211 Pq Jobs - Page 2

About The Role Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NA Minimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will engage in the analysis and design of innovative business processes....

Role & responsibilities "• Execution of product/prototype testing in mechanical testing lab as per th e laid down SOP/WI , Protocols. • Execution of assigned product Testing. • Preparing specimens and samples. • Preparing the test equipment setup. • Understanding of the Standard Operating Procedure/Work Instruction, test Protocols/Reports. • Operate and maintain test equipment as per the requirements. • Keeps equipment operating by following operating instructions; troubleshooting breakdowns; maintaining supplies; performing preventive maintenance; calling for repairs. • Perform equipment qualification activities (IQ, OQ, PQ) • Perform equipment maintenance activities in DA lab, as applicabl...

Position Title: Project Engineer Department: Engineering / Projects Location: Chandigarh / Zirakpur (Can be posted abroad for ongoing projects) Reporting To: Head Projects Role Summary We are seeking an experienced Project Engineer with a background in Mechanical, Electrical, or Civil Engineering to join our project execution team. The ideal candidate will have 4–6 years of hands-on experience in project design and execution preferably within the pharmaceutical and biopharmaceutical industry. The role requires expertise in HVAC, mechanical systems, and automation, with working knowledge of CAD software for design and layout development. Key Responsibilities Lead and support the design, plann...

What you will do We are seeking a Business Systems Maintenance Lead to join our digital and sourcing technology team as an Information Systems Manager . This individual will be responsible for managing and coordinating the organizations information systems operations, overseeing deployments, and ensuring continuous improvement of digital tools. The role will require strong technical expertise, project management capabilities, and a passion for driving operational efficiency. This leader will play a critical role in supporting ERP and niche source-to-contract (S2C) systems, maintaining stability and performance, and enabling innovation through special projects such as GenAI implementations. R...

Role Description: We seek a skilled Sr. Associate Validation Analyst to oversee and manage validation activities for AI platforms and solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the AI products follow the required validation processes, documentation, and comply with Amgens standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: Plan, coordinate, and lead the execution of validation and change control activities, including qualification ...

Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgens Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issu...

Department Name: Enterprise Engineering and Analytics (EEA) Role GCF: 4 Job Family: Software Development Engineer-Test I I Role Description: We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgens standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & R...

What you will do In this vital role, you will support the qualification, validation, and compliance processes for SAP ERP solutions and related platforms. You will work closely with senior team members, Quality, and business partners to ensure validation deliverables are executed to meet industry standards and regulatory requirements in a Life Sciences environment. Roles & Responsibilities: Execute validation deliverables for SAP ERP systems (ECC, S/4HANA, BTP, GRC, and related platforms) in alignment with Amgens procedures and regulatory expectations. Support the creation, execution, and review of validation documentation (e.g., Validation Plan, Requirements, IQ, OQ, PQ/UAT test scripts, Tr...

Role Description: We seek a skilled Software Test engineer to develop, execute and maintain the test scripts for data platforms and custom-built solutions. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Front-end testing, Back-end testing, API testing, and test automation. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgens standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineeri...

Role & Responsibilities: Maintenance of all critical instruments present in QC laboratory. Perform the general preventive maintenance as per the procedure and frequency schedule to prevent breakdowns. Preparation and updating the General Preventive maintenance schedule as per the scheduled periods. Updating of the General Preventive maintenance activities and related log book entries. Coordinating with the outside service engineers for the IQ/OQ/PQ related activities and break down/repairs activities. Inventory and control of spares and consumables related to instrument maintenance. Maintaining Good Laboratory Practices. Maintaining Good Documentation Practices. Maintaining discipline in Lab...

Risk professional with proven ability to identify, assess, and mitigate operational risks across people, processes, and systems. Execute day-to-day operational risk and control management across functions. Conduct risk assessments, self-assessments, and ensure timely reporting. Track corrective actions, risk registers, and loss events with preventive action plans. Support implementation of risk programs (process, people, InfoSec, BCP, compliance, vendor & records management). Investigate incidents (fraud, security, data breaches) and identify fraud risk indicators. Analyze data for suspicious patterns and operational impacts. Drive stakeholder engagement, awareness sessions, and integration ...

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 ...

1) Ensuring their accounts comply with the requisite audit standards 2) Providing a robust and clear perspective to audit committees and 3) Providing critical information for stakeholders. Our Service Offerings include External Audit, Financial Accounting Advisory Services (FAAS), IFRS & US GAAP conversion, IPO and other public offering, Corporate Treasury - IFRS 9 accounting & implementation support etc. Your key responsibilities Experience of working on FS clients is preferred IT audits including statutory and internal audits IT General Controls (ITGC) testing IT Application Controls (ITAC) testing / IT Automated Business Controls testing IT Infrastructure risks and control assessments IT ...

