Job Description

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