Job Description

Division

Department

Sub Department 1

Job Purpose

Execute the production operations in line with safety and GMP requirements to meet the manufacturing targets in shift.

Key Accountabilities (1/6)

Operate the equipment efficiently without error and deviation as per SOP to meet shift targets

• Perform unit operations as per SOP and unit processes as per batch manufacturing record
• Optimize the utilization of available resources for achieving production in shift
• Maintain equipment, facility and block premises as per SOP for audit readiness

Key Accountabilities (2/6)

Provide suggestions for optimization of processes to manufacture quality product

• Identify the deficiency in area and errors in documents and rectify them as per requirement
• Propose and implement new idea to enhance production, optimise the use of consumable goods and maximum utilization of resources

Key Accountabilities (3/6)

Execute and update online documentation to meet cGMP requirements

• Maintain online documentation and timely entries in BMR and supporting documents
• Check documentation before submission to ensure data integrity

Key Accountabilities (4/6)

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

• Conduct training related to cGMP, equipment operation, safety and housekeeping for workmen
• Optimize the use of resources in housekeeping
• Ensure good housekeeping and sanitisation as per the guidelines
• Ensure usage and maintenance of PPEs by workmen during shifts
• Report any near-miss to officer in-charge in time

Key Accountabilities (5/6)

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

Key Interactions (1/2)

• Engineering & Utility for system and equipment related queries (Daily)
• Safety for safety rounds and PPE (Weekly)
• Formulation Technical Support for troubleshooting in products (Case Basis)

Formulation Tech Transfer for support in new products (Project Basis)

Key Interactions (2/2)

• Equipment manufacturer for troubleshooting in machine (Case Basis)

Dimensions (1/2)

• 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%
• Meet percentage utilisation of plant as per the plan
• 0% errors in documentation
• Zero reportable accidents / incidences during manufacturing
• Achieve 0% failures / deviations target

100% compliance to SOP

Dimensions (2/2)

Key Decisions (1/2)

Scheduling house-keeping activities

Key Decisions (2/2)

• Equipment Selection to Section Head
• Modification in plant and equipment to Production Officer

Education Qualification

Diploma in Pharmacy / Mechanical

Relevant Work Experience

0-2 years of experience in a manufacturing organisation preferably in pharmaceutical industry