679 Process Validation Jobs - Page 25

Glowria Lifecare Pvt. Ltd. is looking for QA Officer to join our dynamic team and embark on a rewarding career journey. Develop and implement quality control processes and procedures.Conduct audits of production processes and facilities to ensure compliance with regulations and quality standards.Develop and maintain documentation related to quality control activities.Investigate and resolve quality issues, working closely with production, engineering, and other departments.Develop and maintain product or service specifications, quality plans, and procedures.Monitor and analyze quality data to identify trends and opportunities for improvement.Train employees on quality control processes and p...

About Amgen Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning cultur...

Candidate should have experience on activities listed below but not limited to Scale up of process from Lab to Pilot to Commercial. Process validation of new molecules for regulatory filings Process validation of Cost Improvement Processes Yield and Capacity Improvement. Root Cause Analysis for OOS/OOT and Identification of appropriate CAPA Preparation of Investigation Reports. Process Hazard Analysis and Hazop studies preparation. Selection of Equipment Documentation related to Process Engineering activities like PFD, P&ID, Hazop, FMEA etc.. B. Tech , Chemical Engineering

Key Roles & Responsibilities: 1. Oversee and support the overall activities during the product development life cycle from quality perspective in R&D (API and intermediates). 2. To understand the site needs with respect to system establishment and sustainability. 3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions. 4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications & STPs, analytical method validation, method transfer, qualification, calibration, ...

Job Description Performing In-process Checks at different stages of manufacturing and packing stages for various products during validation activity and ensuring the compliance. Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification. Review of master batch manufacturing record and batch packing record in SAP. Active participation in execution of qualification and calibration activity. Ensure the compliance of the SOPs and cGMP requirements in Qualification and validation. Ensuring the compliance of the SOPs and cGMP requirements at shop floor. Work Experience 2 to 4 years Education Graduation in Pharmac...

Hi, We are hiring for ITES Company for Validation Associate Role. Job description ***Minimum 3 years as Validation Associate is required.*** 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation. 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through entry of the test data to the expected result...

Job Description 1 Master & Control of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records to concern departments. 2 Issuance of all documents like SOPs, BMR, Specification & MOA, logbooks ,calibration records to concern departments 3 Preparation of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records of concern departments 4 Reviewing of HPTLC, TLC, GC reports, peaks, graphs etc 5 Checking & signing of BMR of Liquid syrup, Tablets & Mother tincture section. 6 Receipt & storage of executed documents like BMR, Analytical logbooks, calibration records etc. 7 Receipt & storage of control samples of finished product, raw material etc. 8 Rec...

Job Summary : As a Quality Assurance (QA) professional with a qualification in MSc Chemistry, the primary role revolves around ensuring adherence to established quality and regulatory standards. The responsibilities cover a wide range of quality-related tasks, documentation management, and process validation activities in alignment with ISO and cGMP standards. Key Responsibilities: 1 Review and Implementation of ISO 9001 standards, Quality Management System Compliance, cGMP standards, ISO 14001, Halal & HACCP standards 2 Preparation of Certificate of Analysis, Good Receiving Note and other related documents in process QA checks. 3 Review of Purchase order coordination for dispatch activities...

Software Engineering Lead Analyst - HIH - Evernorth ABOUT EVERNORTH: Evernorthexists to elevate health for all, because we believe health is the starting point for human potential and progress. As champions for affordable, predictable, and simple health care,we solve the problems others don’t, won’t or can’t. Software Engineering Lead Analyst – SAP Integration Suite Position Overview We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position is right for you, we encourage you to apply! Our people make all the difference in our success. This area within Evern...

Kaliberr bioscience pvt ltd is looking for QA Executive to join our dynamic team and embark on a rewarding career journey You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)

Knowledge of Process development for APIs and intermediates/Trouble shooting of products at plant level/Planning and executing the experiments/Technology transfer to plant level/Handling reactions from mg to gram scale/ API R&D Required Candidate profile Cost reduction and plant troubleshooting/OD at plant site for technology transfer as & when required/ Chemistry/Regulatory Guidelines/GMP/GLP/ Timely delivery/ Compound interpretation NMR/LCMS/HPLC

Carry out solar resource assessment for various available resources based on the Project location Analysis of Energy Yield Numbers for various scenarios with different technology and optimizing the Plant Layout. Providing BOQ for the Project based on the AC & DC Cable Loss Calculation, Optimized Scenario. Evaluation of Module technology based on the documentation received from Module OEMs. Evaluation of Robotic Cleaning Solution technology based on the documentation received from Module OEMs. Plan Module Factory Visits for Inspection of the Module Manufacturing Process. Contribution to interface with Lender's Engineer and support Lenders due diligence. Working along with O&M Team to perform ...

