223 Equipment Qualification Jobs - Page 3

Job title: Sr. Executive - Plant Engineering , Pharma Educational Qualification. Bachelor's Degree (B.E.) in Mechanical / Instrumentation Engineering from a reputed college. Work Experience 8 to 10 years of working experience in Pharmaceutical Formulations Key Accountabilities Responsible for troubleshooting and breakdown maintenance of packing equipment (Blister packaging and cartonator, serialization machines), and minimizing equipment downtime. Corrective & Preventive maintenance to eliminate recurring failures in the equipment. Execution of monthly / Quarterly and Annual Preventive maintenance of the equipment and operating the same to achieve the target of 100% completion against the sc...

Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research & Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research D...

Responsible to harmonize, ensure and standardize policies and procedures for computerized system validations and ensure effective implementation of the computerized system validation in coordination with corporate quality and with all departments of the plant with respect to Computer System Validation (CSV) Responsible to assist site personnel/management in developing protocols, test cases, validation packages, etc for validations of computerized system Responsible to evaluate validation requirement for computerized systems used for GxP purposes in various department of the plant Provide guidance on the interpretation of regulatory requirement and guidelines for GxP Computerized systems from...

We have urgent Requirement for : Department : Quality Assurance Designation : Executive Skills Required : Process Validation, Equipment Qualification, QMS, APQR, Capa, Cleaning Validation. Experience Required : 03 to 08 years Salary : Depend upon Interview Location : Nalagarh interested candidate can contact @ 7717304694 or can send their Resume at hr2@theonpharma.com

Job Description Candidate should have sound knowledge about upstream process development (Cell culture and Fermentation). Hands on experience of shake flask studies including sample analysis and documentation. Experience in handling and operation of cell culture and microbial related experiments in bioreactor including sample analysis and documentation. Aseptic handling of seed inoculum and its maintenance Independently handle media and feed preparation for conducting studies. Should be able to trouble shoot in case of any deviation from process/parameter. Good documentation practice. Should be able to perform cell culture (IPQC) analysis. Preparation of SOP, Support for Equipment qualificat...

Job Description Position: QA Sterile Manager Department: Quality Assurance Designation: Manager - I Education Qualification: M.Sc. in Biotechnology / Microbiology / Chemistry Total years of Experience: 10+ Years Job Role: Management of Quality Assurance functions of Manufacturing Block P. Responsibilities Ensure that manufacturing and packing of the batch is executed and records are completed and reviewed in accordance with established SOPs and cGMP regulations. Conduct certification of batch production records for compliance and stage-wise completion. To release / reject the Batch after complete review of batch and related quality documentation. Tracking and monitoring of QMS system. Ensure...

As a Production and Manufacturing Specialist, you will play a crucial role in ensuring the smooth functioning of production activities. Your key responsibilities will include: - Preparing work instructions for Production and manufacturing activities. - Carrying out production activities as per the production plan. - Monitoring the batch process to maintain efficiency. - Maintaining online documentation related to production activities like BMR, BPRs, logbooks, and daily records. - Qualification of production equipment and active participation in validation activities. - Taking line clearance at various stages for a streamlined process. - Issuing requisitions to the store department for Raw m...

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team. The ideal candidate will have expertise in ServiceNow and HPALM. Roles and Responsibility Manage and implement CSV solutions using ServiceNow and HPALM. Collaborate with cross-functional teams to ensure seamless integration of CSV with other systems. Develop and maintain documentation for CSV processes and procedures. Troubleshoot and resolve issues related to CSV implementation. Provide training and support to end-users on CSV tools and features. Ensure compliance with industry standards and best practices for CSV management. Job Requirements Strong knowledge of ServiceNow and HPALM. Experience in managin...

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Role & responsibilities : Equipment Qualification DPI liquid Injection Cleaning Validation Ampoule ,Vial Washing Media Fill Leak Test Line Clearance In Process Validation( Related to sampling ) Dental cartridge BMR/BPR

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...