ASSISTANT MANAGER
Biocon
- India
- Permanent
- Full-time
- Responsible for Manufacturing& packing of injectables in Generic formulation facility BBSL.
- To handle Installation, qualifications, and media fills of the injectable equipment's and facility
- To handle Isolator filling lines, packing machine, pen devices equipment's , CIP SIP system, single use system
- To handle Aseptic processing activities and to design the process meeting the product and regulatory requirement , ensure its compliance.
- To handle Exhibit batches, New Development batches and to plan the activities and manpower
- To prepare, reviewing and implementation of standard procedures for different activities.
- International and other regulatory audit experience in injectable required and to prepare the facility
- To impart training to the team members as per the requirement.
- To implement GMP and GDP norms in daily production activities.
- To prepare, review and execution of qualification protocols and Validation activities.
- To handle the VLMS, DMS,SAP and Track wise elements online.
- Preparation of SOPs, Protocols, batch records and QMS documents like change controls, CAPA, deviations and other quality documents, whenever required as per GDP.
- To maintain the inventory of change parts and consumables
- To qualify the equipment's meeting the regulatory requirement
- To monitor the daily production plan and to prepare BOM/Recipe in SAP and assure stage wise batch confirmation in SAP.
- To co-ordinate with internal stake holders like Warehouse, QA, QC, Maintenance to meet daily and monthly production plans.
- To coordinate with maintenance persons for on time maintenance scheduling for equipment.
- To facilitate R&D for product scale up, product validation as per production plan.
- To coordinate for execution of Media fill and exhibit batches.
- To coordinate and support R&D for smooth transfer of technology of planned products.
- To ensure the compliances of the documents and practices and upkeep of the areas.
- Collaborate with manager to identify opportunities for process improvement and contribute to the implementation of efficiency initiatives.
Required Experience: 5 - 10 years