288 Equipment Qualification Jobs - Page 6

We are looking for a skilled Validation Engineer with 5 to 8 years of experience. The ideal candidate will have a strong background in validation and CSV experience, as well as knowledge of IQ, OQ, and PQ processes. Roles and Responsibility Design and develop test cases for validation purposes. Collaborate with cross-functional teams to identify and resolve issues. Develop and maintain documentation of validation processes and results. Analyze data to identify trends and areas for improvement. Participate in audits and ensure compliance with regulatory requirements. Provide training and support to junior team members. Job Requirements Bachelor's or Master's degree in Engineering (BE/BTech) o...

Questions before applyingPlease contact PVYN@nne Please note we only accept applications submitted through our online recruitment system You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV To ensure an efficient and fair recruitment process, we encourage you to refrain from adding a photo in your CV At NNE, we commit to an inclusive recruitment process and equality of opportunity for all our job applicants We will invite to interviews on a running basis To learn more about us visit nne

Manage QMS docs per regulatory standards. Prepare, review QRA, validation, complaints, audits, PQR, SMF, manuals. Align with teams, support audits, SOPs, training, reviews, and drive continuous improvement. Perks and benefits Bachelor's Accommodation and Travelling benefit.

I am looking for a database resource for Integral IQ that is suitable for professionals with 3-6 years of experience and a strong foundation in database concepts

I am looking for a database resource for Integral IQ that is suitable for professionals with 2-4 years of experience and a strong foundation in database concepts

Handling of QMS System (Change Control, deviations, OOS, OOT, CAPA, etc.) Validation Activities Aware of Equipment / Instruments qualifications Good Knowledge of SOP preparation & Review Good Knowledge of APQR Aware of Internal Audit Activities

Preparation of SOPs ,Protocols i.e One time studies, method validations required for the microbiology laboratory. Assessment of Equipment design versus URS/Design qualification. Hands on experience on green field projects i.e new laboratory Set-up , AHU, Facility and equipment qualifications. Microbiology equipment qualifications and to ensure instruments / equipment's CSV, calibration, performance verification, preventive maintenance checks (PMP) as per the schedule. Responsible for review, closure of reports and submission to cross functional departments. To ensure the availability of necessary resources (consumables) for smooth and timely execution of the analysis. To initiate and partici...

Role & responsibilities Executive - Quality Assurance Preferred candidate profile Review of Equipment Qualification related documentation. Review of Computer System Validation related documentation. Exposure of Cleaning Validation. Exposure of Software like EDMS, LMS, Trackwise.

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Unique Opportunity Thermo Fisher Scientific Inc. seeks a Sr Packaging/Labeling Technician to support premier packaging and labeling. Job Responsibilities Handle and perform floor level activities of secondary packaging to complete the packaging jobs within defined timelines and with the desired quality standards. Ensure that all team members technically adh...

Planning and execution of preventive maintenance of Process equipment- Vial filling, vial washing, Tunnel, isolators. Online entering check list for carrying a preventive maintenance as per SOPs. Attending breakdown maintenance in compliance with cGMP of process equipment's. Following the cGMP, GDP and safety while carrying out all activities. Maintaining good co-ordination with other department to sort out plant maintenance issues. Spares Management for all process equipment's. Operation and maintenance of HVAC system. Ensure maintaining of clean room parameters and trouble shooting. Operation of HVAC Requalification. To communicate relevant EHS issues to concerned person. Plan and preparat...

Educational Requirements Master of Pharmacy,Master Of Technology,Bachelor of Pharmacy (Honors),Bachelor Of Science,Bachelor of Engineering,Bachelor Of Technology Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS...

Key Responsibilities: 1. Execution of Plant-Level Validation Activities Coordinate and execute process validation, cleaning validation, and hold time studies on shop floor. Monitor and record critical process parameters (CPPs) during validation batches. Ensure adherence to batch manufacturing records (BMRs) and protocols during execution. 2. Documentation & Review Prepare and review process validation protocols, reports, and summary documents . Maintain validation documentation as per SOPs and data integrity requirements. Compile analytical results and production data for validation reports. 3. Compliance & GMP Adherence Ensure execution is in compliance with SOPs, cGMP, and regulatory guide...

Job Title: Manager 2 - Biotechnology Business Unit: R&D1 Regulatory Affairs Job Grade G11A Location Baroda 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 SunshineAs 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. Job Description Sound knowledge about upstream process development (Cel...

As a QA Assistant Manager with 5-7 years of experience in the pharmaceutical industry, your role will involve running the department independently. You should possess strong skills in inter and intra-departmental communication, a desire to learn, and the ability to adapt and adopt to people and systems effectively. This position is based in Mumbai. Your key responsibilities will include: - Skilled handling of FDA-GMP audits to ensure compliance with regulatory standards. - Experience in establishing robust Quality Management Systems (QMS) to ensure compliance with GLP and cGMP standards. - Expertise in creating, reviewing, and maintaining Standard Operating Procedures (SOPs). - Managing and ...

Role Overview: You will be responsible for ensuring the timely and compliant review of CMC documentation, Method Development/Validation Protocols & Reports, Stability Protocols & Reports, Instrument/Equipment Qualification records, and BMR. You will also be involved in compiling high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various sites, liaising with third party contract manufacturers, and recommending actions for continuous improvement in product quality. Additionally, you will participate in Quality Management Systems, Performance Management, Training, and provide miscellaneous support as needed. Key Responsibilities: - Review CM...

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.