421 Gxp Jobs - Page 10

1. Understanding of various SDLC methodologies (Agile, Waterfall, V) 2. Experience in Programming or scripting languages (Java/JS etc.,). 3. Experience in designing automation frameworks (POM, Cucumber BDD, etc.,). 4. Generate Automation Test Strategy for applications deployed on Cloud. (Public and Private cloud) 5. Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. 6. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest API, etc. 7. Good experience with VAPT. 8. Knowledge of Performance testing using Jmeter or any open-source tools. 9. Perform Risk Analysis of Project & automation...

JD: GxP Manual Functional Tester: • Minimum 6+ years of experience in manual testing in GxP-compliant environments • Good understanding of STLC, Functional testing, FIT, UAT, Defect Management • Hands on experience in FIT Test case design and executions • Hands on experience in UAT test design • Working experience with Agile Incremental testing • Experience with test management tools (Jira) • Understanding of SDLC and Agile methodologies • Good communication and documentation skills • Collaborate with business, development, and regulatory teams • Track and report defects using Jira or similar tools

You will be responsible for preparing and adhering to the annual planner for Quality audits for Loan Licence Units (LLU), Third-Party Manufacturing Sites, public testing laboratories, and Shalina Operating Units (OUs) to ensure GMP and GLP compliance. This includes conducting periodic, due diligence, and for-cause quality audits to monitor overall performance. You will review audit compliance reports for any external, regulatory, or customer audits, ensuring the closure of individual observations by reviewing relevant supporting data. Additionally, you will conduct self-inspections of individual departments, compile reports, track and review compliance for timely closure, and maintain audit ...

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback...

Responsibilities Lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment, contribute to unit level & organizational initiatives Worked as Subject Matter Expert in SD area Experience as a Solution Architect in Logistics, Functional Lead in SD with experience in implementation, Logistics solution (Conducting workshops, Design, Testing, Data Migration and hyper care cutover activities) Strong knowledge of Sales Process, Intercompany transaction, 3PL Logistics, Toll Manufacturing transactions / business processes and best practices Exposure to other Logistics area like Procurement, Warehouse Management, Transport Managemen...

Responsibilities Lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment, contribute to unit level & organizational initiatives Worked as Subject Matter Expert in SD area Experience as a Solution Architect in Logistics, Functional Lead in SD with experience in implementation, Logistics solution (Conducting workshops, Design, Testing, Data Migration and hyper care cutover activities) Strong knowledge of Sales Process, Intercompany transaction, 3PL Logistics, Toll Manufacturing transactions / business processes and best practices Exposure to other Logistics area like Procurement, Warehouse Management, Transport Managemen...

Responsibilities Lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment, contribute to unit level & organizational initiatives Worked as Subject Matter Expert in SD area Experience as a Solution Architect in Logistics, Functional Lead in SD with experience in implementation, Logistics solution (Conducting workshops, Design, Testing, Data Migration and hyper care cutover activities) Strong knowledge of Sales Process, Intercompany transaction, 3PL Logistics, Toll Manufacturing transactions / business processes and best practices Exposure to other Logistics area like Procurement, Warehouse Management, Transport Managemen...

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 applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system fu...

Educational Requirements Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities Design, Build & Optimize End to End SAP Manufacturing Processes for customers enterprise Leading large scale transformation projects Manufacturing Workstream leveraging experience including PP object data migration experience in S/4HANA Conduct systematic client workshops to drive & derive Key Design Decisions with Industry best practice recommendations 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 a...

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). Additional Responsibilities: SAP BASIS with experience in any of the following industry (Pharma, Professi...

About Shalina Healthcare: Shalina Healthcare is among the largest privately owned pharmaceutical businesses in Africa with its Global Headquarters based in Dubai, UAE. The company has recently diversified into new lines of businesses such as Digital Healthcare, Diagnostics, and Consumer Healthcare. Shalina Healthcare has a remarkable track record and its brands are highly trusted across Africa. With a vision to become the health champion of Sub-Saharan Africa by 2030, the company is seeking individuals who can contribute to its growth and make a positive impact on the communities it serves. If you share our Core Values and are passionate about our Mission, we welcome you to join us on this j...

You will be working as a Lead-SAP Production Planning at Percipere, an established Premier Process Integrator based in the UK with a fast-growing presence in Europe, America, Middle East, and India. The role is based in Mumbai and is crucial in achieving the ambitious growth targets set by the organization. Your responsibilities will include designing, building, and optimizing end-to-end SAP Manufacturing Processes for customers" enterprise. You will lead large-scale transformation projects in the Manufacturing Workstream, leveraging your experience in PP object data migration in S/4 HANA. Conducting client workshops systematically to drive key design decisions with best practice recommendat...

EY- GDS Consulting Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with ...

