449 Process Validation Jobs - Page 2

As a Metallurgist at our company, your main responsibilities will include: - Overseeing material analysis and testing operations, which involves conducting chemical analysis, performing mechanical testing, and analyzing microstructure using the laboratory's equipment suite. You will be responsible for maintaining testing accuracy and ensuring proper calibration of all equipment. - Validating heat treatment processes through Jominy end quench testing and hardness profiling, and establishing correlations between hardenability data and production results. This will entail monitoring process parameters and recommending adjustments based on test results. - Conducting comprehensive quality control...

As a QA (Quality Assurance) /Test Developer you will be designing better ways to identify potential weak spots, inefficiencies, and issues within software systems. This position will work closely with development teams and other test engineers in the implementation and delivery of software products that meet rigorous quality standards, budgets, and timelines. The role seeks good levels of personal organization, and the ability to work well with a distributed global team in a fast paced and exciting environment. You will play a key role by delivering quality functions for development teams within test driven framework. Your scope will include Test Plan Development, Test Case Execution, Automa...

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma. Job Summary Coordinate with concerned department for monitoring /tracking of change control for its effective implementation and clouser of Change controlin an timely manner. Job Responsibilities Review of the MBPCRs and MGCRsfollowed by change control impact asses...

Key Expected Skills: Must have an Experience in Process Quality Should have experience in product inspection and process validation, preferably from electronics industry with exposure in SMT & assembly in QA dept Expertise in instrument handling, QMS, RoHS, UL, IPC Workmanship standard, PFMEA, SPC, MSA, Poka-Yoke, Kaizen & 7QC tools Must have knowledge of ESD 20:20 standard, IATF standard. Desirable Candidates: Diploma/Bachelors degree in ECE/EEE with 2+ years of experience, preferably from Electronics manufacturing industry Should have experience in PPAP Documentation Willing to be open for Face - to - Face Interview in Pune If You are interested, Contact Deviga Junior Executive - Talent Se...

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...