670 Process Validation Jobs - Page 8

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

Role & responsibilities Job Title Manufacturing Engineer/Process Validation Engineer Location – Chennai Delivery looking immediate joiner only Conduct detailed gap assessments of current manufacturing practices against applicable medical regulatory standards (e.g., FDA, ISO 13485, EU MDR, GMP). Review process controls, equipment validation, and quality systems documentation to identify non-compliances and areas for improvement. Identify systemic issues and risk areas related to manufacturing quality, process robustness, and compliance. Support remediation activities including process updates, validation efforts, documentation revisions, and training plans. Strong understanding of regulatory ...

Job Description 1. Monitor raw material dispensing activity. 2. Perform daily IPQA activities as per SOP-defined frequency and ensure timely closure of IPQA observations. 3. Conduct validation sampling as per approved validation protocols. 4. Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy and compliance. 5. Perform ERP-related transactions of IPQA. 6. Check BSR (Batch Summary Record) and Shipper inspection as per SOP. 7. Manage issuance, review, and reconciliation of formats across all departments. 8. Conduct IPQA rounds and share observations with concerned HODs for corrective action and compliance. 9. Ensure cleaning, sanitation, and hygiene in all depa...

Role Overview: You will be responsible for overseeing and supporting the overall activities during the product development life cycle from a quality perspective in R&D (API and intermediates). Your role will involve understanding the site needs for system establishment and sustainability, authoring/reviewing/approving SOPs/work directions, and ensuring effective implementation of quality systems in R&D activities as per GLP and regulatory requirements. Additionally, you will be required to review and approve various reports, conduct periodic audits of the R&D laboratory, ensure effective maintenance of records, and perform cGMP audits of R&D facilities and operations. Training the R&D team f...

We are looking for a skilled Process Validation Engineer to join our team in Pune. The ideal candidate will have 3-10 years of experience in process validation and quality systems, with a strong background in regulatory compliance and hands-on experience in manufacturing activities. Roles and Responsibility Perform gap assessments and conduct remediation of documents with stakeholder inputs. Develop and maintain Manufacturing/Service Work Instructions and related documents. Create/modify process flows within the Manufacturing/Service Departments. Support the development and introduction of new products, processes, and technologies, focusing on quality systems. Monitor and drive corrective ac...

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...

We are looking for a skilled professional with 6-15 years of experience to join our team as an Allegro QA/Developer in PAN India, including Bangalore, Hyderabad, Pune, Chennai, and Noida. The ideal candidate will have expertise in designing Allegro-based functional prototypes and functional modeling of business flows. Roles and Responsibility Design and develop Allegro-based functional prototypes and models. Document functional design, data design, and setup in Allegro. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain high-quality code using Allegro. Troubleshoot and resolve technical issues related to Allegro. Participate in code ...

We are looking for a skilled professional with 5-15 years of experience to join our team as a Zebu Emulation & Validation expert in Bangalore, Chennai, Hyderabad, Kochi, Pune, Noida, and Ahmedabad. The ideal candidate will have a strong background in RTL code development at IP/Sub-system/SoC level and verification methodologies including SV-UVM/C. Roles and Responsibility Design and develop RTL code for IP/Sub-system/SoC level emulation and validation. Develop and implement verification methodologies using SV-UVM/C. Collaborate with cross-functional teams to ensure successful project execution. Analyze and debug emulation results to identify and resolve issues. Develop and maintain technical...

Experienced in preparation,execution&review of process/cleaning validation,equipment qualification,calibration, preventive maintenance, and validation schedules. Ensures effective implementation validation master file. resume to hrd@stedmanpharma.com

Preferred candidate profile Post- Quality Manager Education - BE / DME Mechanical , Post Graduate- CIPET-PPT Email - jobpune22@gmail.com Contact - 9356395439 Experience - 10-15 yrs Location Pune Bhosari / chakan Industry - Automotive Plastics Skills QA audit & documentation, mold validation & defect analysis, problem solving, ISO/IATF , decision making, RCA, Leadership & mentoring Quality System management, inspection & Testing, customer interface, documentation, Team leadership, Process validation, supplier quality, contibous improvement

Safety & Compliance: Assess risks, ensure safety for people and equipment, verify torque and equipment calibration, and maintain conformance with quality and production requirements. Process Validation & Improvement: Participate in production test system validation, identify improvement opportunities, implement projects, and apply APQP for new product introduction. Customer & Team Support: Resolve customer issues, support factory acceptance testing, and provide quality training to local teams for efficient and controlled processes. Control & Effectiveness: Help teams apply effective process management systems, implement internal controls, and ensure control plans mitigate risks. Qualificatio...

Could you be the full-time Senior Process Engineer in Bengaluru were looking for? Your future role Take on a new challenge and apply your manufacturing process expertise in a cutting-edge field. Youll work alongside collaborative and innovative teammates. You'll help shape the manufacturing process and ensure its alignment with industrial policies and project constraints. Day-to-day, youll work closely with teams across the business (Engineering, Production, and Quality), develop industrial documentation, and enhance production efficiency through process validation and optimization. Youll specifically take care of defining workstation layouts and performing line balancing, but also support p...

