Junior Officer - Packing

InvaGen Pharmaceuticals Inc; Rangpo; On-site; INR 250,000 - 350,000; Full time

Job summary

InvaGen Pharmaceuticals Inc. in India seeks a Packing Technician to monitor and perform packing activities in a shift while maintaining cGMP and safety.

You will review and update documentation in SAP and CipDox, ensure use of consumables, and support production targets.

The role requires 1-5 years in packing and a B.Pharm/B.Sc in chemistry; the company offers growth and a collaborative environment.

Qualifications

• Experience in packing with knowledge of handling of QMS activity and related documents.
• B. Pharm. / B. Sc. (Chemistry) degree required.
• 1-5 years of relevant packing experience.

Responsibilities

• Execute shift packing activity by managing resources to meet shift targets.
• Review documentation and monitor packing parameters per BPR to ensure regulatory compliance.
• Review in-process parameters like NFD, camera challenge, RH temperature; ensure GMP compliance.
• Maintain online documentation and update SAP and CipDox records.
• Prepare manufacturing records and update documents for GMP requirement.
• Provide training to staff for packing activities and safety procedures.

Skills

QMS knowledge

Documentation

GMP compliance

Education

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

Tools

SAP

CipDox

Job description

Job Description:

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 (FY2015-16)
• 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

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

Requirements: