212 Qualification Jobs - Page 4

As an Analytical Development Scientist at our company, your role involves conducting departmental operations efficiently, maintaining laboratory areas to meet quality and safety requirements, providing training and support to production and QC groups, engaging in compliance projects, and identifying opportunities for cost reduction and waste minimization. You will also be responsible for ensuring timely completion of project deliverables, leading aspects of projects, planning and carrying out work in line with customer requirements, and providing project support for method development and validation activities. Key Responsibilities: - Perform assigned work as agreed with the project lead and...

**Job Description:** As a Process Engineer, your role involves reviewing the process flow according to customer requirements and developing process flows for pharmaceutical formulations. You will work closely with the project manager to conduct capacity and cycle time analysis, define equipment sizing, and create technical specifications (TS) and data sheets for production, packaging, and process equipment. Your responsibilities will also include floating inquiries to vendors, resolving technical queries, and following up with vendors for offers. Additionally, you will organize meetings with vendors, create a make/vendor list of production machinery within the project budget, and participate...

**Job Description:** As a Client Relationship Management professional, you will be responsible for building and maintaining strong relationships with existing and potential clients. Your role involves fostering a positive rapport with clients to enhance business opportunities. **Key Responsibilities:** - Develop and implement sales strategies to achieve company goals effectively. - Identify and qualify leads through various channels such as networking, cold calling, and industry events. - Present products or services to clients in a compelling manner, tailoring presentations to address their specific needs. - Negotiate contracts and agreements to secure profitable deals for the company. - Ma...

Handling of QMS activities (CCF, Deviations and OOS etc.) Preparation and review of SOPs, EOPs, OCPs, BMR and production related documents. Review of batch reports and Involvements on productivity improvements and batch failure investigations. Preparation of AIM and HIRA register. Preparation of HAZOP study. To coordinate with QA for all the validation, qualification, and Audit preparedness. Adherence to Standard Operating Procedures, product specifications. Adherence to Good manufacturing Practices and Good Documentation Practices. Review All completed documents and ensuring that completeness and signed. Real time data entry in Quality records. Handling of e-BMR (SAP) activities. Sound know...

What You'll Do The candidate in this position is responsible to - Drive and execute New Product Design and Development, VAVE, B&P, and Sustaining Engineering through Eaton PROLaunch / PreLaunch / ACES Engineering processes and CI mindset Create Product Concepts & Architecture ideas and demonstrate, expertise at STEM - Science Technology Engineering Mathematics basics for demonstrating the feasibility of designs through relevant Engineering calculations/predictions Has proficiency with CAD, Analytical Tools (CATIA, CREO, AutoCAD, MathCAD, Matlab/Simulink, CfX, ADL, etc.), Limits, Fits & Tolerancing, GD&T Apply basics of DfX - DFSS, DFMA, DfR, and DFE. Apply Robust design methodologies/tools f...

Roles and Responsibilities To be handle all API pharma equipment w.r.t. manufacturing. Perform operation related activities. Ensure compliance with regulatory requirements. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Maintain accurate records, reports, and documentation. Desired Candidate Profile having experience in API pharma industries. Strong understanding of Good Manufacturing Practices (GMP) regulations. Experience with Cleaning Validation & Equipment Qualification procedures.

Validation Master Plan (VMP): Lead the preparation, review, and maintenance of the Validation Master Plan (VMP) to ensure alignment with industry standards and regulatory requirements. Qualification/Validation Protocols: Review and approve Qualification/Validation protocols to ensure they comply with CGMP standards and regulatory requirements. Quality Systems Maintenance: Ensure all quality systems are maintained according to CGMP requirements and monitor compliance across all departments. SOP Review & Approval: Review and approve Quality Assurance (QA) SOPs as well as SOPs from cross-functional departments to ensure consistency and regulatory compliance. Document Review & Compliance: Review...

Validation Master Plan (VMP): Lead the preparation, review, and maintenance of the Validation Master Plan (VMP) to ensure alignment with industry standards and regulatory requirements. Qualification/Validation Protocols: Review and approve Qualification/Validation protocols to ensure they comply with CGMP standards and regulatory requirements. Quality Systems Maintenance: Ensure all quality systems are maintained according to CGMP requirements and monitor compliance across all departments. SOP Review & Approval: Review and approve Quality Assurance (QA) SOPs as well as SOPs from cross-functional departments to ensure consistency and regulatory compliance. Document Review & Compliance: Review...