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.

Roles and Responsibilities To be handle all API pharma equipment w.r.t. manufacturing. Perform operation related activities. Ensure compliance with regulatory requirements. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Maintain accurate records, reports, and documentation. Desired Candidate Profile having experience in API pharma industries. Strong understanding of Good Manufacturing Practices (GMP) regulations. Experience with Cleaning Validation & Equipment Qualification procedures.

Hiring Process Engineer – Injection Molding (CIPET Diploma, 1–3 yrs). Expertise in scientific molding, process optimization, troubleshooting, and quality improvement. Location: Kanakapura Production Dept.

As a Sr. Validation Engineer at CMIC CMO USA Corporation in Cranbury, NJ, your role involves utilizing pharmaceutical science analytics to author validation protocols in compliance with cGMP/FDA standards. You will be responsible for planning, managing, and executing start-up, commissioning, and validation of new pharmaceutical equipment. Additionally, you will draft and implement qualification protocols, resolve deviations and CAPA, prepare validation reports, develop SOPs for manufacturing and packaging equipment, as well as write test protocols. **Key Responsibilities:** - Author validation protocols in compliance with cGMP/FDA standards - Plan, manage, and execute start-up, commissioning...

This Position reports to: Production Manager Your role and responsibilities You will be working as Quality Control Specialist look after Consistency and quality are top priorities for any manufacturer. But even with standards and specifications in place for employees to follow, businesses depend on quality engineers to verify that those standards are always met and that only the best products make it to market. The work model for the role is: #Li-Onsite This role is contributing to the ABB India, Smart Power, as a Quality Control Specialist for Nelamangala Bangalore Location. You will be mainly accountable for: Safety & Compliance: Assess risks, ensure safety for people and equipment, verify...

The Senior Process & Proposal Manager will lead the preparation, management, and submission of proposals for EPC projects and skid packages within the Oil & Gas sector. With more than 13 years of proven expertise, the role demands strong technical knowledge of process equipment and modular skid packages, coupled with commercial acumen to manage pre-bid and post-bid activities. The incumbent will play a critical role in winning projects by developing competitive, compliant, and technically sound proposals Role & responsibilities Proposal Management Lead pre-bid and post-bid activities for EPC projects, modular skid packages, and process systems. Develop techno-commercial proposals, BOQ, costi...

About The Role : Job TitleTrading Enabler - VP LocationMumbai, India Role Description The candidate will be part of the Asset & Liability Management (ALM) function and responsible for reducing model risk associated with interest rate risk in the banking book (IRRBB) measurements. The team acts as an intermediary in treasury itself and between the business units and other central functions like Market Risk Management and Model Risk Management. This gives you a unique view into many exciting and important topics. Treasury Treasury at Deutsche Bank is responsible for sourcing, managing, and optimizing Deutsche Bank's financial resources and providing high-quality steering to the Bank on financi...

Well look to you for: Gathering industrial requirements and ensuring Engineering complies during product specification and design. Participating in co-engineering activities to design processes and introduce new technologies. Developing specifications for industrial means and defining workstation layouts adhering to ergonomic and EHS rules. Performing P-FMEA and macro-process design, including line balancing and process validation. Leading validation of prototypes and ensuring smooth transition to serial production. Supporting production teams post-serial Go and managing retrofit industrialization after engineering changes. Providing expertise to the Industrial Costing Manager during tenders...

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....

Responsibilities: Conduct process validation studies Ensure compliance with regulatory requirements Manage vendor qualifications Lead cleaning validation processes Oversee IPQA activities Flexi working

Role Overview: Valeo, a tech global company, is seeking a Process/Manufacturing Engineering Engineer/Technician to join their Technical Center team. As part of the team, you will be involved in the industrialization of the new P1, improving production efficiency, and leading Lean design workshops. You will work in a dynamic environment with a focus on innovation and sustainability. Key Responsibilities: - Manage the introduction of production equipment using IPROM - Collaborate with suppliers to develop equipment and assembly lines - Design small tools and validate supplier proposals - Define acceptance criteria for new equipment or lines - Perform trials on production lines and generate rep...

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...

1 Responsible for the Handling of market complaint at site. 2 Responsible for the Handling of Deviation management at site. 3 Responsible for the Handling of CAPA and Global CAPA management and effectiveness checking at site. 4 Responsible to co-ordinate the execution of mock recall and market recall. 5 Responsible to review and tracking of Audit Responses. 6 Responsible to raise, review and tracking of Quality Alert. 7 Responsible to ensure timely closure of QMS documents. 8 To perform activity as per authorization in EDMS, LMS and TRACKWISE software. 9 Responsible for performing IPQA activities. 10 To perform process validation and cleaning validation sampling activity in shop floor. 11 To...