2 Gamp 5 Jobs

Job Description: Proffered Profile: Bachelors degree (BE/B tech) with 3-5 years of experience in IT QMS Compliance Specialist ensures alignment of all IT systems, processes, and documentation with internal Quality Management Systems (QMS) and applicable regulatory standards such as GxP, ISO 9001, 21 CFR Part 11, and EU Annex 11. This role plays a key part in audit preparedness, deviation management, and maintaining consistent quality across IT operations and projects. Key Responsibilities: Develop, implement, and maintain IT quality policies, SOPs, and work instructions in accordance with QMS. Ensure compliance of IT systems with relevant regulatory requirements (GxP, 21 CFR Part 11, GDPR, etc.). Collaborate with QA, Validation, and Business teams for development, qualification, and maintenance of IT systems as per CSV and QMS guidelines. Manage QMS elements such as deviations, CAPAs, change controls, audit trails, and periodic reviews. Participate in internal/external audits; coordinate documentation, evidence, and responses. Conduct IT quality risk assessments and support necessary remediation. Maintain accurate records of compliance activities, including SOP training and validation documentation. Deliver training programs to IT teams on QMS processes and compliance awareness. Support full lifecycle management of computerized systems (planning, validation, operation, retirement). Assist with vendor qualification and assessments for IT-related services. Required Skills and Qualifications: 3 - 5 years in IT compliance/QA/validation in a regulated industry Working knowledge of ISO 9001, GAMP 5, 21 CFR Part 11, EU Annex 11 Familiar with LIMS, ERP, MES, DMS systems Strong documentation and analytical skills Good understanding of ALCOA+ and data integrity Preferred Certifications: ISO Lead Auditor, Six Sigma, or other Quality Management certifications

Let's do this. Let's change the world. We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance. Validate test scenarios against feature acceptance criteria and customer expectations. Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability. Identify opportunities to enhance testing efficiency and minimize manual efforts. Evaluate and adopt tools and technologies to improve automation capabilities. Keep validation documentation updated and aligned with GxP standards. Ensure strict adherence to change management processes for validated systems. Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms. What we expect of you: We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master's degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor's degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Experienced in GxP validation process Have 4-5 years of experience in the Pharmaceutical Industry Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience in writing requirements for the development of a modern web application Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11 Proficiency in automation tools, data systems, and validation software Preferred Qualifications: Experience in Clinical Trial Registry and Regulatory submission publishing systems and processes Knowledge of the Disclose application from Citeline and docuBridge from Lorenz Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific software systems strategy, governance, and infrastructure Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills