418 Gxp Jobs - Page 11

PolyPeptide is on a transformative growth journey expanding globally, investing in new technologies, and increasing our production capacity through major site expansions and strategic projects, As part of this, we are launching a global SAP S/4HANA implementation to modernize and harmonize how we work across sites, systems, and teams This is a greenfield initiative and a truly unique opportunity to join from the very beginning and help build the ERP function that will support PolyPeptides operations for years to come, As the Head of ERP, youll take the lead in shaping and delivering this enterprise-wide ERP foundation Youll be a key player in driving digital transformation across the organiz...

I nviting applications for the role of Principal Consultant CSV Analyst In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. Responsibilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop CFR Part 11 computer systems validation plans, qualifications test p...

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...

Job Role: Supplier Quality Engineer Duration: 3 months contract Top 3 skills are: Experience with maintaining supplier qualification documentation within GxP systems Experience in creating and maintaining data reports for Supplier Quality function Proficient in Microsoft Excel. Requirements: Minimum 3 years of work experience, preferably in Quality within Pharmaceutical, Life Sciences, Medical Devices, or similar industry Bachelor's degree required Data administrative support for the Global Supplier Quality team including: Maintain weekly Supplier Quality data report in SharePoint Create and/or maintain Supplier Quality reports including monthly KPI bowler, quarterly PO/QSL report, etc. in S...

GxP, GLP, regulatory environments Support Analyst Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applications supporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validat...

The Technical Architect will have to be execution-focused, supporting the full implementation lifecycle, from scoping to deployment in an evolving ecosystem consisting of clients and partners. You will be responsible for successfully solutioning the enterprise application E2E, designing and building the Salesforce Industry-specific Life Sciences, Health industry solutions. As a Technical Architect, you will become a deep product expert with Industry Salesforce Life Sciences Cloud (including Health Cloud) applications, and work closely with our sales and delivery teams to ensure customer success. You will lead the technical design and implementation of Salesforce solutions, ensuring complianc...

As a Solution Architect-SAP Production Planning at Percipere, you will be responsible for designing, building, and optimizing end-to-end SAP Manufacturing Processes for our customers" enterprise. You will lead large-scale transformation projects in the Manufacturing Workstream, leveraging your experience, including PP object data migration experience in S/4 HANA. Conducting systematic client workshops to drive and derive key design decisions with industry best practice recommendations will be a crucial part of your role. In this position, you will lead the engagement efforts at different stages, from problem definition to diagnosis, solution design, development, and deployment in large S/4 H...

Alkem Laboratories Limited is an Indian multinational pharmaceutical company based in Mumbai, specializing in the manufacturing and distribution of pharmaceutical generics, formulations, and nutraceuticals across India and over 50 countries globally. Renowned for its top-tier pharmaceutical brands like Clavam, Pan, Pan-D, and Taxim-O, Alkem has consistently secured a position among India's top five pharmaceutical companies. As the IT Business Partner for SCM & Logistics at Alkem, your primary role is to serve as a strategic technology advisor, ensuring that IT solutions are aligned with the company's business objectives for the Supply Chain and Logistics functions. Your responsibilities incl...

Follow applicable departmental Standard Operating Procedures and Work Instructions. Complete required training according to required timelines. Audits System Life Cycle (SLC) activities and documentation. Plan, conduct, and lead global internal facility, system, and process audits. Plan, conduct, and lead external audits of vendors and suppliers. Participates in client and regulatory visits as the subject matter expert in the field of computerized systems and technology compliance. Author and review controlled documents including but not limited to SOPs and policies. Advises internal business, IT, and QA partners on systems and technology compliance. Leads and actively contributes to process...

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...

This role is responsible for managing the external vendor and partner engagements, as well as product and program management and communication efforts for the Technology & Systems team of the Patient Safety and Pharmacovigilance (PS&PV) function This role ensures the successful execution of programs and operations of technology products in line with strategic and operational goals and maintains effective collaboration with external partners as well as with internal stakeholders Major accountabilities: Develop and maintain strong relationships with key strategic partners and vendors for Technology delivery for PS&PV Advise function leadership on best practices for supplier engagement and stra...

Job Summary: We are seeking a meticulous and detail-oriented Quality Checker to join our packaging artwork team. The role requires thorough experience in reviewing packaging artworks for compliance, consistency, and accuracy. The ideal candidate should be familiar with Adobe Creative Suite tools and artwork validation workflows in regulated industries like pharmaceutical or CPG/FMCG domains. Role & responsibilities Verify packaging artwork files against technical briefs, regulatory standards, and brand guidelines. Check alignment, font consistency, spelling, and layout accuracy in Illustrator and InDesign files. Compare artwork revisions using visual comparison tools or side-by-side manual m...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Life Sciences Good to have skills : Salesforce DevelopmentMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time educationDeep expertise in Life Sciences (LS), Veeva CRM, LWC ,Agentforce, and strong Salesforce technical capabilities:Job Summary :We are seeking a Senior Salesforce Technical lead to join our Life Sciences Cloud team. The ideal candidate will have strong hands-on expertise in Salesforce platform development, solid understanding of life sciences commercial processes...

The Director of Product Engineering will play a key role in leading the strategy and development of our Patient Safety software in the life science sector. Your responsibility will be to ensure that our products not only meet the evolving needs of our clients but also excel in functionality, market relevance, and user satisfaction. Success in this role is defined by delivering products that are industry-leading, enhancing user engagement, and achieving strategic business objectives. You will lead the product life cycle from conception to launch, aligning product vision with customer needs and business goals. Conducting market research and analysis to identify trends, opportunities, and compe...

