5 Gxp Compliance Jobs

In this vital role, you will support the implementation and operational management of real-world evidence platforms at Amgen, ensuring integrity and compliance of critical systems and data. The role requires close collaboration with developers, business analysts, and product managers to ensure detailed and quality technical delivery in an Agile environment. You will maintain efficient development workflows, ensure robust testing practices, and uphold compliance with GxP and regulatory standards . Key Responsibilities Develop detailed test plans and strategies based on project requirements Perform manual and automated testing , including functional, regression, and performance testing Document and report defects/issues and collaborate with development teams for resolution Maintain documentation of test/validation plans, test cases, and results Validate test scenarios against acceptance criteria and customer expectations Ensure user stories and requirements are well documented in Jira Provide technical validation support to meet quality, cost, and troubleshooting objectives Prepare, execute, document, and report validation protocols compliant with GxP and regulatory requirements Ensure validation procedures align with corporate and government regulations Perform IQ, OQ, and PQ validations for processes, equipment, and systems, including supplier coordination when needed What We Expect of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications Master's degree with 46 years of experience in Life Sciences, Biotechnology, Pharmacology, or Information Systems OR Bachelor's degree with 68 years of experience in the above fields OR Diploma with 1012 years of experience in the above fields Functional Skills Must-Have: Strong problem-solving skills for complex technology challenges in drug discovery Experience with Agile methodologies (Scrum) Strong communication skills with ability to present to senior leadership Experience with validation , compliance , and data integrity standards Good-to-Have: Familiarity with cloud platforms (AWS, Databricks) and GCP regulations Experience with validation solutions in life sciences Ability to communicate complex subjects in business-friendly terms Experience with Jira Align Professional Certifications (Preferred) SAFe for Teams certification Soft Skills Works well under minimal supervision Excellent analytical and troubleshooting abilities Strong verbal and written communication Effective collaboration in global, virtual teams Initiative and self-motivation Ability to manage multiple priorities successfully Strong team orientation and public speaking skills Shift Information This position requires late, second, or third shift schedules Must be willing and able to work evening or night shifts as per business requirements

To develop, ensure, implement and maintain a GxP compliant Laboratory systems. To ensure training and effective implementation of current Good Laboratory Practices. To establish and ensure analysis, approval / rejection of starting materials, packaging materials, intermediate, bulk & finished products as per validated Pharmacopoeia / In house method for Oral Dosages and LVP facility. To ensure that the appropriate validations, including analytical procedures, and calibrations of equipment are done. To Ensure the Maintenance of the Department, Premises and Equipment. To ensure all necessary testing and stability studies are carried out for Oral Dosages and LVP facility as per the approved specifications and applicable guidelines. To ensure that the specifications and the testing methods are in line with the latest guidelines and applicable pharmacopoeias To approve specifications, sampling instructions, test methods & other Quality control procedures for oral and liquid injectable facility. To approve and monitor all contract analysis. To Ensure the required initial and continuing training of Quality Control personnel is carried out and adapted as per requirement. To assist in the investigations related to the laboratory, product failure, incidents and Risk assessments. Review and disposition of the non-conforming materials in co-ordination with Quality Assurance. To ensure the compliance of the Quality Management System and CAPA effectiveness related to the Laboratory. To apply total quality management tools and approaches to analytical and reporting processes. Create and direct environmental monitoring programs in line with the regulatory requirements. To continuously review quality control processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements and making recommendation for improvement as appropriate. To monitor and report quality control progress, notify any discrepancies or potential concerns to the site Quality Head. Support the development of quality goals and targets as part of the organization s strategic plan. Maintain active role on internal continuous improvement initiatives. To Design, develop and implement quality control training programs. To ensure the self-training in the ISO train within the stipulated time frame. Business Administrator for Darius System, to ensure the review and approval of documents in Darius. To be responsible for Laboratory Quality management system and internal Audit as per NABL ISO/IEC 17025. In absence of the position holder, the Manager/ Group manager working in the respective section or shall be responsible for day to day working. Minimum Education M.Sc / B.Pharm / M.Pharm / Ph.D in pharmacy having relevant experience of around 15+ years in quality control functions in a formulation plant. Should have faced and managed regulatory audits such as USFDA / EU GMP independently

Focus Areas Computer System Validation (CSV) with a strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Strong understanding of periodic reviews and audit trail assessments for computer system validations, ensuring compliance, system integrity, and risk identification. Manages supplier relationships for software applications, including vendor selection and qualification, contract management, and ensuring timely and quality software delivery. Oversees the Quality Management System (QMS) for computerized systems, ensuring compliance, documentation, and continuous process improvement. Responsibilities Strong project management skills with experience supervising quality professionals working with cross functional and global stakeholders across multiple time zones. Develop, Mentor, and oversee staff and day-to-day GxP activities. Assess and guide the team in performing Periodic Review of Systems and Audit Trail Reviews. Manage change controls, validation and review and approval of validation deliverables per procedure (e.g. Validation Plan, Test Strategy, Validation Summary Report, etc.). Supplier Management activities for Computerized Systems and other validation disciplines/processes (e.g. Equipment, Analytical, etc.) Support, review and approval of failure investigations & CAPA as a Quality Contact pertaining to Computer Systems. Business Owner activities for systems owned by Quality Assurance (e.g. SAP QM, Veeva, Kneat). Participation and support of regulatory inspections as needed. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems. The following are some examples of tasks for the position Strong understanding of Risks Assessment and how to apply risk-based decision making to all processes related to IT systems. Determine and establish requirements for system/equipment or processes. Act as a reviewer and approver for SOPs, validation deliverables and /or QMS related records (Deviation/CAPA). Review and Approve System Life Cycle Documents (i.e. Validation deliverables). Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. Leverages qualitative insights and quantitative research, analyzes trending data, and utilizes forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance. Anticipates and prevents potential problems. Independently develop solutions that are thorough, practical and consistent with functional objectives. Provides management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards. Bring topics and critical decisions to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes compliance. Basic Qualification Masters degree with a minimum of 10 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration) OR Bachelors degree with a minimum of 14 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration). Strong understanding and ability to apply GxP requirements in Information systems. Possesses a strong understanding of industry standards and business principles. Contributes to work group/team by ensuring quality of tasks/ services provided by self and others. Candidate may need to work hours outside the standard workday or work in different time zones to support business needs. Preferred skills Demonstrated experience (3-5 years) training others in activities outline above. Establish/Improve and actively participate in training curriculum and delivery of this material.

