667 Process Validation Jobs

Role Overview: You will be working as a Subject Matter Expert (SME) in Grinding and Honing as a Process Engineer/Process Expert at SKF's Ahmedabad Manufacturing Plant. Your main responsibilities will include driving process improvements, supporting new product development, and ensuring the smooth execution of grinding and honing operations during the factory expansion phase. Your role will involve commissioning new machines, optimizing cycle times, and implementing advanced manufacturing techniques to enhance productivity and quality. Key Responsibilities: - Serve as the technical expert for grinding and honing operations during the factory expansion phase. - Lead the installation, commissio...

As a Manufacturing Supervisor, you will be responsible for planning and organizing the production process with a focus on maintaining quality control standards. Your key responsibilities will include: - Running and monitoring the production process to ensure optimal and safe operation. - Troubleshooting to identify and resolve operational issues efficiently. - Implementing quality control programs to monitor product standards. - Managing a team, defining goals, communicating objectives, and monitoring team performance. - Ensuring all activities adhere to required procedures. Qualifications Required: - B. E. (Chemical) or M. Sc. (Organic Chemistry) - Strong problem-solving skills - Proficienc...

Job Description: As a Quality Compliance Officer in a manufacturing environment, your primary responsibility will be to ensure quality compliance, documentation, and adherence to industry standards. You will play a crucial role in maintaining the quality of products through various checks and inspections. Key Responsibilities: - Conduct quality checks and inspections of raw materials & finished products to maintain high standards. - Ensure compliance with Good Manufacturing Practices (GMP), International Organization for Standardization (ISO), and other regulatory standards. - Maintain quality documentation accurately and assist in audits to validate compliance. - Support process validation ...

Job Description: You will be responsible for commercial batch release to market and in-process Quality Assurance activities. This includes conducting in-process Quality Assurance checks during Manufacturing, packing operations, and line clearance of manufacturing, packing, and dispensing activities. Additionally, you will assure cleaning, sterilization, and aseptic manipulations of components, as well as sampling of Cleaning Validation & Compilation of the records. You will also be responsible for Sampling & compilation of Process Validation Reports (PVRs) and sampling and coordination during validation studies (process / cleaning validation). Routine monitoring of Manufacturing Areas, good ...

Job Description You will be responsible for ensuring strict adherence to safety protocols, SOPs, and quality standards, overseeing batch manufacturing activities, and coordinating with various departments to maintain operational efficiency. Your role will involve planning and executing production activities, coordinating with cross-functional teams, and ensuring compliance with regulatory requirements critical for maintaining product quality and meeting production targets. - Adherence to company safety norms, policies, and SOPs (Standard Operating Procedures). - Overseeing batch manufacturing activities according to e-BMR instructions and workflow, ensuring submission of executed e-BMR and w...

As an experienced and dynamic professional in the pharmaceutical industry, you have the opportunity to join Ananta Medicare Ltd in Sri Ganganagar, Rajasthan, specifically in the Quality Assurance Department for Validation activities in a manufacturing facility. Your role will involve hands-on experience in qualification and validation activities for a sterile / Cepha manufacturing setup. Key Responsibilities: - Execution and review of Qualification activities for Equipment, Utilities, and Facilities (URS, DQ, IQ, OQ, PQ). - Preparation and review of validation protocols and reports (Process Validation, Cleaning Validation, Sterilization Validation, HVAC Qualification, etc.). - Coordination w...

1. To prepare annual equipment qualification planner with respect to validationmaster plan. 2. To prepare HVAC / compressed air / effectiveness of cleaning validation planner. 3. Preparation of protocols for qualifications of newly procured equipments and ofequipments transferred from other location. 4. Preparation of protocols for re-qualifications of HVAC system. 5. Preparation and execution of re-qualification protocols and reports as per schedule ofvalidation master plan and as on when required. 6. Toperform cleaning validation cleaning verification. 7. Preparationreview of cleaning assessment report. 8. Preparation review of process validation protocols and reports. 9. Preparation revie...

Issuance of Analytical Data Sheets and Formats. Preparation and Review of specification and standard test procedure. Review of QC Analytical Data. To ensure online documentation in laboratory as Good Documentation Practices. To attend training as per refresher training schedule. To ensure all time audit readiness in the work area. To perform any other work as and when assigned by Head of department.

