About this role
Division
Department
Sub Department 1
Job Purpose
Monitor and execute the production activities in an area during the shift by maintaining cGMP and safety norms to achieve production targets
Key Accountabilities (1/6)
Execute production activities in a shift by managing available resources to achieve production target
- Execute assigned tasks as per planned production activity to meet production targets for a shift
- Regulate usage of consumables in the production process at optimum levels to save costs
- Increase the efficiency of area by utilization of equipment and by reducing downtime in manufacturing area
Key Accountabilities (2/6)
Maintain standard process parameters as per BMRs and other supporting documents for achieving production target and maintaining quality
- Ensure all operations are performed as per GMP & Safety norms by reviewing all processes and documents for compliance
- Ensure equipment, facility and block premises are maintained as per regulatory compliance
- Maintain system integrity by updating documentations and deviations on CipDox while performing operations
- Perform validation, qualification and calibration as per schedule and update output of all activities in the systems
- Prepare new documents and update existing documents as per GMP requirement
Key Accountabilities (3/6)
Prepare manufacturing records and update online documentation to meet production and cGMP requirements
- Maintain online documentation and timely entries in BMR and supporting documents
- Prepare new documents and update existing documents as per GMP requirement
- Operate software such as SAP, CipDox and QMS
Key Accountabilities (4/6)
Follow safe work processes and ensure safety appliances are utilised during production activities in shifts to create a safe working environment
- Ensure safety systems and procedures followed by the operators in the shift
- Ensure availability and usage of PPEs in the shift by coordinating with HSE department for requirements and shift schedule
Key Accountabilities (5/6)
Execute production activities in a shift by managing available resources to achieve production target
- Execute assigned tasks as per planned production activity to meet production targets for a shift
- Regulate usage of consumables in the production process at optimum levels to save costs
- Increase the efficiency of area by utilization of equipment and by reducing downtime in manufacturing area
Key Accountabilities (6/6)
Major Challenges
- Meeting shift targets due to unavailability of adequate resources. Overcome by efficient work load distribution and resource optimisation
- Meeting production targets due to lapses in knowledge transfer between shifts. Overcome by bridging gaps between inter-shift communication
- Maintaining cGMP requirements during system downtime. Overcome by coordinating with the engineering team and technical support team
Key Interactions (1/2)
- QA/QC for scheduling of batches, issues in product (Daily)
- Engineering & Utility for system related queries (Daily)
- Formulation Technical Support for troubleshooting in products (Case Basis)
- Formulation Technology Transfer for support in new products (Project Basis)
- Stores and Warehouse for RM/PM related activities (Daily)
- Safety for safety rounds and PPE requirement (Daily)
Key Interactions (2/2)
- Maintenance Contractor and vendors for any machine repairs and spares (Case Basis)
- Equipment manufacturer: For troubleshooting in machine (Case Basis)
Dimensions (1/2)
- Direct Reports : 12 (dotted reporting in shift)
- Number of areas managed : 3
- Number of dosage forms : 2
- Number of tech transfer supported per month : 2
- Number of batches executed per month : 35-40
- Achieve internal OTIF more than 90%
- YOY improvement in shift operations efficiency
- Achieve Zero reportable accidents / incidences during manufacturing
- Achieve set target for batch failure reduction
- Achieve 0% errors in online documentation
- Meet 100% compliance to SOP and safety regulations
Dimensions (2/2)
Key Decisions (1/2)
- Resource allocation for each shift
- Workload distribution in each shift
Key Decisions (2/2)
- Up-gradation in Facility and Documents (To Section Head)
- Modification in plant and equipment (To Section Head)
- Deviation and implementation of CAPAs (To Section Head)
Education Qualification
Bachelor in Pharmacy
Relevant Work Experience
- 3-4 years of experience with 2 years of experience in pharmaceutical manufacturing
- Knowledge of cGMP practices, equipment operations required for Formulation Production