253 Oq Jobs - Page 6

Role & responsibilities : Perform fogging and VHP generator operations for bio-decontamination services. Handle validation and installation of decontamination equipment, generators, and foggers. Execute cleanroom validation processes specific to fogging and VHP systems. Conduct and document GDP qualification activities - IQ, OQ, PQ Troubleshoot and resolve breakdown activities for fogging/VHP systems. Carry out Preventive Maintenance (PM) and calibration of fogging and VHP generators. Ensure compliance with pharma production requirements and cleanroom practices. Maintain accurate documentation in line with GDP/GMP standards. Travel to client sites across multiple locations as required. Candi...

Educational Requirements Master of Pharmacy,Master Of Technology,Bachelor of Pharmacy (Honors),Bachelor Of Science,Bachelor of Engineering,Bachelor Of Technology Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS...

Job description Responsibilities: Qualify suppliers according to company standards & management of approved supplier list per purchasing control compliance. Initiate and drives SCAPAs/NCRs to suppliers not performing/or adhering to company standards. Manage supplier change requests . Assess supplier performance on periodic basis & drive necessary action for continous improvement. Establish a process & ensures that suppliers deliver quality parts, materials, and services. Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ & PQ methodology. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves sup...

You will proactively assess quality issues and ensure compliance to QA/QC as per regulatory requirements in manufacturing operations and quality function at the site by keeping track of quality metrics. You will ensure the site is always ready for regulatory/statutory inspections/internal audits and regularly monitor the performance of each individual in the Quality department. You will facilitate internal and regulatory agency audits, ensuring findings from site audits are understood, assessed, and addressed comprehensively. Moreover, you will ensure the closure of audit observations by reviewing the CAPA and driving its implementation. Implementation of requisite changes at the plant level...

Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Contribute actively to release planning and estimate test efforts Test in an Agile development environment, analyze and communicate test results to team and manager Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), Validation Reports, deviations, change control, and non-conformance management. Assist with UAT, test data pre...

Roles & Responsibilities: Work on validation and testing of web-based applications, specifically the 3DEXPERIENCE platform. Perform various types of testing such as functional, system, stress, performance, integration, regression, and beta testing. Develop and maintain detailed test plans for 3DEXPERIENCE modules and applications. Lead, mentor, and coach junior quality and validation engineers on test execution and documentation. Analyze test results, identify issues, and work collaboratively with product teams and Dassault Systemes for resolution. Prepare validation documentation including validation plans, IQ/OQ/PQ protocols, validation reports, deviations, change control, and non-conforma...

As a Senior Engineer in Plant Engineering at Dr. Reddys Laboratories Ltd., you will play a crucial role in ensuring adherence to Operations & Maintenance SOPs, schedules, and compliances to prevent breakdowns. Your responsibilities will include the installation and qualification of equipment, preparation and execution of various protocols and reports, breakdown and preventive maintenance of a wide range of equipment, PR initiation and vendor management for AMC equipment. Additionally, you will be in charge of executing infrastructure projects related to electrical requirements, overseeing project activities for quality, delivery, timelines, and safety, and ensuring zero incidents through com...

You will be part of a greenfield project located in GIDC Vapi, covering an area of 10,556 sq m dedicated to the manufacturing of Pharma Intermediates and APIs. The project is designed to include a main intermediate production building, a GMP facility, and infrastructure for Catalytic Hydrogenation, emphasizing sustainable practices and competitive innovation. Your responsibilities will involve the preparation and upkeep of Engineering/Project documentation, Qualification & Validation documents throughout the various stages of the greenfield project until commercial manufacturing. It is essential to ensure the implementation and adherence to industry/cGMP best practices. This includes creatin...

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, repo...

Execution of IQ, OQ and PQ for new equipment, facility & utility system, report preparation and maintenance of record. Execution of Periodic performance verification activities for equipments, facility, utilities and its report preparation. Review Initial qualification master document like URS, GxP assessment, DQ, FAT, SAT, IQ, OQ, PQ and PPV of EFU system and all executed report. Handling of departmental QMS activity through track wise software, discrepancy / deficiency activity compliance of observation, summary preparation for regulatory submission. Qualification and Periodic performance verification activity execution, compilation, review of reports [Filter integrity test (PAO), air velo...