SOP Adherence & Training: Perform all activities in strict accordance with the current version of SOPs and ensure all tasks are executed as per established training curriculums. Schedule and conduct on-the-job training for new departmental employees as a trainer and training coordinator, ensuring practical technical staff training. Manufacturing Management: Oversee and manage daily manufacturing activities and manpower, ensuring consistent batch manufacturing to keep theoretical yields within established limits. Participate directly in batch activities, performing tasks according to Batch Manufacturing Record (BMR) instructions. Equipment & System Management: Lead and participate in equipmen...

Role Overview: As a Proposal and Contracting Specialist at Infosys, your primary responsibility will be to drive proposal negotiation and closure with external clients. You will facilitate proposal coaching sessions between the client and pursuit teams, ensuring the articulation of business value and driving pricing to win deals at the right premium. Additionally, you will play a crucial role in contracting and MSA discussions to ensure quick closure of contracts with an acceptable level of risk to Infosys. Account planning and review will also be a key aspect of your role, including developing account plans, relationship maps, and conducting periodic reviews with higher management to grow a...

Role Overview: As a Sales Development Representative (SDR) at Unbound B2B, you will play a crucial role in driving sales efforts and generating new business opportunities. You will prospect, qualify, and nurture leads to create high-quality sales opportunities for Global Account Directors. Key Responsibilities: - Prospecting: Identify and research potential clients through various channels such as cold calling, email campaigns, and social media to generate interest in solutions. - Qualification: Engage with prospects to understand their business needs and qualify them based on the ideal customer profile. - Lead Nurturing: Develop relationships with prospects through ongoing communication to ...

As the Utility Systems Manager in injectable facilities, your primary role will involve overseeing operations, ensuring compliance with regulations, and implementing efficient facility management practices. You will lead the execution of greenfield/brownfield injectable facility projects, from design to qualification, including tasks like budgeting, procurement, construction, and commissioning. Your responsibilities will also include overseeing critical utility systems like WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems to ensure smooth operation and compliance with standards. Key Responsibilities: - Manage greenfield/brownfield facility projects from start ...

Role Overview: You will be responsible for leading end-to-end execution of greenfield/brownfield injectable facility projects. This includes covering design, budgeting, procurement, construction, commissioning, and qualification. Your main focus will be on ensuring uninterrupted and compliant operation of critical utilities such as WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems. Key Responsibilities: - Ensure all systems and documentation meet cGMP, GEP, and regulatory standards like USFDA, EU-GMP, WHO-GMP. - Prepare for and support audits and inspections, collaborating with QA, Production, Validation, and EHS teams. - Manage third-party vendors, consultants...

As a Senior Process Engineer at Jacobs, your role involves contributing to the efficient and compliant delivery of process engineering design on projects. You will work closely with Project Managers/ Process Engineering Manager to ensure quality technical design output, technical governance, and coordination within a multi-discipline project team. Your responsibilities include: - Leading process engineering design activities for Energy and Industrial projects, from Basic, FEED to detailed engineering. - Conducting process simulations, heat and material balances, and equipment sizing for optimal process designs. - Performing process safety studies such as HAZOP, SIL, and PHA to identify and m...

As a member of the Technical Operations team at Azurity Pharmaceuticals, you will play a crucial role in managing and overseeing technical process strategy, CMO and CDMO management, and the execution of product deliverables. Your dedication and expertise will contribute to the success of Azurity in providing innovative products to underserved patients. Here are the key responsibilities and qualifications required for this role: **Key Responsibilities:** - Manage the planning and execution of manufacturing for both development and commercial products, including qualification and validation activities. - Develop, review, and approve controlled documentation related to late-stage development, q...

As a Specialist Business Development Representative for Enterprise at Adobe, your role involves lead generation and qualification to drive business growth. **Key Responsibilities:** - Generate and qualify leads to contribute to the growth of the enterprise business segment. **Qualifications Required:** - Previous experience in business development or sales. - Strong communication and interpersonal skills. - Ability to work effectively in a fast-paced environment. At Adobe, you will experience an exceptional work environment renowned globally. You will have the opportunity to engage with colleagues who are dedicated to mutual growth through continuous feedback. If you are seeking to create an...

As a Commissioning and Qualification Engineer for Pharmaceutical equipment, your role will involve working with a range of equipment including RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators, RABs, GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. You will be responsible for developing various protocols such as CQMP, VMP, FRA, cGMP review sheet, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. In addition, you will execute Commissioning, qualification, and validation activities for Pharma Process Equ...

