670 Process Validation Jobs - Page 11

Core expertise in IPQA, 21 CFR compliance, validation & qualification, E-BMR/E-Log, QMS, risk assessment; skilled in audits, regulatory compliance, team management, training, and digital quality systems. Required Candidate profile B/MPharma 7 - 10 years of experience

You should have a minimum of 10 to 15 years of experience in the QA department of Pharmaceutical formulation. Your responsibilities will include having knowledge of regulatory requirements and documentation such as water validation, process validation, incident management, change control, CAPA, etc. It is essential for you to be capable of providing training to junior staff. Familiarity with WHO GMP/cGMP is a requirement. The ideal candidate will hold an M.Pharm/B.Pharm/M.Sc. degree.,

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their busines...

Job Description 1. Preparation and review of operational packing materials list, Packaging materials specifications, Packaging materials specifications base documents, BOM, BPR (PAS X and SAP), In House Labels for Exhibit Batches, Pack Split Up and Pallet Matrix. 2. To provided technical support to Production, QA, QC and RA. 3. Review of Artwork, Shade cards and print proof etc. Initiate Change controls, Deviation and CAPA and close all action item of change control, CAPA and deviation within time frame preparation of investigation report of deviation. Coordinate with R&D and QA for Primary Packaging Materials Specifications, Primary Pack Specification and Standard Test Procedures. 4. Prepar...

Experience in Vaccine/Injectable/Sterile manufacturing setup Review and evaluate facility, utility, process equipment & instrument design Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ documents Conduct Computer System Validation (CSV) as per GAMP & 21 CFR Part 11 Coordinate with project teams to meet timelines and milestones Ensure compliance with GMP and regulatory standards Investigate deviations, failures, and non-conformances Identify root causes and implement CAPA Support audits and inspection readiness activities Job Location: Kadi, Gujarat ( Bus facility available for daily commute) Note: Immediate joiners will be preferred first

Instrument Handling - pH Meter, Analytical Balance, Friability Tester, Disintegration Apparatus, Hot Air Oven, Moisture Balance, UV Sprct. Raw & Packing Material Testing Strong GLP Adherence Robust GMP Documentation Regulatory Compliance Awareness Required Candidate profile Experience: 2–3 years in pharmaceutical Quality Control Strong knowledge of analytical instruments and QC procedures Soft Skills: Detail-oriented, organized, good interpersonal & communication skills

The job involves various responsibilities related to quality assurance and production operations in the pharmaceutical industry. Your main tasks will include conducting line clearance for production operations, reviewing Batch Manufacturing Records (BMR), Batch Formula Records (BFR), and Batch Packing Records (BPR), performing in-process QA functions, managing control samples, collecting in-process/finished product and customer samples, compiling Annual Product Quality Review (APQR) data with trend analysis, participating in process validation and hold time studies, coordinating batch release, and performing routine Good Manufacturing Practices (GMP) verification in production, warehouse, an...

You will be joining Sun Pharmaceutical Industries Ltd as a QA Sterile Manager in the Quality Assurance department. Your role will involve managing the Quality Assurance functions of the Manufacturing Block P. As the Manager-I, you are required to hold an M.Sc. degree in Biotechnology, Microbiology, or Chemistry with over 10 years of experience in the field. Your responsibilities will include ensuring that manufacturing and packing processes are carried out per SOPs and cGMP regulations. You will be responsible for certifying batch production records, releasing/rejecting batches after thorough reviews, and tracking the QMS system. It will be your duty to investigate complaints, deviations, OO...

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 departments to maint...

We are looking for a highly skilled and experienced Officer, Quality Assurance to join our team in India. The ideal candidate will have 2-5 years of experience in the field. Roles and Responsibility Develop and implement quality control processes to ensure compliance with regulatory requirements. Conduct regular audits to identify areas for improvement and implement corrective actions. Collaborate with cross-functional teams to resolve quality-related issues and improve overall performance. Analyze data to identify trends and opportunities for quality improvement. Develop and maintain quality metrics and reports to track performance. Ensure all products meet required standards before release...

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Job Overview TE Connectivity's Quality Control and Reliability Teams ensure product and / or product components comply with specifications and quality standards. They test and inspect products against performance and integrity criteria to ensure product quality and reliability, and to determine the suitability of product release. Responsibilities The AQE team leader will be responsible for leading and managing a team of 4 - 5 advanced quality engineers on the Quality system activities in APQP & PPAP. Understand Customer drawings, Technical requirements, Quality requirements, CSR and cascade the requirements to CFT Exposure to Design and process validation testing and understanding test speci...

QA Manager OSD/Liquid formulation background.Must have experience in BMR, batch release,validations,qualifications,SOPs,GMP,audits,QMS(Deviation,OOS, OOT, CAPA), tech transfer. Analytical exposure is an added advantage Resume to hrd@stedmanpharma.com

Job Description 1 Should have knowledge of Ophthalmic Dosage Forms manufacturing process – Solutions, Suspensions and Emulsions 2 Should be well versed with Process Development, Process Design and Process validation. 3 Should have awareness of regulatory guidance for USA/EU and other regulatory markets. 4 Execution of Development, Scale up, exhibit and validation batches. 5 Review of scale up / exhibit documents – Scale up protocols, Reports, BMRs etc. 6 Should have good communication and writing skills and aware of Good Documentation Practices. 7 Should have well versed with SAP handling and Quality system software. Work Experience 2-4 years Education Masters in Pharmacy or Pharmaceutical T...

