Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

SCOPE OF THE POSITION/RESPONSIBILITIES:

Assure that the pharmaceutical production of sterile injectables follows current regulations (US and EU GMP) and company quality standards via prevention, constant control, and improvement interventions.

SPECIFIC TASKS/PRIMARY ACTIVITIES:

Supervision

Continuously lead all aspects of the production lines of sterile forms (cleaning, mix-up, operation, defects) to ensure that all processes adhere to the latest regulations and maintain the quality standards of the company.

Quality

Assist in coordinating and leading all aspects of machinery testing and validation tasks, ensuring compliance with existing regulations and the quality criteria set by the company.Participate in the execution of self-audits and in the implementation of any corrective actions in compliance with current regulations and company quality standards.Participate in the analysis and definition of actions striven to remove the causes of defects and complaints.Based on the results of controls and monitoring, propose GMP training courses suitable for production activities and take part in them as a trainer.

Procedures

Contribute to the creation and editing of procedures and processing sheets, verifying their usage in operations.

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RELATIONSHIPS:

INTERNAL

QA/QCTechnology TransferWarehousesAll department headsEngineering

EXTERNAL

Suppliers of machinery and systems

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REQUIREMENTS AND QUALIFICATIONS:

 (a) Essential:

Studies/Diplomas/Training courses:Diploma with validated experience or degree

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Technical and IT knowledge:Knowledge of machinery, equipment, and methodologies for the production of drugsIn-depth knowledge of GMP regulationsKnowledge of the problems related to aseptic productionAbility to use the main information systems

 

Professional experience:Consolidated experience in QA/Production in pharmaceutical companies

 

Languages:English

 

Personality traits:TidinessObservation skillsRelational skillsCritical thinking

 

(b) Desirable:

Experience in manufacturing sterile injectable drugs and oral drugs