To follow safety rules in the premises according to the company norms. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. Responsible for operation Maintenance and cleaning of External washing and Vial washing & Depyrogenation tunnel areas. Operation and cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Decartoning activity. Responsible for monthly frequency activity. Responsible for line clearance before start of the Activity. Preparation and periodic revision of SOPs related to respective area. Monitoring of DP, RH and temperature area in their respective area. To mai...

Responsibilities: * Ensure compliance with regulatory requirements through quality control measures * Conduct process validations, cleaning verifications & change controls * Prepare validation protocols & reports

Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality. Responsible for Review comments of MF, FMEA, RA protocol (Sampling plan, Process validation protocol) and compliance. Handling Support of Trouble shooting batches for data comparison and route cause Investigation at...

Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality. Responsible for Review comments of MF, FMEA, RA protocol (Sampling plan, Process validation protocol) and compliance. Handling Support of Trouble shooting batches for data comparison and route cause Investigation at...

Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality. Responsible for Review comments of MF, FMEA, RA protocol (Sampling plan, Process validation protocol) and compliance. Handling Support of Trouble shooting batches for data comparison and route cause Investigation at...

Ensure scientific assessmentinto the Manufacturability of the product for a robust process developmentduring new product introductions, product site transfers and processvalidation. Technical Support during process optimization activities related to ProductTransfer ProcessValidations. Technical input andknowledge sharing with team and Cross functional team (CFT). Root Cause Analysis, Statistical evaluationsand Trouble Shooting of existing commercial as well as site transfer products. Improving process capabilities, yields androbustness. Prepare, Review and Approval of technical documents like MFR, PORM, BMR,BPR, Risk assessment , protocols and reports for Trial batch, Hold timestudy, Stabili...

03 - 06 years experience of external preparations, Ointment and OSD IPQA activities Job Responsibilities - - Totrack batches for process validation, packing validation and hold time study. Certificationof Appropriate and timely Line-Clearance for Manufacturing, Packing, Dispensing Tocarry out the online checks& to take on line SAP entries. - ToWithdraw & Submit the Samples (Analysis SFG and FG & Control samples,Validation, Regulatory, R&D, Hold time study & Micro samples) toConcern Dept. as & when required. - Toensure the cGMP on the shop floor and to highlightthe on line Problems / Non Conformances with the respect to Procedures,Specifications, SOPs, cGMP etc. on day to day basis Numbers of...

As an Order Management Specialist, you will handle customer order intake, ensuring accurate product ordering (HW, SW, services) and initiating tasks like purchase orders, sales orders, invoices, and delivery notes. You will support procurement, distribution, invoice validation, and cash collection, resolving disputes when needed. Additionally, you will provide informal guidance to new team members. You have: 6+ years of relevant experience. Strong understanding of customer order intake and validation processes for hardware (HW), software (SW), and services. Proficiency in managing purchase orders, sales orders, invoices, delivery notes, and letters of credit. Experience coordinating procurem...

Dear Candidates, Greetings from KEYBIZ DASHBOARDS, We are looking for Quality Assurance Executive & Sr.Executive injectables&OSD for one of our reputed pharmaceutical client, based at Hyderabad & Vizag location. Please find below openings list. 1.IPQA 2.QMS 3.AQA 4.Validation 5.Equipment Qualification 6.CSV 7.Market Complaints. The above positions we are looking for Hyderabad & Vizag locations, interested please share us updated cv to prasanthi@mydashboards.in or feel free to call on 6305391924 Thanks and Regards Prasanthi - Dashboards Team HR

Preferred candidate profile Year of experience : 4 - 6 yrs Must have exposure on Review of documents MFR, BMR, BPR, QC specification, process validation data, stability summary report. Having exposure in licensing, Knowledge of GMP & GDP. Candidate must have exposure in regulatory market. Interested candidate may share resume at hr.plant@zuventus.com

Ensuring annual budget plan adherence of all administrative related services to the entire factory Ensuring availability of infrastructure related services like workstation, computer/ laptop, intercom, mobile connection, etc. to all employees Ensuring adherence to norms and policies in terms of new joining facilities like payment for shifting, allotment of car with respect to companys car policies, etc Ensuring smooth joining process of new employee by providing him/her all the services entitled to him according to his grade and the policy Ensuring proper management of travel related services to all employees in terms of local taxi, flight, bus, train, hotel, guest house bookings, etc Ensuri...

Candidate should have experience on activities listed below but not limited to Scale up of process from Lab to Pilot to Commercial. Process validation of new molecules for regulatory filings Process validation of Cost Improvement Processes Yield and Capacity Improvement. Root Cause Analysis for OOS/OOT and Identification of appropriate CAPA Preparation of Investigation Reports. Process Hazard Analysis and Hazop studies preparation. Selection of Equipment Documentation related to Process Engineering activities like PFD, PID, Hazop, FMEA etc. . B. Tech , Chemical Engineering

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