DGM - Drug Product (Filling) - Vaccine Division

Role & responsibilities

• Responsible for Drup Product Manufacturing
• Ensure compliance to Current Good Manufacturing Practices (cGMP)& documentation thereof for various production activities.
• Filling line in built CIP, SIP operations
• Knowledge of Isolator VHP, Blending vessels- CIP, SIP
• Good at QMS
• Regulatory inspection exposure WHO-PQ, USFDA, EU GMP, TGA,ROW
• Experience in O RABS, Isolator filling lines
• Lyophilizers - ALUS, Manual operations
• Blending of viral, bacterial vaccines
• Media fill activities , TRS 1044 updates
• Responsible for preparing production plan in consultation with PPIC department and execution thereof with effective planning and utilization of Men, Materials and Machineries for quality linked productivity.
• To approve the instructions relating to production operations and to ensure their strict implementation.
• To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
• To ensure that the production records are evaluated and signed by an authorized person.
• Review investigation of Quality Management System (QMS) including market complaint, Out of Specification (OOS), change controls of manufacturing, risk assessment, Corrective Action and Preventive Action (CAPA) etc.
• To ensure the qualification and maintenance of department, premises and equipment.
• Ensure compliance to master formula and process provided in the Batch Manufacturing Record (BMR).
• To ensure that the appropriate validations are done.
• Reviewing document like of Standard Operating Procedures (SOPs), Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR)etc. and compliance reports thereof with training of personnel on the same.
• Ensure appropriate inventory of Consumable in the Department for smooth functioning.
• Responsible for Co-ordination with Technical Services, Quality Assurance / Quality Control, Finance, Purchase, Warehouse and Administration Departments for effective management of Production targets.
• Ensure wastage control and optimization of yield at various stages of manufacturing and packaging operations.
• Ensure compliance to various In-process control guidelines provided in the batch documents.
• Ensure periodic preventive maintenance of plant and machineries as per schedule worked out by Engineering for optimum performance.
• Ensure that personnel follow basic safety guidelines during operations.
• Responsible for the preparation of training calendar for employees and to ensure that the required initial and continuing training of department personnel is carried out and adapted according to need on cGMP and various operational activities.
• Responsible for preparation of accurate and timely reports of various production activities showing performance and shortcomings against agreed/planned parameters (monthly presentation, work in progress (WIP) statement yield report, monthly planning, expense budget stationary, housekeeping material, production item &capital budget etc).

Preferred candidate profile

• M.Pharm/ B.Pharm / MSc ; Experience- 18 to 25 years
• Candidate Must have exposure of regulatory Audits
• should be willing to relocate with family to ahmedabad