7 Validation Documentation Jobs

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), and Performance Qualification (PQ) test scripts. Additionally, you will prepare detailed Test Execution, Test Reports, and Validation Reports. In terms of system validation and deployment, you will be responsible for supervising both global and local manufacturing IT system deployments to ensure adherence to regulatory standards such as FDA, EMA, and GxP. You will also provide support for system validation related to new implementations, upgrades, and modifications. As part of compliance management, you will be required to ensure that all IT systems meet relevant regulations, standards, and internal policies. You will play a key role in driving effective change management and handling deviation management processes. Collaboration with cross-functional teams will be essential for executing thorough system testing and validation activities. You will be expected to maintain traceability between requirements, test cases, and executed results. Experience with Agile methodologies or a willingness to work in Agile environments is preferred. Engagement with stakeholders, including project teams, Quality Assurance, IT, and Manufacturing teams, will be crucial for ensuring seamless project execution. Effective communication to provide progress updates, address issues, and report compliance metrics will be an integral part of your responsibilities. To qualify for this role, you should have a minimum of 5 years of experience in CSV within the pharmaceutical industry. Proficiency in creating validation deliverables, experience with global and local manufacturing system deployments, and familiarity with Agile methodologies are essential requirements for this position.,

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 guidelines and standards are met, providing training to customers on operating the equipment, providing supervisory and technical support to colleagues, understanding new equipment/technology, and sales activities like generating AMC revenue, service revenue, spares revenue, sales inquiries, and attending courtesy calls. After-sales service involves repairing faulty equipment on-site and in the office, free service calls, and coordination with OPD and Sales. The requirements for the role include good analytical and technical skills, result-oriented and achievement-driven mindset, knowledge of validation documentation, good communication skills, ability to work independently and under pressure, and willingness to travel. The interested candidates can submit their CV and application letter to jobs@saksham.co.in.,

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 Balances, Equipment Sizing, and Critical Design Parameters. Additionally, you will prepare and evaluate User Requirement Specifications (URS) and oversee various tests and validation protocols such as FAT, SAT, DQ, IQ, OQ, and PQ to ensure compliance with regulatory standards like GMP, WHO, USFDA, and EU. Collaboration with cross-functional teams such as R&D, Quality Assurance, HVAC, Utility, Electrical, Instrumentation, and Automation will be a crucial part of your role. Your technical expertise and leadership will be essential during project execution, commissioning, and regulatory audits. Client meetings, technical presentations, and troubleshooting activities will also be a part of your regular responsibilities, along with international travel for projects, site visits, audits, and technical review meetings. To qualify for this position, you should hold a Bachelor's or Master's degree in Chemical Engineering or Pharmaceutical Engineering with 8 to 12 years of experience in process design and execution of pharmaceutical plant projects. A deep understanding of regulatory requirements including GMP, WHO, USFDA, and EU is essential. Demonstrated leadership skills in managing diverse teams and external consultants/vendors, excellent communication, documentation, and presentation abilities, as well as the capability to handle multiple projects under strict timelines are required. A valid passport is mandatory for this role, and prior international exposure is highly desirable. In return, we offer you a challenging leadership role in global pharmaceutical projects, opportunities for international exposure and career advancement, a collaborative work environment that emphasizes innovation and compliance, as well as competitive compensation and benefits in line with industry standards. To apply for this position, please send your updated resume to suchita@spectronova.com with the subject line: Application for Process Head Pharma Projects.,

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 testing using test management tools. Furthermore, you will need to prepare validation documentation, which includes test scripts, validation protocols, and summary reports. The role requires the ability to work both independently and as part of a team, with a strong emphasis on quality and attention to detail.,

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