1. Line clearance in dispensing, manufacturing and packing area 2. In -Process Quality Assurance activities, sampling, analysis and AQL during production. 3. To ensure stage wise completeness of BMR during production. 4. Monitoring of environmental conditions in production area. 5. Coordination with other departments for smooth running of the plant. 6. Calibration, verification and maintenance of IPQA instruments. 7. To monitor process as per technical directions. 8. To fill all IPQA sampling logs in time. 9. To ensure deviations are properly documented and CAPA implemented. 10. To withdraw samples at different stages of In-Process and finished product as well as validation samples as per TD...

1. To supervise and review the Physicochemical, Critical System and Chromatography lab analysis of in-process, intermediate and formulated bulk samples. 2. To supervise and review the Molecular Biology lab analysis of in-process, intermediate and formulated bulk samples 3. To plan the daily activities of the laboratories as per the production plan co-ordination with CFT for alignment. 4. To review the logs and records in Physicochemical, Critical system, Molecular biology, Electrophoresis and chromatography Lab. 5. Review and approve protocols and reports such as method validation, method transfer, process validation. 6. To review the calibration and revalidation of all the equipments of Phy...

Preference to Immediate Joiner Company: Ananta Medicare Ltd, Sri Ganganagar, Rajasthan Ananta Medicare Ltd is looking for an experienced and dynamic professional to join our Quality Assurance Department for Validation activities in a manufacturing facility with hands-on experience in qualification and validation activities for a sterile / Cepha manufacturing setup. Key Responsibilities: Execution and review of Qualification activities for Equipment, Utilities, and Facilities (URS, DQ, IQ, OQ, PQ). Preparation and review of validation protocols and reports (Process Validation, Cleaning Validation, Sterilization Validation, HVAC Qualification, etc.). Coordination with Production, QC, and Engin...

Co-ordination & Ensuring timely execution of Sampling activity of Raw and Packing materials. Preparation, Review and updating of standard operating procedure. To ensure line clearance for dispensing, sampling and packing activity. Routine monitoring of all functional area to ensure adherence to the SOPs. Create signature and methods for raw materials by using Truscan RM analyzer. Approved / Rejected labels affixing for API, Excipients, Primary packing and secondary packing materials finished goods and operation supplies. Verification of Temperature and Relative Humidity reports generated from TESTO software. To perform the QMS (change control) activities as per access approvals. To perform n...

protocol & reports of equipment / utility qualification Responsible for execution of equipment / utility qualification. process validation cleaning validation Annual Product review Validation Master Plan. Computer System Validation/ PLC validation Perks and benefits Food & Transportation, Bonus & Gratuity Separately

Job Title: Officer -QA Business Unit: Global Quality And Compliance Job Grade G12C 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: To give the line clearance as per BMR/BPR...

Role & responsibilities To ensure cGMP Compliance as per laid down procedures. Monitoring overall all QA activities - Process validation, Cleaning Validation, Equipment Qualification and Master Document review. Preparation and review of SOPs applicable to QA. Evaluation of QMS documents. Preparation of Validation Master Plan, review of process validation, equipment qualification and cleaning validation protocols and reports Participate in investigations and review of investigations. Monitoring of Exhibit and Submission batches documentation and Coordination with RA for document submission Monitoring of document control, storage, and archival. To provide training to QA team members and other ...

Job Description Summary Seeking a senior level engineer who is a highly organized and results-driven professional with strong project management skills to lead complex, cross-functional initiatives. Primary focus of this position is to oversee and support strategic projects including Global UDI implementation, Product Stewardship (covering SDS, REA, PFAS/REACH, RAM, SVT, etc.), Lot Grading, Microplastics, Canadian Plastics compliance, etc. Role includes managerial responsibility to ensure R&D Sustaining requests and Product Stewardship initiates are delivered upon with high quality and timeliness. The candidate should be comfortable navigating regulatory landscapes, driving process improveme...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Pall Corporation, one of 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global cu...

