Manager - Quality ECompliance

Job Description

To have good understanding and knowledge on LIMS application functionalities and its integration with other systems. To provide SME support for the implementation of LIMS (Laboratory Information Management System) across sites and support the key decisions for the changes that required in the workflow of the system from Quality and e-compliance perspective. To support the validation of LIMS application (specifically). Additionally, to support the validation of Enterprise Systems, LMS (Learning Management System), VLMS (Validation Life Cycle Management Systems) and other applications systems to comply with regulatory guidelines. To define validation strategy and provide inputs to validation planning for projects; along with the review of validation/qualification deliverables of the assigned project/system in line with the organizational SOPs adhering to company procedures and regulatory expectations. To ensure infrastructure (Network, Servers, Cloud, Database) are qualified as per required Quality standards and required documents are in place. To support the various phases of Computer System including Planning, Implementation, Maintenance, and Retirement activities by ensuring compliance with internal/external regulatory requirements. To review other QMS documents e.g. Change control/Deviation/ CAPA/Incidents-Discrepancy/User access forms in line with the organizational/site specific procedure. To communicate/discuss the identified gaps during the GxP computerized system assessment to responsible team. Coordinate with the relevant IT team for the compliance/closure of the identified gaps, incidents, deviations. To guide and train IT Business teams at Site for CSV, relevant areas of Compliance and Validation for GxP IT and electronic systems, Data Integrity, and Regulatory Compliance activities. To perform periodic and audit trial review of the GxP application system as per defined frequency along with the relevant stakeholders. To support sites to ensure audit readiness and ability to represent the validation package of enterprise GxP application including LIMS during regulatory audits and can be able to perform DI Audits at site. To coordinate build good working relations with Site/business users, Subject Matter Experts (SMEs) and IT operations team, Manage vendors / partners / support teams. Key Competencies :EY COMPETENCIES: KEY COMPETENCIES: To have in depth understanding of regulatory requirements and guidelines required to comply IT systems in Pharma industry - DI, ALCOA+, Part 11, Annex 11, GAMP 5 etc. Knowledge and Experience of Pharma domain -Quality (QA, QC) Understanding and exposure to Pharma CSV upcoming trends. A team player with good communication skills (verbal written) Knowledge and experience on handling of CSV project related QMS e.g. Change control, deviation, CAPA and incidents. Graduate in Science/Pharmacy/Engineering Post Graduation Science /MBA