OVERALL OBJECTIVES: As a senior member of the team, you will join a challenging and unique large-scale Transformation Program with high impact and visibility. Primary focus is the assessment, planning and implementation of new or improved IT Services as part of the project engineering team. Senior Reliability Engineer (SRE) is primarily responsible for the engineering, configuration, installation, and maintenance of; Windows physical and virtual servers, Active Directory, Azure cloud and on-prem environments based on Hyper-V/VMWare, storage, backups, and disaster recovery planning. We rely on our engineers to empower our users with high availability, excellent performance levels and key serv...

Job Description Summary: Leads and supports establishing and maintaining the GxP management system of the ARD Line Units at site level, serves as a contact point between local QA and the local ARD Line Units for general inquiries, represents the ARD in GxP-related committees and networks. Lead and manage all compliance/project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals. Responsibilities include, but are not limited to: Oversee and lead all activities of assigned teams /projects to meet customer needs. Work according to appropriate standards for quality, ethics, health, safety, environment, protection and i...

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,...

Computer System Validation (CSV) Exp. :- 3-9 yrs Location :- Pune Work youll do As a part of our Technology & Transformation team, Youll: Support on IT quality systems framework design and implementation Managing the reviews and assessments for IT quality Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies GxP Business process review Development of integrated GxP and IT compliance Standard operating procedures and guidelines GxP and IT compliance assessment Define the Validation strategy of IT Software and Systems Actively...

Dear Candidate, Greetings of the Days!! Qualification:- BE or B-Tech Computer sciences. Exp:-5 Years to 10 Years. Salary :- Depends on Candidate Skills and Competency Mapping. Location:-Ahmedabad Job Description:- 1.IT Digital Operations:-Managing Automation, Cloud Services, and Overall IT Work Flow. 2..IT-Infrastructure: Overseeing Data Centre, Physical Servers, VM servers, File server, Network devices, Firewall, Antivirus Crowd Strike, Deep Security, AD, Group policy, Data backup Agents Actifio/Netveritas/Veem Agent/ECM Agilent tool, software systems, and security frameworks for reliable IT performance. 3.Leading IT-CSV Role (Computer System Validation): Overseeing validation activities fo...

Roles and Responsibilities Manage IT infrastructure, including servers, storage, network devices, and virtualization platforms (VMware). Ensure compliance with regulatory requirements such as GXP/GMP/21 CFR Part 11 through documentation and implementation of controls. Develop and maintain CSVs (Computer System Validation) protocols for new equipment installations or upgrades. Collaborate with cross-functional teams to identify opportunities for process improvements and implement changes using tools like Anaplan. Provide technical support for IT systems, troubleshooting issues related to hardware failures or software malfunctions.

• 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 Collect samples for analysis from custodian. Processing of sample by using various sample extraction technique (to determine the concentration of analyte). Perform analysis via LCMS. Follow GXP. Sample extraction process using LLE, SPE, PPT. Stability issue handling, derivatization, etc. approach. Receive controlled forms for various activities. Document all linked activities and forms as per SOP. To check documents done by Jr. Analyst/ Fresher. Method development skills Trouble shooting of method Excel and MS Word.

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...

Handle market complaints received from across the globe. You will be responsible for reviewing the investigation reports received from Novartis sites and Contract Manufacturing Organizations. Collaboration with external Supply organization, Novartis sites, and Country pharma organizations for continuous improvement is essential for this role. As a Specialist - Product Complaints - QOP based in Hyderabad, your key responsibilities will include performing day-to-day activities of processing market complaints assigned as per the relevant SOPs, business matrix, and SLA timelines. You will assist in data collection and reporting of KPIs, support continuous improvement initiatives, manage ad-hoc p...

You will be responsible for managing core IT infrastructure, which includes servers, storage, virtualization, and telephony systems. Your main tasks will involve performing continuous monitoring and proactive/preventive maintenance to ensure smooth operation. Additionally, you will need to quickly identify and resolve hardware/software issues and performance bottlenecks. As part of your role, you will be required to implement infrastructure projects, upgrades, and new tool rollouts. You will also need to conduct regular system reviews to ensure compliance with GMP/GxP systems, contributing to audit readiness and regulatory alignment. Maintaining technical documentation, SOPs, and project rec...

The job involves following departmental Standard Operating Procedures and Work Instructions, completing required training within specified timelines, and auditing System Life Cycle (SLC) activities and documentation. You will be responsible for planning, conducting, and leading global internal facility, system, and process audits, as well as external audits of vendors and suppliers. Additionally, you will participate in client and regulatory visits as a subject matter expert in computerized systems and technology compliance. You will also be involved in authoring and reviewing controlled documents, advising internal business, IT, and QA partners on systems and technology compliance, and lead...