Review the Quality Regulatory Intelligence inputs and ensure its implementation across the network through review of gap assessments and compliance proposals; and verifying compliance actions for their implementation and effectiveness.
Review of regulatory commitments and its compliance
Perform gap assessment against regulatory audit observations, evaluate and co-ordinate with manufacturing sites for implementation of CAPAs.
Impart training on SOPs to site personnel as and when required.
Support for any organizational corporate initiative assigned
Coordinate with sites for evaluation of quality system and procedures as per requirement.
Providing inputs on Corporate Quality SOPs to comply with current regulatory guidance and requirements.
Shall review best procedures/practices followed at each site and inform to other manufacturing sites for implementation of harmonization procedures/practices across all locations.
Responsible for conducting corporate internal audits and review of various quality systems at site in adherence to CGMP, GxP, Data integrity and any other applicable regulatory requirements.
10-15 years in Pharmaceutical Quality Management in Remediation, Quality Assurance, QMS, Quality Control, Audit & Compliance
Graduation in PharmacyPost Graduation in Pharmacy or Science
CollaborationCustomer CentricityDeveloping TalentInnovation & CreativityProcess ExcellenceResult OrientationStakeholder ManagementStrategic Agility
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
