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