As a Sr. Officer/Executive, your role will involve the following responsibilities: - Execution of installation & commissioning of equipment. - Qualification, preparation, and qualification of equipment. - Various project executions as per organization requirement. - Maintenance and breakdown activity related to plant equipment/machineries. - Performing preventive maintenance activity of plant machinery as per PM schedule and respective SOP. - Assisting engineer in installation & commissioning of plant machinery. - Generating tools and parts requirement for daily breakdown and preventive maintenance. - Immediate intimation to the superior for critical breakdown. - Reporting daily breakdown an...

As a Computer System Validation & QA-IT professional, your role involves various responsibilities related to process activities. Some of the key responsibilities include: - Reviewing Qualification and Re-Qualification protocols & reports. - Reviewing Preventive Maintenance & Calibration records. - Reviewing and approving critical consumable items. - Monitoring engineering & utility services such as facility layouts, building layout, material flow, HVACs, Nitrogen plant generation and distribution, purified water generation and distribution, and Equipment qualification. - Reviewing breakdown maintenance system. - Handling SAP activities for Engineering. - Managing new product introduction at ...

Preferred candidate profile Candidate must be from API/Bulk Drugs/ Chemical Industry. Role & responsibilities Quality System Management: Develop, implement, and maintain quality assurance policies and procedures in line with cGMP, ISO, and other relevant regulatory standards. Team Leadership & Mentoring: Lead, manage, and train the QA team, fostering a culture of quality and continuous improvement. Process & Product Quality: Oversee quality testing activities, analyze quality trends, identify non-conformities, and ensure the final API product meets high-quality standards. Supplier Quality Management: Provide Quality oversight of external vendors, assess supplier qualifications, and manage AP...

Preparation and review Protocol & Report of cleaning validation/verification. Planning, Communication and Execution of Cleaning validation activity. Planning communication and review for new products process performance qualification (PPQ). Planning communication and review for Hold time study of new products. Preparation and execute the Hold time study for clean equipment's, dirty equipment's and campaign products. Assessment of New product and new equipment for cleaning validation. Conducting Risk Assessments of new equipments and products. Design and create validation protocols & reports for cleaning validation, process validation, media fills & air system qualifications To perform Factor...

Develop and implement a strategic vision for the QA function aligned with the company's overall business goals. Provide leadership and direction to the QA team, ensuring a consistent and integrated approach to quality management. Develop, implement, manage, audit and maintain GMP quality systems. Coordinate and perform all vendor qualification and compliance Should have well versed with handling of Regulatory Audits, APQR, OOS, OOT, Investigation, Laboratory Compliances, HVAC & Water Qualification & Validation, IPQA, Lab QA, Validation & Qualification and QMS. Develop, manage and maintain a GMP compliant document control system. Oversee investigations of all non-conformances (deviations, err...

As an experienced candidate with 2-5 years of experience, your role will primarily involve transistor level circuit design tasks such as critical path modeling. You will be responsible for designing and qualifying memory components like bit cells, sense amplifiers, and read/write circuitry. Additionally, you will be involved in the characterization and qualification of various memory components such as SRAM, RAMS, Register Files, and cad view generations. Qualifications Required: - 2-5 years of relevant experience in transistor level circuit design - Proficiency in critical path modeling - Experience in designing and qualifying memory components - Knowledge of characterization and qualificat...

In this role at Apple, you will have the opportunity to partner with multi-functional teams to evaluate design and processes at the concept phase. Your responsibilities will include developing measurement technologies, control strategies, information systems, and manufacturing methods that achieve ambitious specifications at massive production scale. Additionally, you will develop and implement groundbreaking quality inspection tools to evaluate cosmetic and dimensional part characteristics. Your role will involve compiling and evaluating data to determine appropriate limits and variables for process and part specifications. You will lead activities to balance unparalleled quality with scala...

Role Overview: As a Business Development Associate (BDA) at our company, your primary responsibility will be reaching out to prospects and guiding them through the existing tech-landscape. With a customer-centric approach, you will qualify their career goals and identify how Scaler can help them. It will be your duty to follow up with existing prospects to ensure that we are able to open up new realms of possibilities through the power of Scaler! Key Responsibilities: - Reach out to prospects and guide them through the existing tech-landscape. - Qualify prospects" career goals and identify how Scaler can help them. - Follow up with existing prospects to open up new realms of possibilities. Q...