Job Description Preparation and updation of Validation Master Plan (VMP) Preparation of Process validation, Computer system validation protocol and report. Preparation of product matrix and Cleaning Validation/verification protocol and Report. Preparation of qualification and requalification protocol and report for processing equipment/instrument, utilities, and facility. Preparation of area validation protocol and reports. Preparation and review of quality risk assessments. Review of calibration certificate (External/internal). Preparation, issuance, review & archival of BMR/BPR. Batch Record storage, retrieval & destruction. Preparation of APQR. Line Clearance for Manufacturing, Packing & ...

JOB DETAILS Proven hands-on experience with HPLC and LC-MS techniques. Strong background in method development and validation processes. Ability to plan, coordinate, and execute projects from initiation to completion, ensuring timelines, budgets, and quality standards are met. Track and report progress on ongoing projects to Management Minimum 3+ years of hands-on experience in supervising, mentoring, and guiding both junior and senior research associates. Ensure accurate documentation and maintenance of research and experimental data in alignment with company policies and regulatory standards. Should take care of maintenance and preventive maintenance of instruments. Ability to identify and...

Key Roles and Responsibilities 1. Documentation and Record Management Prepare Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) . Prepare and maintain Process Validation Protocols , Process Validation Reports , and Stability Protocols . Prepare Maximum Hold Time Study Protocols and maintain the Hold Study Program . Maintain the Change History of all controlled documents and records. Issue and track BMRs , BPRs , SOPs , formats, and registers to the concerned departments. Perform batch reconciliation and review of executed BMRs and BPRs. 2. Validation and Qualification Review and approve method validation data , stability protocols , and sampling protocols . Review and monitor v...

Responsibilities: Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product. Review of raw material related documentation and release of raw materials Provide quality support for the development of appropriate Corrective and Preventative Actions (CAPAs) Provide advice to departments regarding GMP compliance Review and approve QA controlled documentation such as SOPs, batch records, working instructions Assessing change control requests on consistency, relevance, GMP compliance and clarity Assist with writing, revising, and approving standard operating procedures. Review and preparation of batch release documentation Sup...

Role & responsibilities 1 Preparation of standard operating procedure. 2 Preparation of quality documents. 3 Initiate / review of change control system. 4 Initiate / review of deviation. 5 Initiate / review of CAPA. 6 To control, issue, retrieve, retention and disposal of GMP documents as per standard procedure. 7 Review of MFR/BMR/BPR/ECR. 8 Review of validation protocols and report. 9 To participate in investigation of OOS for RM/intermediate/FP. 10 To participate in market complaint handling. 11 Review of vendor qualification documents. 12 Review of executed manufacturing and analytical records. 13 Preparation of annual product quality review. 14 To take plant round and ensure compliance ...

Role Overview: As a part of the engineering team, your role will involve preparing Equipment Qualification Protocols and performing Qualifications. You will be expected to understand, study, and develop user requirement specification for any automation project in the production department. Additionally, you will identify and prepare process improvements, prepare Process Validation Protocols, and perform Validations. Maintaining records as per WHO GMP / ISO requirements, training subordinates, and carrying out any other job assigned by your superior will also be part of your responsibilities. Key Responsibilities: - Understand, study, and develop user requirement specification for automation ...

1. Quality Systems & Documentation: Develop, implement, and maintain GMP-compliant QMS. Oversee change control, deviations, CAPA, incident management, risk assessment, and market complaints. Ensure GDP compliance in all QA documentation, including SOPs, batch records, specifications, and MOAs. Prepare and revise SOPs, distribute and retrieve old versions, and manage documentation control. Handle QMS activities like return goods, non-conformities, and investigation reports (5-Why, 6M method). 2. Validation & Qualification: Review and approve URS, IQ, DQ, OQ, and PQ protocols and reports. Manage process validation, cleaning validation, equipment qualification, and facility validation. Conduct ...

Job Description Summary Seeking a senior level engineer who is a highly organized and results-driven professional with strong project management skills to lead complex, cross-functional initiatives. Primary focus of this position is to oversee and support strategic projects including Global UDI implementation, Product Stewardship (covering SDS, REA, PFAS/REACH, RAM, SVT, etc.), Lot Grading, Microplastics, Canadian Plastics compliance, etc. Role includes managerial responsibility to ensure R&D Sustaining requests and Product Stewardship initiates are delivered upon with high quality and timeliness. The candidate should be comfortable navigating regulatory landscapes, driving process improveme...