Job Description

Division

Department

Sub Department 1

Job Purpose

Operate & maintain packing machines to achieve quality product & shift wise targeted output with maximum utilisation.

Key Accountabilities (1/6)

Prepare the machine for packing operation as per production plan by using proper resources to ensure smooth operations

• Perform calibration, clean and set different equipment and machines as per SOP and schedules for on-time completion of batch processing
• Check the suitable change part as per product requirement
• Arrange change parts & stereo for batch packing activity

Key Accountabilities (2/6)

Operate the packing machines by using minimum resources to get quality product

• Evaluate the product dimensions and set the machine for changeovers
• Perform in-process checks in packing machines to ensure proper functioning of machine
• Perform labelling and handle rejection control in packing machine
• Reduce micro stoppages and avoid non-conformances during packing machine operations, cleaning and line clearance
• Maintain equipment, facility and block premises as per SOP for audit readiness and to avoid critical and major observation
• Perform all operations as per cGMP and safety to reduce rejection

Key Accountabilities (3/6)

Execute and update online documentation to meet cGMP requirements and maintain data integrity Fill Machine logs. Document entries/SOP and process simplification to meet cGMP.

• Fill Machine logs & other relevant documents precisely to meet cGMP requirements
• Check documentation before submission to ensure data integrity
• Conduct training related to cGMP, equipment operation, for workmen to minimize deviation from procedure
• Provide technical support to operators about packing activity and cGMP to get quality output for any up-gradation during packing activity

Key Accountabilities (4/6)

Perform packing machine operations safely to avoid safety incidences by appropriately handling the machines and thereby maintaining high standard of safety

• Perform regular interlock checks of packing machines and perform safe operations
• Ensure usage and maintenance of PPEs by workmen during shifts
• Report any near-miss to officer in-charge in time

Key Accountabilities (5/6)

Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations

• Provide training to other operators about secondary packing machine settings and operations
• Conduct training related to safety and housekeeping for workmen
• Participate in learning of new machine and build expertise in troubleshooting the machines

Key Accountabilities (6/6)

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
• Low yield due to more rejections. Overcome by controlling rejection and simplification of process and attending training

Key Interactions (1/2)

• Store for daily dispensing plan and availability of packing materials (Daily basis)
• Engineering for preventive maintenance and help in modification (as per need)

Key Interactions (2/2)

Maintenance contractor for any machine repairs (Need Based)

Dimensions (1/2)

• Achieve average volume of 60 mn (FY2015-16)
• Average number of BPR’s handled : 60
• Average number of batches in packing : 60
• Average number of sales order dispatched : 25
• 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)

• 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

Key Decisions (2/2)

Education Qualification

Diploma (Engineering / Pharmacy)

Relevant Work Experience

0-2 years of experience in packing with knowledge of handling of QMS activity, qualification and other related documents