Job Description

Reporting to: Production Manager

Job Purpose: Providing best practice day-to-day manufacturing pharmaceutical services to manage work flow, production and Document Procedure Compliance so as to ensure safe and efficacious medicines are manufactured. To comply with cGMP, MCC guidelines, SOPs and adhere to batch documentation instructions at all the times.

Required Learning

B. Pharm Degree

• Registered with South African Pharmacy Council
• 1-2 years' experience in Pharmaceutical Production in a Manufacturing environment
• Knowledge of cGMP
• Computer Literacy MS Office (proficient in Excel, Word and Power Point)

Key Job Outputs

Proper documentation of manufactured and packaged pharmaceutical products

• Perform Line Openings and Closures in manufacturing & packing lines
• Prepare weekly production scheduling of product
• Auditing batch documents for QA closure and release
• Assist in preparing Annual Product Quality Reviews

• Initiate and close off Deviations, CCP and CAPAs.
• Ensure regulatory compliance Safety, Health and Environmental Standards.
• Manufacturing process including line checks
• Regulatory & Document Compliance
• Handling of non-conforming production, both inbound, WIP and produced batches
• Audits & Continuous Improvement
• Development of Teams technical capabilities
• Lead / Champion change overs, line opening, line closing,
• Lead and be the chief accountable officer for GMP and Micro compliance in the area on shift
• On line and in line testing resulting in approval of batch documentation and Provisional releases
• Submission of full production manufacturing tickets and supporting documentation within one hour of batch completions
• Ability to identify, execute and prioritize work tasks/projects
• Excellent interpersonal, communication skills and team oriented
• Strong problem solving and troubleshooting capabilities

Core Competencies

Analysing

• Deciding and Initiating Action
• Delivering Results and Meeting Customer Expectations
• Planning and Organising
• Writing and Reporting
• Applying Expertise and Technology
• Coping with Pressure and Setbacks
• Achieving Personal Work Goals and Objectives
• Adhering to Principles and Values
• Relating and Networking
• Presenting and Communicating Information
• Working with People

Metamorphosis Integrated Solutions