Senior Officer - Production

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