Junior Officer

Division
Department
Sub Department 1
Job Purpose
Monitor and execute the packing activities in a shift by maintaining cGMP and safety norms to achieve production targets

Key Accountabilities (1/6)
Execute shift packing activity by managing available resources and reduces micro stoppage of machine to achieve shift target

• Utilise shift resources optimally to get desired production output

Regulate usage of consumables in the production process at optimum level to save cost

Key Accountabilities (2/6)
Review documentation related to packing activity and monitor standard packing parameters as per BPR to meet regulatory requirement

• Review and monitor critical in-process parameters like NFD, camera challenge, RH temperature etc.
• Review and perform all operations as per GMP and safety norms by reviewing all processes and documents for compliance
• Maintain system integrity by updating online documentation

Perform qualification and calibration of equipment as per schedule and update output of all activities in the system

Key Accountabilities (3/6)
Prepare manufacturing records and update online documentation to meet production and cGMP requirement

• Maintain online documentation and timely entries in BPR and supporting documents by operating SAP and CipDox

Prepare new documents and update existing documents as per GMP requirement

Key Accountabilities (4/6)
Monitor adherence to safety guidelines in the block during a shift for packing activities to create safe working environment

• Monitor safety systems and ensure procedures are followed in shift and near-miss cases are reported to HSE timely
• Ensure availability and usage of PPEs in the shift by coordinating with HSE department

Ensure compliances to safety training targets by monthly reconciling attendance records

Key Accountabilities (5/6)
Provide training to staff & workmen for packing activity by regular interactions with them to get quality product

• Provide training to staff and daily workers for packing activities and safety procedures

Conduct training related to equipment handling, cGMP, documentation and unit operations

Key Accountabilities (6/6)
Provide new ideas and simplify processes to reduce process cycle time and achieve new targets

• Provide new ideas during idea sessions for better productivity with minimum cost
• Identify the complexities and suggest process simplification areas to achieve new target with optimum utilization of resources

Reduce and simplify documentation for better accuracy and to meet ALCOA (Attributable Legible Contemporaneous Original Accurate)

Major Challenges

• Meeting shift target due to unavailability of adequate resources. Overcome by efficient work load distribution

Maintaining cGMP requirements during system downtime. Overcome by coordinating with engineering and technical support team

Key Interactions (1/2)

• Quality assurance and control for batches release as per packing plan (Daily)
• Engineering for preventive maintenance and help in modification (as per need)
• Safety for awareness training and near miss issue (Daily)

Store
for daily dispensing plan and availability of packing materials (Daily basis)

Key Interactions (2/2)
Maintenance contractor
for any machine repairs (Need Based)

Dimensions (1/2)

• Direct Reports : 3
• Achieve average volume of 200 mn (FY
• Average number of BPR's handled : 200
• Average number of batches in packing : 200
• Average number of sales order dispatched : 80
• Achieve internal OTIF more than 90%
• Achieve Zero reportable accidents/ incidences during packing activities
• Achieve 0% errors in online documentation

Meet 100% compliance to SOP and Safety regulation

Dimensions (2/2)
Key Decisions (1/2)
Resources allocation and work distribution for each shift

Key Decisions (2/2)

• Up-gradation in facility and documents to Section Head - Packing
• Modification in equipment to Section Head - Packing

Deviation and implementation of CAPAs Section Head - Packing

Education Qualification
B. Pharm. / B. Sc. (Chemistry)

Relevant Work Experience
1-5 years of experience in packing with knowledge of handling of QMS activity, qualification and other related documents