Employment Type : On Contract _ till December 2026 Role & responsibilities: Lead Global GxP relevant IT Projects. Perform Global Quality Approval and Release of GxP relevant IT System Validations Manage, create, implement and maintain of harmonized STADA Global GxP Computer Validation System (CSV) Governance. STADA Global Quality Expert and CSV Champion to provide support to local, cluster and global teams in IT Validations in compliance with Health Authority requirements. Lead STADA Global GxP relevant IT Projects Lead Quality and other Business Teams in IT System Projects to ensure compliance with Health Authority requirements, such as, GxP and Data Integrity Prepare in collaboration with ...

As a Solution Architect with expertise in SAP Manufacturing, you will be responsible for designing, building, and optimizing end-to-end SAP Manufacturing Processes for customers" enterprises. Your role will involve leading large-scale transformation projects within the Manufacturing Workstream, leveraging your experience in PP object data migration in S4HANA. You will conduct systematic client workshops to drive key design decisions, providing industry best practice recommendations. Throughout the engagement process, you will lead efforts from problem definition to diagnosis, solution design, development, and deployment in large S4HANA transformation programs. Your responsibilities will incl...

Educational Requirements Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities SAP ISU Architect with Utility Industry experience. The candidate is expected to play the role of an expert level solution architect and leader covering the necessary process and technology options in large SAP CR&B accounts and transformation programs. The candidate should have good experience across electricity, Gas or Water Utilities industries, and should be experienced and adept at S/4 HANA. As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transfor...

Educational Requirements Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs Create detailed design and architecture, and process artifacts, implement the solution and the deployment plan Connect with senior client business and IT stakeholders, demonstrating thought leadership in domain, process, and technology Contribute to Unit and Organizational initiatives and COEsing potential problems (environments include Sandbox, Development, QA and Production). Add...

Job Location: Bangalore Qualification: Diploma or Degree in Engineering Experience: 2-4 years with Pharma Background Work profile: Plant IT operations Pharma and Biotech companies Installation of OS and application-level critical updates, Service packs, and security patches on workstations. Performance monitoring of all Servers, Desktops, and Networking devices. Installation and troubleshooting of operating systems and software, ensuring efficient deployment and resolution of issues. Applying the OS patches and upgraded administrative tools, maintaining the latest system updates and utilities for optimal performance and security. Remote support to end-users for enterprise-level applications,...

Supplier Quality Data Analyst Duration: Sept 1, 2025 Nov 30, 2025 Location: Remote (Bangalore, India-based) Work Hours: 40 hrs/week, 8 AM – 5 PM EST (flexible) Interview Process: 1 Virtual Round Team: Global Supplier Quality – Operations Pay: 12/hr USD – (41,000 to 42,000/week in India) Role Overview The selected candidate will support the Global Supplier Quality Operations Team with a 50/50 focus on data analytics and quality documentation within a GxP / GMP-compliant environment , using Veeva and Excel-based systems. Responsibilities Maintain and update weekly KPI reports , quarterly performance reports , and supplier quality data sets . Handle supplier qualification documents , including ...

Role & responsibilities Scrum master should be able to create the environment for a team to deliver value, be highly independent, confident in their abilities and flexible enough to adapt to an evolving landscape. Responsible for ensuring Scrum is understood and the team adheres to Scrum practice, and guidelines. Works with Multiple Scrum Teams , as well as internal and external stakeholders, to influence and drive decision making and support organizational project or product teams. Facilitates and supports all scrum events: Sprint Planning, Daily Scrum, Sprint Review, and Sprint Retrospective. Removing impediments or guiding the team to remove impediments. Facilitating discussion, decision ...

Role & responsibilities Lead end-to-end project management for IT/technology initiatives in the pharma/life sciences domain, ensuring timely delivery and within budget. Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Commercial teams. Define project scope, objectives, deliverables, milestones, and timelines. Manage vendor coordination, software implementation, system integration, and infrastructure deployments. Ensure alignment of projects with industry regulations such as GxP, CFR Part 11, HIPAA, GDPR, etc. Prepare detailed project plans, status reports, risk mitigation strategies, and issue logs. Act as a single point of contact for stakeholde...

Responsibilities: Manage CSV projects from start to finish. Ensure compliance with GAMP, GDP, CapA, GXP, IT Compliance & LIMS standards. Collaborate with cross-functional teams on system validation. Free meal Cafeteria Food allowance Shift allowance Over time allowance Travel allowance Sales incentives Annual bonus Performance bonus Marriage & childbirth gifts

Develop, implement & maintain a robust Quality Management System (QMS) in compliance with applicable regulations (GLP, GCP, GXP, ICH guidelines) Create, review, and manage SOPs, work instructions, protocols, reports & documentation across departments Required Candidate profile 4+ years of experience in QA/QC within the pharmaceutical, biotech or drug discovery industry. Quality control certifications are preferred In depth understanding of QA/QC procedures & legal standards

You will be responsible for the site Master Data processes to ensure accurate and timely creation and maintenance of master data in the ERP System, aligning with local and global requirements. As the Material Planner, your role involves driving the tactical purchasing process for all materials to ensure materials availability and execution plan feasibility in accordance with Site inventory policy. Your primary responsibilities will include focusing on accurate and timely preparation and maintenance of master data in the SAP ERP system, aligning with Supply chain operational activities in compliance with GxP & Regulatory requirements, internal regulations, Good Practices, and business objecti...