KEY RESPONSIBILITIES The incumbent will work closely with the Corporate Quality Assurance teams under the supervision of the Digital Business Partner, leading articulation of key technology and digital requirements and ensuring successful rollouts. More specifically s/he will lead the following responsibilities: Business Analysis: Point of contact and between business, IT, end user and other cross functional teams during the project or maintenance phase. Collect data, analyse & define the business and user requirements. Analyse business problems and facilitate in IT solution evaluation. Work closely with managers and end users to have buy-in for the proposed solution. Creating a detailed business analysis, outlining problems, opportunities, and solutions for the business users and stakeholders. Categorize the functional and non-functional requirements of the business. Conduct post project implementation acceptance and requirements reviews. Perform additional tasks as assigned by the reporting manager, time-to-time basis in DevOps mode. Prepare validation documentation related to release of GxP system. Should have sound knowledge on preparing validation artifacts for GxP IT systems. Should have knowledge of GxP system testing and validation. Sound communication skill with good amount of convincing power (intermediate level). An ideal candidate should be well planned and structured in his/her all deliverables. Must have experience in Pharma IT with hands-on expertise for handling GxP systems. IT Support and Maintenance: Provide IT administrative support for Enterprise systems but not limited to the following. User Management (Creation, Modification, Password reset etc.). User Access Rights Management. Active user list preparation. Support to Biocon users on the enterprise application on service requests, incidents and bug fixes. Periodic review of event logs (as where applicable). Provide support to vendor for fixing IT related issues during breakdowns. Responsible for adoption, creation and Maintenance of Quality Management Procedures as per IT Operation requirements. 1st level Point of Contact for all IT related queries from Biocon users for enterprise systems Co-ordination with Enterprise functional Team for finding the RCA from IT Perspective in their Incidents and CAPAs. Responsible for implement Change controls and log Incidents and deviation related to IT Functions. Responsible for adherence of SLA's defined for various IT administrative support activities. PROFESSIONAL EXPERIENCE / QUALIFICATIONS Bachelor's in Engineering or Master's degree in a related discipline, including a minimum of 4-6 years of experience gained in technology implementation in the Pharma space Specific experience as a Business Analyst in a GxP application for a pharma company Excellent oral/ written communication skills Self-starter, with the ability to work and execute independently with minimal oversight.

At SAP, we enable you to bring out your best. Our company culture is focused on collaboration and a shared passion to help the world run better. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly collaborative, caring team environment with a strong focus on learning and development, recognition for your individual contributions, and a variety of benefit options for you to choose from. What youll do: As a GxP Expert at SAP IPE, you will be responsible for creating and maintaining GxP compliance strategies for SAP's Life Sciences solutions. You'll play a pivotal role in shaping the product strategy, driving innovation, and ensuring the product delivers exceptional value to our customers keeping GxP in perspective. This position requires deep industry knowledge in the Life Science Industry, and the ability to collaborate across various teams to bring a successful and compliant product to market Develop and maintain GxP compliance strategies for SAP's Life Sciences solutions, also focusing on S/4 HANA public cloud. Conduct risk assessments and gap analyses of current systems against GxP requirements. Design and implement GxP-compliant processes and controls within our software solutions. Collaborate with development teams to ensure GxP considerations are integrated into product design and development lifecycle. Provide expert guidance on regulatory requirements (e.g., FDA 21 CFR Part 11, EU GMP Annex 11) to internal teams and customers. Assist in customer audits and regulatory inspections related to GxP compliance. Stay current with evolving GxP regulations and industry best practices, ensuring SAP remains at the forefront of compliance. Be accountable for the success of the industry product(s), ensuring SAPs products deliver on customer expectations. What you bring: Atleast 5+ years of GxP Experience 10+ years of overall experience in Life Sciences Industry in Security or GxP related roles. Proven track record of successfully driving the compliances of products Strong communication skills to engage effectively with customers and internal stakeholders, building trustful and lasting relationships Comprehensive understanding of GxP-regulated industries, with a strong focus on Life Sciences, ideally Clinical Trials Management Strong analytical skills with the ability to translate data into actionable insights Experience with agile methodologies and product development best practices Ability to advocate industry thought leadership both internally and externally. Bachelor's degree in Computer Science, Engineering, Business, or related field Demonstrated ability to balance customer needs, technical constraints, and business objective