670 Process Validation Jobs - Page 3

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...

Job Description: Study product drawings & propose manufacturing process sequence Prepare investment & process costing for new projects/ revisions Conduct DFM with R&D and provide inputs to maintain/ improve manufacturing standards Prepare and verify PFD, PFMEA along with CFT Prepare and monitor NPD development schedule for JFG & Equipment along with Cluster ME Head Sign- off machine specifications along with Maintenance, Production & QA before sharing with suppliers Sign- off test bench specifications along with R&D & Maintenance before sharing with suppliers 8. Validate Civil and MEP requirements for NPD projects. Coordinate with Civil team for capex requirement Raise Capex in system for NP...

Study product drawings & propose manufacturing process sequence along with product lead Participate in DFM with R&D and provide inputs to maintain/ improve manufacturing standards Prepare PFD, PFMEA and sign off with CFT Execute activities as per NPD development schedule defined by Product Lead and Cluster ME Head Prepare machine specifications as per model line and sign off with CFT Prepare test bench specifications along with R&D & Maintenance before sharing with suppliers Define Civil and MEP requirements for NPD projects. Arrange quotations for NPD execution and review with Product Lead/ Cluster Head for Technical Recommendation Conduct concept review with suppliers and facilitate DAP si...

Study product drawings & propose manufacturing process sequence along with product lead Participate in DFM with R&D and provide inputs to maintain/ improve manufacturing standards Prepare PFD, PFMEA and sign off with CFT Execute activities as per NPD development schedule defined by Product Lead and Cluster ME Head Prepare machine specifications as per model line and sign off with CFT Prepare test bench specifications along with R&D & Maintenance before sharing with suppliers Define Civil and MEP requirements for NPD projects. Arrange quotations for NPD execution and review with Product Lead/ Cluster Head for Technical Recommendation Conduct concept review with suppliers and facilitate DAP si...

Role & responsibilities: Preparation and review of SOP. Preparation and monitoring of change control, deviation control. Review and approve the Standard Operation Procedure, Product Quality Reporting System (PQRS), Change control, Deviation controls/Analytical Protocols/Stability protocols/Qualification and validation protocols and reports. In-Process checking during online activities. To ensure timely submission of audit compliances for the deficiency during the inspections/audits Monitoring of GMP compliance. Review of quality documents and analytical data as per pharmacopeia specification, STP, batch card, stability finish product, packaging materials for the purpose of compilation of dos...

Job Description -Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished products for US and IRF market at CMU. -Release of batch manufactured for US and IRF market at CMU -Handling of market complaint with root cause identification and CAPA implementation -Review of documents such as executed BPR, Analytical records, Change Controls, Deviations, OOS, Process Validation, Cleaning Validation, Equipment Qualification, stability data and CAPA for products of US & IRF market. -Provide required documents to Regulatory affairs for variations and updates -Monitoring of process st...

The ideal candidate brings 2 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA,...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Le...

Quality Assurance (QA) based in Latur The ideal candidate brings 0-1years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Strengthen QMS: author/re...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5-8 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improveme...

Could you be the full-time EDU Manager PACIS in Bangalore were looking for? Your future role Take on a new challenge and apply your expertise in on-board electronic systems design in a cutting-edge field. Youll work alongside collaborative and innovative teammates. You'll play a pivotal role in delivering systems that meet customer expectations and align with project schedules. Day-to-day, youll work closely with teams across the business (Project Core Team, Rolling Stock engineering, and Product/Systems development teams), provide design specifications and validation monitoring solutions, and ensure seamless integration of systems and interfaces. Youll specifically take care of system archi...

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. 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...

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...

As an Executive / Sr. Executive in the Quality Assurance department with a focus on In-Process Quality Assurance (IPQA), your role will involve: - Performing Line clearance checks according to procedures and conducting various in-process checks, reconciliation verification during different stages of batch manufacturing and packaging. - Preparation and Review of Executed Batch Manufacturing Record and Batch Packing Records. - Taking responsibility for the preparation of Process Validation Protocols, Process Validation Reports, and SOP's. Qualifications required for this position include: - M.Sc in relevant field - B.Pharm or M.Pharm - 2 to 4 years of experience with relevant experience The co...

Quality Risk Management Batch Manufacturing Record preparation Process Validation Annual Product Quality Review Cleaning Validation Batch card preparation Dossier Preparation Change Control Management Documents preparation New Drug Application Required Candidate profile Experience in Quality Assurance in Pharma Industry Gender Female Location South Kolkata

Ensure current versions of all GMP documents are in use. Prepare, revise, and control SOPs . Implement and enforce (GDP). Conduct internal audits, maintain summaries and CAPA tracking Support in process validation, equipment qualification etc Required Candidate profile Ensure all QA activities comply with cGMP, regulatory requirements & internal quality standards for API & Specialty manufacturing. Contact Mr Deep at 9867038868, Email Id: ops@empowerrecruitments.com

As an Officer/Executive in the Quality Assurance Department at a company located in Bavla, Ahmedabad, your role will involve the following responsibilities: **Role Overview:** You will be responsible for Process Validation and Qualification activities in the pharmaceutical manufacturing industry. **Key Responsibilities:** - Prepare standard operating procedures for various processes - Issue controlled formats to the concerned departments - Provide necessary documents for regulatory dossier submissions - Prepare protocols for Process Validation, cleaning validation, and hold time validation studies - Execute process validation, hold time validation, and cleaning validation activities - Review...

Role Overview: You should have a minimum of 5-10 years of experience in Production, R&D, or formulation development activities. As a Production Manager, your primary responsibilities will include proposing and implementing recommendations to enhance efficiency, safety, and quality, supporting new product development projects, controlling production activities, maintaining high standards of housekeeping and cleanliness, monitoring yield losses, minimizing manufacturing costs, reviewing batch records and documents, preparing and reviewing SOPs, providing on-the-job training, coordinating with QA and QC for validation and in-process checks, and ensuring the maintenance of cGMP standards. Key Re...

Quality Risk Management Batch Manufacturing Record preparation Process Validation Annual Product Quality Review Cleaning Validation Batch card preparation Dossier Preparation Change Control Management Documents preparation New Drug Application Required Candidate profile Experience in Quality Assurance in Pharma Industry Gender Female Location South Kolkata

Job Description Summary Primary focus of this position is to support optimizing, implementing, and validating components/elements of a medical device. The candidate will assist in conducting design and process qualification and validation; assist/write technical documents, validation protocols and reports; perform/coordinate hands-on testing of a device; assist in failure investigations; and support other activities from R&D, Quality, Operations, and Regulatory Affairs. Job Description Essential / Key Job Responsibilities (including supervisory and/or fiscal): Design: serve as subject matter expert of components of a medical device, including design evaluation for proposed changes to materia...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary The position entitles the incumbent to possess adequate practical and technica...