate with Engineering for facility fitment, equipment readiness, and plant execution. 2. Equipment Selection & Sizing Analyse process requirements ...

Conduct quality inspections and tests on raw materials, in-process production, and finished products.Monitor and document quality control processes and compliance with quality standards.Identify defects or deviations

Perform routine and non-routine quality control tests using analytical techniques such as HPLC, GC, UV-Vis, IR, titration, and others.Develop, validate, and optimize analytical methods as per regulatory guidelines.

Job Title: Test Engineer - Equipment Qualification Job Description Lead and execute qualification test programs. Perform and execute testing in compliance with quality assurance and safety requirements. Prepare test reports using data and results obtained during testing. Work with project managers and subsystem/component leads to develop and maintain project schedules. Lead complex technical projects, coordinating multi-functional teams to accomplish project objectives while meeting established schedule and budget requirements. Support preparation of requests for quotation (RFQs) and project change offers including scope statements, specifications, costs estimate, plans and schedules. Identi...

As the Plant Manager for the Drug Product Plant at Piramal Critical Care (PCC), your role involves overseeing the overall operations and activities of the plant. You will be responsible for production and manpower planning, ensuring that products are manufactured and stored according to approved procedures to maintain quality standards. Your key responsibilities include: - Overseeing production and manpower planning - Ensuring execution of Batch Production Records as per cGMP requirements - Qualification of equipment and instruments - Conducting product validations in line with regulatory requirements - Monitoring and maintaining stock of consumables, logbooks, and status labels - Coordinati...

Core expertise in IPQA, 21 CFR compliance, validation & qualification, E-BMR/E-Log, QMS, risk assessment; skilled in audits, regulatory compliance, team management, training, and digital quality systems. Required Candidate profile B/MPharma 7 - 10 years of experience

As the individual responsible for the overall operations and activities of the Drug Product Plant, you will play a crucial role in ensuring the production and manpower planning for the plant. Your primary focus will be to oversee that products are manufactured and stored in compliance with approved procedures and documentation to maintain the highest quality standards. It will be your responsibility to review and ensure the execution of Batch Production Records in accordance with cGMP requirements. You will also be in charge of ensuring the qualification of equipment and instruments is carried out as scheduled and that product validations are conducted as per regulatory requirements. Monitor...

The Manager Production Planning and Operational Excellence at Jhagadia and Dahej units is a key role responsible for overseeing the day-to-day plant operations to achieve annual production targets and operational objectives at the manufacturing facilities. This position requires providing leadership, guidance, and direction to enhance production, planning, time cycle efficiency, yield improvement, new plant commissioning, and quality management systems. Key Responsibilities: - Collaborate with VP Operations for technical support and new plant commissioning. - Develop monthly production plans based on BD team requirements. - Implement and monitor Overall Equipment Effectiveness (OEE) to optim...

Preparation of documents such as IQ, OQ, DQ Job Description- (Incumbent needs to do/ Needs to know/ Outcome anticipated) Preparation of Project documents such as IQ, OQ, DQ as per requirement Incumbent needs to know - Basics of documents such as IQ, OQ, DQ - Excel, Word Experience Handling documentation activities for Minimum 6 months, preferably for WT projects in pharma.

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and...

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and...

QA Manager OSD/Liquid formulation background.Must have experience in BMR, batch release,validations,qualifications,SOPs,GMP,audits,QMS(Deviation,OOS, OOT, CAPA), tech transfer. Analytical exposure is an added advantage Resume to hrd@stedmanpharma.com

As a Senior QA Officer, your role will involve various responsibilities to ensure quality assurance within the API pharma industry. You will be tasked with issuing Batch Manufacturing Records, equipment cleaning records, logbooks, and analytical reports for raw materials, finished products, and packing materials. Additionally, you will assist in the preparation of SOPs for different departments and conduct plant rounds to verify documents according to cGMP and GLP norms. Line clearance activities for manufacturing and packaging, issuing deviation forms, change control forms, and handling customer complaints will also be part of your duties. You will review and verify analytical and Batch Man...