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

Handle Pre - FAT & FAT. Will visit the sites if required. To guide and support Operation at QA/QC team. To communicate with customer . Responsible for inter departmental communication. To Face Internal & external audits. Write technical reports. Provident fund Annual bonus Office cab/shuttle

work experience in field service engineer for pharma Machines. • Hands on experience IQ,OQ,PQ trails and documentation. • Work experience on installation, maintenance, calibration. • Hands on experience for analytical instruments. : Required Candidate profile Bottle packing line & Imprint machines.Dry granulation (Roll compactor). Inspection machine (Viswill inspection).•Work experience on spares & AMC revenue generation.Work experience on calibration :

IQ, OQ and PQ,execution of Facility, Utility, Equipment and Computer system qualification,Client schedules,Report daily activities and work completion status to Sr. Manager, Validation ,SOPs Validation, Qualification,Calibration activities

Roles and Responsibilities Ensure compliance with GLP guidelines, including investigation of OOS/OOT events and vendor qualification. Maintain accurate records of GLP documents, instruments, and equipment through preventive maintenance schedules. Conduct calibrations on instruments according to CGMP requirements and perform spares management tasks. Implement LIMS system for effective inventory control and HPLC analysis. Perform CAPA activities as needed to resolve quality issues. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Organic Chemistry from a recognized university. Minimum 10-15 years of experience in pharmaceutical industry with expertise in GLP practices. Strong ...

Major Purpose of the Job: (Exactly spell out key deliveries/results expected from this job) Person should have minimum 12+ years of experience in SAP-PP, SAP-QM, SAP-PM modules Should have implementation experience of S4HANA (Minimum one project) Ensuring Smooth Functioning of SAP-PP/QM/PM modules. To Provide Support in SAP-PP/QM/PM modules for all companies of Cadila. This will include SAP-PP/QM/PM module configuration also. Principal Accountability: (Please write all the major jobs that the employee is required to carry out ) Supporting users in Day to day issues in SAP-PP/QM/PM modules for all companies of Cadila. Knowledge on Product costing (Production order/Process order), MRP, Order e...

Title: Instrumentation and Automation Engineer Qualification: B.E in Electrical & Instrumentation Primary Responsibilities: 1. To attend /or supervise all jobs related to Instrumentation Engineering activities in site. 2. Timely execution of all calibrations of equipments/instruments as per schedule coordination with user. 3. To attend emergency breakdowns of all plant wide machines round the clock as and when required. 4. Maintain the Spare parts of all critical Instruments in site. 5. Timely execution and completion of Validation activities to be done in site. 6. Execution of all In-house Projects in instrumentation and automation in site. 7. Maintain the calibration logs, area /equipment ...

The Documentation Engineer will be a key member of the execution team, responsible for managing and maintaining documentation related to installation, commissioning, qualification of process and utility equipment

Execution & documentation of cleaning validation Protocol review IQ/OQ/PQ Swab & rinse sampling Regulatory audit support Coordination with cross-functional teams

Roles and Responsibility Develop and implement comprehensive test plans to ensure high-quality software products. Collaborate with cross-functional teams to identify and prioritize testing requirements. Design and execute automated tests using various tools and technologies. Analyze and report defects found during testing, working with development teams to resolve issues. Participate in agile development methodologies, providing feedback on product quality and suggesting improvements. Stay up-to-date with industry trends and emerging technologies in QA engineering. Job Requirements Strong understanding of software testing principles, methodologies, and best practices. Experience with automat...

Hiring for the role of Documentation Job Title: Documentation Level Executive / Sr. Executive Experience: 3-5 Years Location: Ankleshwar Job Summary: The Documentation Engineer will be a key member of the execution team, responsible for managing and maintaining documentation related to installation, commissioning, and qualification of process and utility equipment. This role is ideal for mid-level professionals (3-5 years of experience) looking to advance their expertise in installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for equipment used in pharmaceutical, chemical, and food processing industries. Key Responsibilities: Prepare and maintai...

Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessmen...

EXIM: Manage documentation retention of all commercial documents for North America shipments. Follow up for missing documents from all vendors in a timely manner to prevent logistics delays. Goods Receipt of 3rd party invoices in SAP Verification of commercial invoices as per US Customs entries Export Planning & operation. Sales order-Purchase Order Support Sales by managing customer orders, creation of Sales order-Purchase order (SOPO). Coordination with Sales team, inventory team & Planning team to analyze & place order as per business requirement. Support marketing in implementing customer complaints resolution. Creating Standard reports on Open Orders, closed order & Inventory availabili...

As an Electrician Diploma at Surmount Laboratories Pvt. Ltd., you are expected to have a minimum of 2 to 5 years of experience with a strong understanding of HU DY System Knowledge. Your responsibilities will include pre-balancing, filter cleaning work, documentation work, as well as knowledge in IQ, OQ, PQ, DQ HVAC Qualification. Additionally, you will be responsible for preventive maintenance documentation and general documents related to the field.,

Job Description :- Maintenance Officer / Sr. Officer Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing ...