12 Validation Documentation Jobs

Role Overview: Join Amgen's mission of serving patients by becoming a key member of the team that helps research, manufacture, and deliver innovative medicines to improve patients" lives. As part of Amgen, you will have the opportunity to make a lasting impact on patients while transforming your career. The culture at Amgen is collaborative, innovative, and science-based, providing you with a challenging yet rewarding environment to thrive in. Key Responsibilities: - Lead the execution of complex or novel assignments requiring strategic planning and development of new validation techniques - Supervise validation activities, conduct risk assessments, and establish policies for computer system...

As a MES Consultant or Recipe Author, you should have experience in Rockwell PharmaSuite MES and a solid understanding of pharmaceutical manufacturing processes, particularly in solid oral dose and packaging. Your skills should encompass EBR design and configuration, validation documentation, and ensuring GMP compliance. Proficiency in tools such as Microsoft Visio, Rockwell PharmaSuite, and any legacy EBR tools like P2C2 and PMX is essential for this role. Having experience in working with Italian clients would be a bonus, especially if you possess Italian language proficiency. The preferred start date for this position is July 1, 2025. The job locations available for this role are in India...

Role & responsibilities Complete knowledge of Validation ( AHU / Autoclave / Dry Heat Sterilizer etc ) and Calibration -Capable of Compiling the Validation and calibration Activities -Good Computer Skill Preferred candidate profile CLEAN SHAVEN MALE CANDIDATE WITH MINIMUM 2-3 YEARS EXPERIENCE IN STERILE INJECTION SECTION

The job is located in Mumbai and Pune. You should have a B.Sc./Diploma/B.E in ECE, EEE, EIE qualification. This position is for male candidates. You should have a minimum of 2 to 4 years of servicing experience on Pharmaceutical or Biotechnology laboratory equipment. Your responsibilities will include: - Customer support and installation - Managing installation and commissioning - Understanding customer product and site requirements - Resolving issues at customer sites - Ensuring guidelines and standards are met - Providing training to customers - Providing supervisory and technical support to colleagues - Understanding new equipment and technology - Generating AMC revenue, service revenue, ...

As a Validation Specialist, you will be responsible for leading and conducting Computer Systems Validation (CSV) activities for IT systems utilized in pharmaceutical manufacturing settings. Your role will involve authoring comprehensive validation documentation, overseeing system validation and deployment, ensuring compliance with regulatory guidelines, managing compliance, conducting testing and quality assurance activities, contributing to Agile practices, and engaging with various stakeholders. You will be tasked with creating Validation Plans, Test Plans, and Requirements Specifications, as well as developing and executing Installation Qualification (IQ), Operational Qualification (OQ), ...

Seeking a driven Pharma IT Sales Executive to lead growth in pharma/life sciences. Must excel in consultative sales, positioning validation, compliance, audits. Engage CXOs, QA, IT heads with trusted, value-driven solutions. Regulatory standards

The job is located in Mumbai and Pune and requires a candidate with a qualification of B.Sc./Diploma holder /B.E in ECE, EEE, EIE. The position is open for male candidates with a minimum of 2 to 4 years of servicing experience on Pharmaceutical or Biotechnology laboratory equipment. The products involved include Process Equipment/Autoclave, Washers, DHS, Isolator, Glove box, Pure steam generator, and multiple Distiller, Fermenter. The customers serviced are Pharmaceutical Companies. Job responsibilities include customer support such as installation, managing installation and commissioning, understanding customer product and site requirements, resolving issues at customer site, ensuring guide...

As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will be responsible for leading the process engineering aspects of pharmaceutical plant projects. Your role will involve overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. Your key responsibilities will include leading the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. You will be required to develop and review essential documents including P&ID, Process Flow Diagrams, Mass Ba...

You should have knowledge of regulatory standards such as GxP and FDA 21 CFR Part 11. It is essential to collaborate effectively with developers and stakeholders to proactively understand and analyze the application requirements. Your responsibility will include creating comprehensive test cases and scenarios based on risk-based approaches, with a specific focus on critical functionalities and compliance aspects of the application. You must ensure that the test cases are traceable to the system requirements and risk assessments. Additionally, you will be required to execute IQ/OQ/PQ to validate the application. It will also be your duty to log, track, and manage defects identified during tes...

Role & responsibilities Validation Engineer • Expertise in preparing end-to-end validation documentation including protocols and reports. Collaborates closely with the testing team to ensure execution aligns with requirements. • Should utilize a risk-based approach for validation/testing. Veeva tool Preferred candidate profile

Develop and execute manual test scripts, create validation artifacts (IQ/OQ/PQ, UAT), perform dry runs and defect retests, trace requirements, collaborate with cross-functional teams, and support agile-based QA across Veeva Vault applications. Required Candidate profile Manual QA professional with 2+ years in Veeva Vault testing, experience in validation documentation, agile SDLC, pharma domain exposure. Preferably familiar with SFDC/Veeva CRM and basic automation

Job Summary: We are seeking a highly skilled and detail-oriented Computer System Validation (CSV) Consultant with proven experience in validating SAP systems (SAP ECC, SAP S/4HANA, SAP GxP modules, etc.) within regulated environments such as the pharmaceutical, biotechnology, or life sciences industries . The ideal candidate will be responsible for ensuring SAP systems are compliant with GxP regulations, 21 CFR Part 11, Annex 11 , and other applicable standards by leading and executing validation activities throughout the system lifecycle. Key Responsibilities: Lead and perform CSV activities for SAP systems, including validation planning, risk assessments, and test script development (IQ/OQ...