Quality Specialist

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, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Descrizione impiego

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.

RELATIONSHIPS:

INTERNAL

• QA/QC
• Technology Transfer
• Warehouses
• All department heads
• Engineering

EXTERNAL

• Suppliers of machinery and systems

REQUIREMENTS AND QUALIFICATIONS:

(a) Essential:

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

• Technical and IT knowledge:
• Knowledge of machinery, equipment, and methodologies for the production of drugs
• In-depth knowledge of GMP regulations
• Knowledge of the problems related to aseptic production
• Ability to use the main information systems
• Professional experience:
• Consolidated experience in QA/Production in pharmaceutical companies
• Languages:
• English
• Personality traits:
• Tidiness
• Observation skills
• Relational skills
• Critical thinking

(b) Desirable:

• Experience in manufacturing sterile injectable drugs and oral drugs

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