Three Sixty Five Business Consultancy

Introduction

The Three Sixty Five Business Consultancy is seeking Production Operators II and III with experience in OSD/Solid Dose Pharmaceutical Manufacturing. The Production Operators will be responsible for performing functions related to the processing of drug products, ensuring compliance with cGMP standards and SOPs.

Responsibilities

• Operating pharmaceutical production machinery for processes like weighing, blending, granulation, compression, encapsulation, coating, etc.
• Executing written SOPs to maintain product purity
• Cleaning manufacturing equipment according to SOPs
• Executing machine changeovers from batch to batch
• Completing documentation associated with manufacturing processes accurately
• Assisting in troubleshooting process issues
• Adhering to cGMP compliance and regulatory requirements
• Participating in safety teams and discussions
• Conforming to all training requirements
• Collaborating within the team and cross-functional units

Requirements

Required Skills & Abilities:

• Proficient in running machinery
• Proficient in equipment cleaning
• Proficient in sampling batches
• Proficient in basic set-ups
• Ability to participate in Continuous Improvement projects
• Qualified in at least one of the following manufacturing processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Potent Compound

Experience & Education:

High School Diploma or equivalent experience

2-5 years of pharmaceutical manufacturing experience for Level II Operator

5+ years of pharmaceutical manufacturing experience for Level III Operator

Knowledge of Good Manufacturing Practices (cGMP)

Knowledge & Skills:

• Strong background in solid dose manufacturing specific to Compression, Encapsulation, Coating, or Wurster Coating
• Experience in Pharmaceutical Granulation and Blending
• Knowledge of FDA regulations, GMP, Lean Manufacturing, Six-Sigma, etc.
• Basic math, reading, legible writing skills

Physical Requirements/Working Environment

Must be able to stand for long periods, maneuver at least 50 pounds, wear required PPE, and pass respirator tests. Travel may be required.

Disclaimer

The above information is a general overview of the position. It is not a comprehensive inventory of all duties, responsibilities, and qualifications. Minimum 3-7 years OSD/Solid Dose Manufacturing experience is mandatory.