Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support the ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
• Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; ensures procedures comply with policy and make sense.
• Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
• Auditing of commissioning and validation documentation.
• Develops... product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA's.
• Develops and implements statistical quality programs and process monitoring systems.
• Bachelor's degree, preferably in Biology, Chemistry or Engineering
• 4+ years of overall experience in Manufacturing, Quality or Engineering
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing
Heredia Province Heredia Costa Rica

Salary Criteria