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

Junior Operator - Production