Senior Operator Production

InvaGen Pharmaceuticals Inc; Rangpo; On-site; INR 300,000 - 520,000; Full time

Job summary

InvaGen Pharmaceuticals Inc. is seeking a Production Operator to execute production operations on a shift basis while upholding safety and cGMP requirements. You will operate equipment per SOP, maintain documentation, and support process improvements.

The ideal candidate has 1–3 years of experience in pharmaceutical manufacturing and a Diploma in Pharmacy or Mechanical, with a focus on accuracy, teamwork and compliance.

Qualifications

• Diploma in Pharmacy or Mechanical required.
• 1-3 years of experience in a manufacturing organisation, preferably in pharmaceutical industry.

Responsibilities

• Operate equipment efficiently without error and deviation as per SOP to meet shift targets.
• Maintain online documentation and timely entries in BMR and supporting documents.
• Conduct training related to cGMP, equipment operation, safety and housekeeping for workmen.
• Ensure usage and maintenance of PPEs by workmen during shifts.
• Report any near-miss to officer in-charge in time.

Skills

cGMP knowledge

Documentation

Safety compliance

Education

Diploma in Pharmacy / Mechanical

Job description

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

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

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

1-3 years of experience in a manufacturing organisation preferably in pharmaceutical industry