Manager Quality ECompliance

As a Quality eCompliance professional at Piramal Pharma Solutions, your role will involve ensuring regulatory compliance of Laboratory Information Management System (LIMS) at Global Piramal Pharma sites. Your key responsibilities will include: - Having a good understanding and knowledge of LIMS application functionalities and its integration with other systems. - Providing SME support for the implementation of LIMS across sites and supporting key decisions for system workflow changes from Quality and e-compliance perspective. - Supporting the validation of LIMS application and other enterprise systems to comply with regulatory guidelines. - Defining validation strategy and providing inputs to validation planning for projects, reviewing validation/qualification deliverables, and ensuring infrastructure qualification. - Supporting various phases of Computer System activities by ensuring compliance with regulatory requirements and reviewing QMS documents. - Communicating identified gaps during system assessments, guiding and training IT & Business teams, performing audit trial reviews, and ensuring audit readiness. - Coordinating and building good working relations with Site/business users, SMEs, IT operations team, and managing vendors/partners/support teams. **Essential Qualifications:** - Graduate in Science/Pharmacy/Engineering - Post Graduation in Science/MBA **Relevant Experience:** - 8 to 12 years of experience with LIMS implementation **Key Competencies:** - In-depth understanding of regulatory requirements like DI, ALCOA+, Part 11, Annex 11, GAMP 5, etc. - Knowledge and experience in Pharma domain Quality (QA, QC) - Understanding of Pharma CSV upcoming trends - Strong team player with good communication skills (verbal & written) - Experience in handling CSV project related QMS activities like Change control, deviation, CAPA, and incidents This role will report to the Associate General Manager - Quality eCompliance and will involve collaborating with internal stakeholders such as Business and IT teams, as well as external stakeholders like IT Vendors and Contractors/Consultants. This position is based in Kurla with medium travel requirements. Note: Additional details about the company were not provided in the job description.,