Shift In-charge - Production

InvaGen Pharmaceuticals Inc; Rangpo; On-site; INR 600,000 - 900,000; Full time

Job summary

InvaGen Pharmaceuticals Inc. in India is seeking a seasoned production professional to oversee shift activities, ensure cGMP and safety compliance, and drive achievement of production targets in formulation production.

You will manage resources, operate formulation equipment, and maintain accurate online documentation with SAP, CipDox and QMS tools. Bachelor in Pharmacy with 5-6 years of experience (2-3 years in pharma manufacturing) is required.

Qualifications

• Bachelor in Pharmacy
• 5-6 years of experience with 2-3 years in pharmaceutical manufacturing
• Knowledge of cGMP practices and equipment operations required for Formulation Production
• Experience with SAP, CipDox and QMS for documentation and compliance

Responsibilities

• Monitor production activities in a shift by managing available resources to achieve production target
• Monitor planned production activity to meet production targets for a shift; utilise shift resources optimally
• Regulate usage of consumables to save costs
• Maintain standard process parameters and ensure GMP & safety compliance
• Update documentation and deviations; perform validation, qualification and calibration as scheduled
• Conduct training on equipment handling, unit operations, cGMP for operating staff
• Prepare and update manufacturing records and SOPs as per GMP requirements
• Operate software such as SAP, CipDox and QMS
• Ensure safe work practices and PPE usage during production shifts

Education

Bachelor in Pharmacy

Tools

SAP

CipDox

QMS

Job description

Job Description:

Division

Department

Sub Department 1

Job Purpose

Monitor the production activities in a shift by maintaining cGMP and safety norms to achieve production targets

Key Accountabilities (1/6)

• Monitor production activities in a shift by managing available resources to achieve production target
• Monitor planned production activity to meet production targets for a shift Utilise shift resources optimally to get desired production output
• Regulate usage of consumables in the production process at optimum levels to save costs

Key Accountabilities (2/6)

• Maintain and monitor standard process parameters as per BMRs and other supporting documents for achieving production target and maintaining quality
• Ensure all operations are performed as per GMP & Safety norms by reviewing all processes and documents for compliance
• Ensure equipment, facility and block premises are maintained as per regulatory compliance
• Maintain system integrity by updating documentations and deviations on CipDox while performing operations
• Perform validation, qualification and calibration as per schedule and update output of all activities in the systems
• Conduct training related to equipment handling, unit operations, unit processes, documentation, cGMP for operating staff
• Participate during the preparation of SOPs, FMECA (risk analysis) and submit for review
• Prepare new documents and update existing documents as per GMP requirement

Key Accountabilities (3/6)

• Prepare manufacturing records and update online documentation to meet production and cGMP requirements
• Maintain online documentation and timely entries in BMR and supporting documents
• Prepare new documents and update existing documents as per GMP requirement
• Operate software such as SAP, CipDox and QMS

Key Accountabilities (4/6)

• Ensure that safe work processes are followed and safety appliances are utilised during production activities in shifts to create a safe working environment
• Ensure safety systems and procedures followed in the shift
• Ensure availability and usage of PPEs in the shift by coordinating with HSE department for requirements and shift schedule
• Ensure compliance to safety training targets by monthly reconciling attendance records

Key Accountabilities (5/6)

• Identify the deficiencies/errors and propose new ideas and suggest improvements to reduce the complexity in processes
• 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 (6/6)

Major Challenges

Key Interactions (1/2)

Key Interactions (2/2)

Dimensions (1/2)

Dimensions (2/2)

Key Decisions (1/2)

Key Decisions (2/2)

Education Qualification

Bachelor in Pharmacy

Relevant Work Experience

5-6 years of experience with 2-3 years of experience in pharmaceutical manufacturing Knowledge of cGMP practices, equipment operations required for Formulation Production

Requirements: