278 Pq Jobs - Page 7

Role & responsibilities .Department - Production (Fill-Finish) Jr. Operator / Operator / Sr. Operator Job Description: Depyrogenation, HPHV Steam Sterilizer, Production related activities, Lyophilizer, Vial filling & Sealing machine operations & Formulation activities Experience: 1 - 6 years Qualification: ITI/Diploma/B. Sc/Equivalent Job Description: Officer / Executive /Jr Executive Production plan, filling activities, cGMP, SOP, Preventive maintenance, Lyophilizer, Aseptic Media fills, HPHV, Handling Filter integrities, DQ, IQ, PQ, OQ. Experience: 1 - 6 years Qualification B. Pharmacy / M. Pharmacy What should you carry 1. Updated resume 2. Latest increment letter with last three months p...

Job Characteristics: Leads software development projects through the phase gate process. Leads requirements gathering efforts of the software team to ensure that customer and divisional needs are met. Manages interactions between team & stakeholders to ensure seamless project integration. Writes code to address challenging aspects of the project. Writes the standard documentation used to translate project needs into software design specifications. Assists in creating overall architecture for various software systems. Corrects challenging defects found through QA software testing and systems testing. Supports field test personnel after development with issues not addressed by software enginee...

Ensure accurate and timely processing of invoices and monitor incoming payments. Manage and oversee the daily operations of the AR department including invoice processing, payment processing, and account reconciliation. Knowledge of TDS & GST. Secure revenue by verifying and posting receipts and resolving any discrepancies. Maintain accurate records and control reports for all AR transactions. Use accounting software and MS Excel to process business transactions and compile reports. Collaborate with other departments to ensure billing accuracy. Address and respond to customer inquiries regarding invoices and payments. Ensure compliance with accounting principles and company procedures. Parti...

Job Title: CQV Engineer Location: Bangalore Experience: 3-4 years in pharma CQV 1. Commissioning Activities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. 2. Qualification and Validation: Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WH...

Skill Required Roles and Responsibilites 1. Media fill and qualification summary preparation knowledge. 2. To maintain track of qualification and validation activities. 3. To prepare and review the protocols and reports. Execution of various qualification / validation activities. 4. To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT). 5. Co-ordinate with production and other user department for qualification/validation activities 6. Timely compile and review of qualification validation reports. 7. To review the equipment documents like calibration reports and ensure correctness of documents. 8. To perform FAT. 9. To co-ordinate with outside agencies ...

As a Process Incharge - Injectable, you will be responsible for overseeing formulation manufacturing projects with an experience requirement of 12-15+ years, including 5-6 years specifically in formulation manufacturing projects. Your key responsibilities will include reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval when necessary. You will be tasked with verifying process equipment instruments in alignment with PI&D and electrical drawings, ensuring commissioning of instruments as needed, and conducting Factory Acceptance Tests (FAT) for process equipment where necessary. Additionally, you will provide support for installat...

The Document Controller position at SEPAM in Chennai is a full-time on-site role that involves managing project documentation, records, and communication tasks related to document management. The ideal candidate should possess hands-on experience in GMP, Equipment Qualification, DQ/IQ/OQ/PQ, as well as experience in FMCG projects. Key responsibilities include document management, project documentation, and records management. The successful candidate will need to demonstrate strong communication skills, attention to detail, and organizational skills. Proficiency in document control software is essential for this role. Additionally, the ability to work effectively in a team environment is cru...

You will be responsible for leading the execution of the SICR strategy at our organization by building and nurturing a highly capable and scalable team. Your role will involve challenging divisional processes to drive high-yield, cross-divisional outcomes. In addition, you will drive thorough SICR scrubbing to capture all relevant details, challenge suppliers, and maximize service, quality, and cost benefits. Coaching and developing subject matter champions to actively shape process improvements and ensure compliance with Stryker procedures will also be a key aspect of your responsibilities. Regularly reviewing SICR aging reports, collaborating with sourcing to cancel or deny cases with obso...

You will be responsible for documentation and execution of qualification activities. This includes preparation, review, and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ (Requirement Qualification) documents. Your responsibilities include the review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems. You will be responsible for new project-related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). You will review and co...

• Execute product/prototype testing as per SOP/WI and protocols. • Prepare specimens, samples, and test equipment setup. Record, interpret, and analyze data; prepare test reports. Required Candidate profile Operate and maintain lab equipment; perform calibration and maintenance activities. Ensure strict compliance with safety procedures, GLP, GDP, and 5S standards

As an experienced professional with over 10 years of expertise in Lab Vantage LIMS, you will be proficient in working with tools such as bartender, executing SQL queries, and managing CSV deliverables. Your role will involve conducting CSV activities including IQ, OQ, and PQ, while gaining hands-on experience in SaaS environments, with a preference for Lab Vantage. Responsibilities: - Working on bartender - Executing SQL queries - Managing CSV deliverables - Conducting CSV activities such as IQ, OQ, and PQ - Gaining hands-on experience in SaaS environments Qualifications: - Experience with Lab Vantage LIMS Required Skills: - Good knowledge of CSV deliverables - Good knowledge of CSV activiti...

Job Characteristics: Leads software development projects through the phase gate process. Leads requirements gathering efforts of the software team to ensure that customer and divisional needs are met. Manages interactions between team & stakeholders to ensure seamless project integration. Writes code to address challenging aspects of the project. Writes the standard documentation used to translate project needs into software design specifications. Assists in creating overall architecture for various software systems. Corrects challenging defects found through QA software testing and systems testing. Supports field test personnel after development with issues not addressed by software enginee...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : SAP FI CO Finance Good to have skills : NAMinimum 5 year(s) of experience is required 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 various teams to understand their needs, developing solutions, and ensuring that applications function effectively to support business operations. You will engage in problem-solving and decisi...

Position : Executive Engineering QMS Qualification : BE Mechanical/ Electrical/ Instrumentation or B pharma preferably BE Experience : 6-7 years experience in handling engineering department GMP documentation activities and supporting engineering function as SME in QMS documentation Responsibilities : 1.Implementation of quality assurance standards, processes, controls and cGMP in warehouse. 2. Preparation of SOPs and ensure effective implementation. 3. should be well versed with deviation management SOP 4. Should be well versed with change control and CAPA management related to engineering department 5. Should be familiar with documentation like DQ, IQ, OQ and PQ. 6. To ensure that training...

• IT Infrastructure Management: Overseeing the management of IT and OT infrastructure, including hardware, software, networks, and data centers. Ensuring the availability, reliability, and security of IT systems. Ensuring minimal downtime and optimal performance. • System Performance: Ensure the reliability and availability of IT and OT systems and applications critical to manufacturing processes as per business requirements. • Security and Compliance: Ensure IT and OT systems and processes comply with industry regulations and standards, such as FDA, EMA, and GMP. • Disaster Recovery: Develop and maintain disaster recovery and business continuity plans to minimize downtime and data loss in c...

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 Bid Manager at Eazy ERP Technologies, you will be responsible for assembling and managing a bid team to prepare and submit winning bids. Your role includes managing opportunities from initial customer requirement identification to contract renewal. You will introduce and implement bid procedures, governance, and processes, requiring strong people management and commercial skills. With 3 to 6 years of experience in Bid management from an IT Company, you will manage the end-to-end bid process, understand PQ, TQ, and commercial requirements, and prepare responses on PQ, TQ, and commercials in all formats and annexures. Your expertise in operating procurement portals, DSC, proposal writing,...

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...