Primary Responsibility:
Strategic:
• To work closely with the project team to build state-of-the-art manufacturing facilities that comply with US/EU and local norms.
• Responsible for all drug product-related manufacturing activities in the washing area, Formulation area, filling area and Component Preparation area in Cartridge, PFS, Vial line and DP Operations of Unit-2-associated equipment.
• Design, build, implement, manage, audit and maintain drug product manufacturing suite and handling commercial manufacturing activities.
• Coordinate with the customer/Client for project execution and participate in customer meetings for project/product execution and follow-ups.
• Preparing, planning and coordinating for regulatory and customer audits. Implementing the post compliance recommendations of the audit observations.
Operational :
• Preparing, reviewing qualification documents like URS, QRM, DQ, CLIA, SLIA, IQ. OQ, PQ, FAT /SAT protocols and verifying the deviation lists.
• Performing the FAT & SAT at vendor sites or our facility.
• Ensuring production planning & execution.
• To ensure timely deliveries to meet the customer requirements.
• Developing layouts of drug product and warehouse layouts as per guidelines along with the project team.
• All routine manufacturing operations of the packaging area, visual inspection activity and relevant CGMP requirements.
• Ensuring implementation of workplace safety-related procedures/primary protective equipment (PPE) for the overall drug product manufacturing area.
• Prepare, review and approval of all SOP`s/Protocols related to Equipments and DP Operations of Unit-2.
• Building & developing a strong drug product team & planning periodic training for operators and juniors related to SOP.
• Ensure all the materials /consumables required for the production batches are procured and inventory is maintained.
• Capex/Opex budget preparation for the DP facility of Unit- 2.
• Review and approval of SOPs, BMR’s and other Validation Protocols.
• Active calculation and Batch reconciliation on various stages.
• Preparation and execution of media fill studies for Liquid Vial/ lyo, Cartridge, PFS facility, DP Operations of Unit-2 & filling line.
• Hands-on experience implementing good manufacturing practices in the DP Operations of Unit 2.
• Extensive knowledge of US GMP compliance regulations and industry practices, as well as EU GMP.
• Represent drug product team in project review meetings.
• Creation of MIS reports and executive summary reports for management review.
• Manage Fill Finish operations as per CGMP requirements
• Identify and implement the procedures in fill finish areas in compliance with current GMP requirements.
• Identify and implement the good safety procedures in the department.
• Identify and implement an effective inventory management system in the department.
• Timely initiation, review and closure of QMS elements.
• Responsible for making decisions in the absence of the Head of Fill Finish Manufacturing.
• Adherence to DP operations performance plan versus actual.
• Adherence to RISE program and initiation.
People:
• Preparation and execution of training modules on SOP in the department.
• Prepare and execution of QMS documents in the department.
• Prepare and execution of training modules on QMS and safety SOP in the department.
• Preparation and execution of training on soft skills to develop the team.
Finance:
• Managing the inventory effectively and accurately.
• Process simplification and optimization to reduce cost and quality compliance.
Experience & Qualification :
M.Sc. with 20+ years of relevant work experience in manufacturing setup, preferably from the injectables (Sterile) or Biologics background.