Senior Manager / DGM - Corporate Quality Assurance
JUBILANT LIFE SCIENCES
JUBILANT LIFE SCIENCES
Experience: 15 - 20 Years
Location: Greater Noida
- Development of DQA systems in the entire R&D to ensure QbD compliance.
- Development of desired Quality Systems across the LSI manufacturing sites as per ICH requirements.
- Implementation of Company Quality policy, Corporate Quality Audit Program & Regulatory Compliance at all sites.
- Harmonization of systems and procedures across all sites of LSI and designing systems for better documents control.
- To Facilitate Regulatory Approvals at manufacturing sites.
- Providing training on cGMP Compliances at all the manufacturing facilities.
- Keeping track by close monitoring of key quality attributes e.g. change controls, Deviations, CAPA, Investigations, Complaints, OOSs etc.
- Qualification of Toll Manufacturing sites
- Vendor Audits for Raw & Packaging Materials
- Preparation & implementation of CQA guidelines and Quality Plan
- Implementation of ISO 9001 Quality Management Systems.
- Guidance & Support on GMP & GLP issues to LSI Manufacturing sites
- Exposure in International Audits like USFDA etc..
- LSI Manufacturing Sites: GMP audits, Gap analysis, suggestion on Corrective and preventive actions, ensuring compliance.
- Audit, review of compliance and approval of Toll manufacturing sites of LSI.
- Providing cGMP and GLP training to LSI Manufacturing sites & R&D
- Participation in the Development and Implementation of Regulatory Strategy
- Formulates an organized contingency plan based on the project's critical factors and a risk-mitigation plan.
- Specifies the different project phases and the corresponding deadlines.
- Provides suitable support to stakeholders in implementing the strategy
- Preparation, Submission, and Follow-up of a Regulatory registration dossiers and other registration documents and achieve product registrations.
- EU REACH registration of products, Maintenance of dossiers.
- Handling registration of products other emerging REACH like regulations - Turkey, Taiwan. Keep track of emerging REACH like regulations across the globe and handle necessary registration actions
- Review of current regulatory guidance documents, making CQA Guidelines on key topics in line with the cGMP requirements.
- Implementation of CQA Guidelines in LSI manufacturing sites in India.
- Providing Guidance & support to down the line CQA Team
- Providing support to LSI manufacturing sites on various GMP issues.
- Audit and approval of Raw and Packaging material vendors.
- ISO 9001 Quality Management System
- ISO internal Audits of HO, R&D & Branches
- Preparation & Implementation of ISO mandatory System requirements
- Support to HO, R&D and Branches during ISO External Audits.
Desired Candidate Profile
PG - MS/M.Sc(Science) - Chemistry, Any Specialization
Jubilant Life Sciences Ltd
Jubilant Life Sciences Limited,(erstwhile Jubilant Organosys) is an integrated Pharmaceutical & Life Sciences company. As India's largest Custom Research and Manufacturing Services (CRAMS) player and a leading Drug Discovery and Development Solutions provider out of India, it is constantly engaged in delivering value to its global customers through innovative technologies, products and services. The Company’s strategic focus is to innovate, collaborate and accelerate the process of delivering products to the market for its customers. Today, it is well recognised as a ‘Partner of Choice’ by leading global pharma and Life Sciences companies. The Company through its presence in India, USA, Canada, Europe and China constantly serves its customers in over 60 countries across the globe.