678 Process Validation Jobs - Page 2

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...

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...

Core Purpose of the Role: Experience - 8 to 10 years Line Clearance process overview, Product change over. Timely area readiness (Cleaning, EMS, OOS status) and ensures availability of documents and material status. Monitoring of process through process step verification. Reviewal of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions. Equipment / utility Qualifications, Calibrations, PM verification. Utility / Computer system validation Process validation and cleaning validation. Target Monitoring for batch related process activities. cGMP compliance and verification overview of BMP facility & Utilities. SOP preparation and review. Traini...

Responsibilities: Monitor manufacturing and packaging processes, including line clearance and in-process checks (IPQA) Manage documentation activities, including DOC-QMS systems, SOP preparation, deviation handling, and change control Support Technology Transfer (TT) activities by reviewing protocols, executing processes, and coordinating between R&D and manufacturing teams Ensure compliance with 21 CFR Part 11 requirements through validated software systems for electronic records and signatures Execute equipment qualification (DQ, IQ, OQ, PQ), process validation, and cleaning validation activities Utilize automated quality systems and digital platforms for manufacturing documentation Mainta...

Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the quality control laboratory in ensuring that all testing is performed in accordance with regulat...

About The Role Project Role : Data Platform Engineer Project Role Description : Assists with the data platform blueprint and design, encompassing the relevant data platform components. Collaborates with the Integration Architects and Data Architects to ensure cohesive integration between systems and data models. Must have skills : Graph Databases Good to have skills : Python (Programming Language) Minimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Data Platform Engineer, you will be responsible for assisting with the blueprint and design of the data platform components. Your typical day will involve collaborating with Integrat...

Responsibilities: Participate in management review meetings. Review of department trend analysis reports and internal studies or investigations. Ensure corrective action is initiated when required. Provide complete analysis of test results, investigation or information studies. Be capable of assuming study director responsibilities for all routine testing as well as certain advanced or specialized studies as requested by clients. Duties may include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis. Maintain thorough knowledge and understanding of all SOPs pertaining to microbiology/sterility assuran...

We are seeking a highly skilled and motivated Process Engineer to join our team at Morepen Laboratories Ltd, a leading organization dealing in manufacturing of home diagnostics medical devices. The Process Engineer will play a crucial role in optimizing manufacturing processes, ensuring product quality, and driving continuous improvement initiatives. This role requires a strong understanding of manufacturing principles, medical device regulations, and process improvement methodologies. Role & responsibilities Process Optimization: * Analyze and optimize manufacturing processes to improve efficiency, reduce costs, and enhance product quality. * Develop, implement, and validate process improve...

Responsibilities: Ensuring Compliances: Quality Assurance professionals play an important role in ensuring that all processes & product comply with QMS/IMS and other relevant regulations. Quality Control: Quality Assurance professionals involved in the development, maintenance & implementation of procedures and system in QC and production. Documentation: QA professionals review and approve documents such as SOPs, batch record & other quality related documents. Audits & inspections: They conduct audits & inspections to ensure compliances with regulations & identify areas for improvements. Investigation & Corrective Action: They investigate deviations or non-conformance & implement corrective ...

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...

We are looking for a highly skilled and creative Project Specialist to join our team at Novartis India. The ideal candidate will have a strong background in IT Services & Consulting, with excellent project management skills and the ability to work collaboratively with cross-functional teams. Roles and Responsibility Manage multiple projects simultaneously, ensuring timely completion and meeting deadlines. Coordinate with stakeholders to gather requirements, provide updates, and address concerns. Develop and maintain project plans, schedules, and budgets for successful execution. Collaborate with team members to identify and mitigate risks, improving overall project quality. Communicate proje...

Roles and Responsibilities Conduct Process Validation, Equipment Qualification, and Cleaning Validation activities according to SOPs. Prepare documents for Capa, MACO, OSD, and SOP preparation. Ensure compliance with regulatory requirements through quality control measures. Collaborate with cross-functional teams to resolve quality issues. Maintain accurate records of all quality-related activities. Desired Candidate Profile 5-10 years of experience in Quality Assurance (QA) or related field. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Strong understanding of pharmaceutical industry regulations and standards. Proficiency in equipment qualification, cle...

You will be responsible for the following key responsibilities: - Deviation Management - Quality System Implementation - Regulatory Compliance - Process Validation - Documentations & Audits You should possess the following qualifications: - M.Sc. in Chemistry Please note that the work location is in person and the job type is full-time, permanent. Additionally, the benefits include Provident Fund, and the schedule is day shift.,

Role & responsibilities :1 1.Process Validation Sampling. 2. Process Validation Protocol Preparation And Filling. Carrying Out Internal Audits. 3. Daily QA Rounds. Carryout IQ,OQ,PQ Of New Equipment Installed In Factory. 4. Review And Control Of SOP'S ,Specification, Master Manufacturing Formula And Records. 5. In Process Quality Checks of Semi-Finished Products Tablets &Capsules. 6.Bonded Store Room Checking Records of Finished Products. 7.Line Clearance IPQA Of Dispensing,Manufacturing,Packing And Dispatch Activities. 8. BMR ,BPR Preparation/Review/Issuance Preferred candidate profile

Department Quality Assurance Section Documentation Designation Deputy Manager Qualification M.Pharmacy / B.Pharmacy EXP Required 12 Years Reporting to Sr. Manager Sr. No. Responsibility Responsible for Preparation, Review of Process Validation, Cleaning validation protocol & reports. 2 Responsible for Execution of Process Validation, cleaning validation activity. 3 Responsible for Preparation. Review of hold time study protocol & reports, Execution of hold time study against planner. 4 Responsible for Preparation of Standard operating procedure. 5 Responsible to provide Personal training. 6 To ensure complete documentation, control and retention of validation documents against activity done....