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

As a Quality Engineer at IRP Systems, you will play a crucial role in the development of high-performance e-powertrain systems that are set to revolutionize the electric vehicles market. We are looking for an experienced professional to join our team in India. Your responsibilities will include: - Building, managing, monitoring, and implementing Suppliers" quality plans and assessing their quality performance. - Conducting visits and audits at suppliers" sites to address questionnaires, FAI, and any managerial concerns. - Executing Supplier quality procedures, CAPA, SCAR & 8D, and preparing quality reports. - Leading the EMS quality activities to ensure compliance with IRP requirements. - Ov...

Dr. Reddys is looking for Manufacturing Scientists or senior scientists specialized in cell therapy (CAR-T) programs to join their Manufacturing facility team. As a Manufacturing Scientist, you will collaborate with Research and Product Development teams to support GMP Manufacturing operations, Technology transfer, quality assessments, and process validation of the CAR-T process for various Cell therapy programs. Your responsibilities will include designing and executing experiments to develop robust manufacturing processes for cell therapy products, leading and training a team of cell process scientists/engineers, managing T-cell culture and differentiation, documenting experimental procedu...

As a Senior QA Officer, your role will involve various responsibilities to ensure quality assurance within the API pharma industry. You will be tasked with issuing Batch Manufacturing Records, equipment cleaning records, logbooks, and analytical reports for raw materials, finished products, and packing materials. Additionally, you will assist in the preparation of SOPs for different departments and conduct plant rounds to verify documents according to cGMP and GLP norms. Line clearance activities for manufacturing and packaging, issuing deviation forms, change control forms, and handling customer complaints will also be part of your duties. You will review and verify analytical and Batch Man...

We are seeking a dedicated Senior Validation position at a reputed pharmaceutical organization based in Ahmedabad. Experience : 5+ Years Qualification : B.Pharma Role & responsibilities Thermal mapping for mixing/holding vessels, steam sterilizers (autoclaves), terminal sterilizers, depyrogenation tunnels, lyophilizers, filling machines, cold rooms, and cleanroom areas, Media fill Isolator and HVAC system ,Process validation and equipment Utility : compressed air, nitrogen, and steam quality testing. Change control, CAPA, and process understanding. Protocol, validation report, and SOP preparation , Cleaning validation. Interested candidate with the required qualification and experience are e...

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Data Warehouse ETL Testing Good to have skills : NA Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with team members to understand project needs, developing application features, and ensuring that the applications function seamlessly within the existing infrastructure. You will engage in problem-solving discussion...

Job Title: Assistant Manager In-Process Quality Assurance (IPQA) Department: Quality Assurance Location: Hyderabad, Jeedimetla Reporting To: Manager Quality Assurance / Head Quality Job Purpose: To ensure that all in-process operations are monitored and compliant with applicable cGMP, SOPs, and regulatory requirements. The IPQA Assistant Manager is responsible for in-line quality checks, deviation control, batch record review, and timely escalation of non-conformities during manufacturing and packaging processes. 1. In-Process Quality Monitoring Supervise and execute IPQA activities during manufacturing and packaging. Perform real-time line clearance, process checks, and verification. Ensure...

As a Manager Quality Assurance at Syngene International Ltd., you will be responsible for ensuring compliance with all national and international regulatory agency requirements related to API manufacturing. Your role will involve evaluating and approving vendors/subcontractors, reviewing and approving various reports such as SOP, analytical method validation, and calibration reports, and coordinating review meetings to maintain the effectiveness of the quality system. You will be expected to have a strong understanding of regulatory requirements from agencies such as ICH, USFDA, WHO Geneva, PMDA Japan, and others. Additionally, you will play a key role in the approval of protocols and report...

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your primary responsibilities will include: - Facilitating the harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. - Reviewing documents related to Quality Management System (QMS) & Compliance. - Ensuring compliance of the Quality Management System. - Participating in Site Training Programs as per site and Global Quality Standards requirements. - Submitting Dossier documents after review against requests received from Corporate regulatory affairs. - Responding to queries related to submitted dossiers as per requests from...

We are seeking a detail-oriented Deputy Manager Quality Assurance to support robust QA operations and also some Regulatory Affairs functions at Acharya Group's API manufacturing unit. This role focuses on maintaining our Quality Management System (QMS) for API production, ensuring cGMP and regulatory compliance for EU, USFDA, PMDA, and other Major Regulatory Regions. Key responsibilities include participating in batch release and continuous improvement; overseeing validation of API manufacturing processes, equipment, and analytical methods, managing deviations, conducting investigations, and implementing CAPA plans. Candidates must have prior experience in Quality Assurance within API manufa...

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 : NAMinimum 7.5 year(s) of experience is required Educational Qualification : BE 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 Integration Architects and Data Architects to ensure cohesive integration bet...