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Job Summary
The role is responsible for ensuring that site production systems and equipment, utilities, facilities, laboratory instruments/systems, Data & Tracking systems and User Defined Attributes consistently and reproducibly meet predefined specifications, while maintaining the overall validation status and data integrity requirements in line with GMP and regulatory expectations. The position leads validation strategy and execution, computerized system validation, and the Site Data Integrity Program in close collaboration with cross-functional teams.
Key Responsibilities
Develop, review, and ensure adherence to the Site Validation Master Plan (SVMP) for production processes, systems/equipment, utilities, facilities, laboratory instruments/systems, testing methods, Data & Tracking systems and User Defined Attributes, ensuring timely action closure and status reporting.
Ensure timely development, review, approval, archival, retrieval and retention of validation documents for production, laboratory and in-process systems/equipment, utility systems, areas, applications/software, and related processes in line with approved protocols.
Act as Validation Subject Matter Expert and Change Control Panel member, partnering with Operational Quality to assess Change Controls and Deviations, define validation strategies and collaborate with Technical, Production, Quality, Engineering and Logistics teams to ensure timely execution of validation activities.
Review and approve Process Performance Qualification (PPQ) and Cleaning Validation activities and review Product Control Strategies as a Quality Subject Matter Expert.
Implement and maintain Computerized System Validation (CSV) in alignment with policies and procedures, including development of SOPs, maintenance of validation inventories and management of GMP systems and processes, ensuring timely execution of CSV, area monitoring, thermal mapping, and related validation activities.
Lead the Site Data Integrity Program, acting as the primary point of contact for data integrity, liaising with regional Data Integrity teams and the supply chain steering committee to develop and implement annual site data integrity improvement plans and report metrics to the Leadership Team.
Prepare, update, and monitor adherence to the Site Data Integrity Plan, ensuring alignment with global and local data integrity requirements across the site.
Oversee effective access management processes for GMP systems, including audit trail review determination and implementation, and support site deviations and investigations related to data integrity.
Ensure effective implementation of QMS and EHS within the department by managing and reviewing SOPs, ensuring audit readiness and timely CAPA closure and preparing and approving management monitoring schedules.
Manage the lifecycle of Internal Quality Agreements for the site as part of the Internal Party Management process.
Perform quality approvals of Batch Manufacturing Records in SAP by verifying quality parameters and ensuring maintenance of validated status.
Education, Experience and Skills
Bachelors or master’s degree in science, Engineering, Pharm D or relevant disciple.
Minimum 5–6 years of pharmaceutical operations experience, with the depth required to understand and perform Quality Assurance key processes in line with regulatory and Quality Management System (QMS) requirements.
Strong breadth and depth of knowledge across pharmaceutical disciplines and functions, with demonstrated expertise in validation and quality assurance.
Good written and verbal communication skills.
Sound knowledge of drug laws, local regulations and GMP requirements including GLP, GMP, GDP and Data Integrity.
Strong working knowledge of corporate IT and computerized systems in GMP environments.
Proven facilitation skills and the ability to lead cross-functional discussions and drive decisions.
Demonstrated GSK High-Performance Behavior's including Enable & Drive Change, Building Relationships, Flexible Thinking, Continuous Improvement, Customer Driven and Developing People.
Strong relationship-building skills with the ability to establish effective working relationships within and across teams.
Flexible and innovative thinking with the ability to translate ideas into practical improvements.
Strong influencing, conflict management, problem-solving, and people management skills.
Effective team player with the ability to collaborate across site functions.
High level of initiative and ownership with a proactive “do it first” mindset.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Contact information:
You may apply for this position online by selecting the Apply now button.
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