The responsibilities of a role focused on the development and quality improvement of generic drug products in a pharmaceutical setting. Key objectives include managing multiple formulation development projects, ensuring regulatory compliance, and enhancing product quality through troubleshooting and technology transfer. The position emphasizes collaboration with cross-functional teams, utilizing a Quality by Design (QbD) approach for new product development, and overseeing regulatory submissions, all aimed at successfully launching high-quality pharmaceutical products.
Main Responsibilities:
Monitoring and supporting the Formulation Development Team for the Development of Generic Drug Products, Coordination, planning and implementation across multiple teams. Trouble shooting of Existing Formulations for quality improvement and technology transfer of products & processes.
Monitoring of Technical Trouble shooting of Existing Formulations for Quality improvement and Planning and monitoring of execution of Technology transfer of products & processes from R&D to the local manufacturing plant/sites.
Planning and Monitoring of Feasibility / Assessment/ Registration / Launch validation batches for Technology Transfer from Formulation development to unit Manufacturing Operations. Ensure Quality Management system related activities pertaining to product incidents, Product Problem resolution/ remediation/ Changed notification.
Responsible for successful submission of dossiers of new products and legacy products. Also manage the regulatory queries associated with product development and submissions
Ensure compliance adherence of Formulation Development team and monitor and maintain accurate and complete laboratory records as required by company policy and Current Good Manufacturing Practices(cGMP) requirements.
Planning, designing and performing pharmaceutical experiments for the new product development by QbD approach
Prepare and maintain R & D relevant SOPs as per cGMP and GDP principles
Detail of the Job Responsibilities/Key result areas:
Managing and Schedule multiple projects, set objectives and prioritize activities to meet the milestones in a fast-paced environment through in-house new product development of different dosage forms
Planning and managing new product development, problem resolution, new packaging materials selection, BE/CDP/IVRT studies and Product Dossier submission and providing regulatory intelligence for obtaining Regulatory agencies approval.
To emphasize and execute new product development by QbD approach.
Assist in preparing product manufacturing batch records and protocols at different product development stages, starting from R&D prototype formulations to process validations by following related SOPs and procedures. Ensuring the detailed record and data archiving of formulation Research and Development team.
Responsible for risk assessment, troubleshooting/remediating and process optimization of the product formulation for quality improvement.
Batch size planning for Feasibility, Assessment and Registration batches to meet the equipment capacities and regulatory requirements with minimum consumption
Ensuring Quality Management System related activities pertaining to products like Incidents, Change Notifications, Out of Specification and Out of Trend, Investigation Report Preparation.
Usage of new technology in product development
Monitoring the activities of support departments and Coordinate with relevant stakeholders and ensure the launch of product on time after approval from the agency.
Supporting the Team in the manufacturing of scale-up batches with necessary documentation and technology transfer of products.
Monitoring regulatory queries response and Regulatory documents for dossier preparation, submission and Regulatory notifications.
Handling day to day running of allotted development projects, ensuring high levels of productivities and progression.
Core Competency:
Managerial skills with strong and fffective personal communication and collaboration skills and networking skills and presentation skills
Solution centric mind to understand issues and solve them within a stipulated time frame.
Generic Drug Product development/Formulation development-Quality by Design, Technology Transfer, process improvement and Problem resolution skills
Successful working in a team environment, as well as independently. The ability to work under pressure and multi-task. Self motivated, hardworking and determined. Enthusiastic and committed to excellence in the work.
The ability to follow instructions and deliver quality results.
Strong sense of accountability & Ownership; Fexibility & Adaptability, High level of integrity and professionalism.
Qualification/Functional knowledge:
Master of Pharmacy
Sound Knowledge in Formulation development-QbD approach, Product Problem resolution, Technology Transfer (product development, process enhancement), Technical operation, Packaging development, Regulatory Affairs, Regulatory compliance and dossier submission Process improvement, Process optimization, scale-up, process validation and troubleshooting relating to the formulation and process.
Minimum 15 years of extensive experienced of working in pharmaceutical fields-Product development, Formulation Research and development, Technology Transfer from Research and Development to Unit Operations and Product Life cycle management, BE/ CDP/IVRT, Packaging development, Regulatory Affairs and regulatory submission.
In depth Knowledge in quality Risk management, Risk assessment approach, International regulatory compliance (USFDA, WHO, EU, ICH, GCC, MENA, JFDA ANVISA, TGA, Health Canada)
Sound Knowledge in Audit compliance (Internal, External, suppliers/Vendors)
