Quality Specialist
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 OfficeJob 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.
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
Required Experience:
Unclear Seniority
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
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