Work on consulting projects for Banks, NBFCs, AMCs, Insurance companies, DFIs and other Government agencies and support the Senior team in execution Role would involve working on lending & digital transformation, system integrations, due diligence (technology & operations), process flow design & technology cost optimization Support in Business Development activity such as Preparation of RFPs, proposals etc. Develop analytical frameworks, create and present impactful PPTs/reports to drive client solutions

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 engineers in l...

Role Overview: As an Executive in the manufacturing department, your primary responsibility will be to supervise the manufacturing, processing, packaging, and holding of drug products according to approved procedures. You will also be in charge of maintaining the area and equipment in compliance with cGMP requirements. Additionally, you will be responsible for training subordinates on operational and cleaning procedures and coordinating IQ/OQ/PQ for new equipment/systems. Your role will involve following departmental SOPs for daily operations, handling material movement, and ensuring safety protocols are adhered to. Key Responsibilities: - Supervise manufacturing, processing, packaging, and ...

Job Description JOB DESCRIPTION (Executive) Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches. Maintaining the area and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition. To perform online documentation with respect to departmental procedures as per good documentation. To impart training of operation and cleaning related SOP to all subordinates and operators. Co-ordination for IQ / OQ for any new equipments / system. To perform PQ for any new equipments / system. To follow all concern departmental SOPs for day to day operation a...

About the Job The LEDP Release quality coordinator ensures adherence to Sanofi quality standards for each new release of the LEDP platform, including: Proper classification of new release (e.g. minor /major version) and adherence to related release process based on content. Right quality of documentation at each step of the development, testing and release process, as well as application support post release. LEDP is Sanofis backbone to new product development and industrialization. It establishes a data continuity between the CMC and Launch units. It enables paperless tech transfers and serves as a foundation for other digital tools such as Launch Readiness Control tower, One click TT, One ...

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...

Skill: CSV Manager Notice Period: Immediate . Employment Type: Contract Working Mode : Hybrid Job Description 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

About The Role Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NA Minimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will analyze and design new business processes to create the documentat...

As the leader of the DQA department, your role is to ensure the implementation of CGMP rules and regulations in Research & Development. Your responsibilities include: - Reviewing the Lab validation Protocol and Report of CRD. - Reviewing the Process Development report for DMF filing. - Reviewing the Specification and STP of Key Raw Material, In-Process, Intermediate stage, and Finished Product. - Reviewing the Method Development Report, Method Validation Protocol/Report, Method Transfer Protocol of ADL. - Reviewing the stability protocol and Report. - Preparing SOP, Formats / Annexures, Log books, and ensuring RA and GLP Compliance. - Interacting and communicating with R&D, ARD, QA, and Regu...

In this role as an Officer, your main responsibility will be to supervise the manufacturing, processing, packaging, and holding of drug products according to defined and approved procedures for stability batches and commercial batches. You will need to ensure that the area and equipment are maintained in an orderly manner as per cGMP requirements, in a good state of repair, and in a sanitized condition. It is essential for you to perform online documentation in adherence to departmental procedures and maintain good documentation practices. Additionally, you will be responsible for providing training on operation and cleaning-related SOPs to all subordinates and operators. Coordinating IQ / O...

As an Assistant Manager - Quality Control in the Production department at Sky Biotech, your role will involve providing quick and on-time results to the IPQC department. Your responsibilities will include handling all documentation work related to RM, IPQC, FP, stability samples, validation, etc. Additionally, you will be in charge of executing and reviewing instrument qualification (IQ, OQ, & PQ). **Key Responsibilities:** - Provide timely and accurate results to the IPQC department - Manage documentation tasks for various processes including RM, IPQC, FP, stability samples, and validation - Execute and review instrument qualification procedures (IQ, OQ, & PQ) **Qualifications Required:** -...

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team. The ideal candidate will have expertise in ServiceNow and HPALM. Roles and Responsibility Manage and implement CSV solutions using ServiceNow and HPALM. Collaborate with cross-functional teams to ensure seamless integration of CSV with other systems. Develop and maintain documentation for CSV processes and procedures. Troubleshoot and resolve issues related to CSV implementation. Provide training and support to end-users on CSV tools and features. Ensure compliance with industry standards and best practices for CSV management. Job Requirements Strong knowledge of ServiceNow and HPALM. Experience in managin...