QA Operations

Profile:

• Masters’ degree in Pharmacy, Chemistry, Biotechnology, Biochemistry, Chemical Engineering, or equivalent
• GMP knowledge
• FDA experience preferred
• Process engineering and pharmaceutical production experience
• Minimum 2 years of work experience in the pharmaceutical industry, particularly in quality assurance related fields.
• Batch record Review experience
• Knowledge of Data Integrity principles and Risk Management tools
• Analytical skills, proactive and creative personality
• Ability to multi-task, work independently, be self-directed and organized
• Comfortable working in a fast-paced and dynamic work environment
• Team working and multi-disciplinary approach ability
• Good communication skills
• Good English level (written and oral)

Main Responsibilities:

• Implement and enforce Quality Management System application in the context of more complex projects (e.g. chromatography, Sterile DS/DP), assuring that production operations are clearly defined and implemented, and that each batch is produced and controlled in accordance with the requirements of the Good Manufacturing Practice

• Work with Project Managers, in the context of complex projects, to define and approve production processes, final product specifications and documentation according to Quality Management System, as well as final product analysis, communicate with clients and make decisions on how to ensure conformity with the defined guidelines and Quality Agreements

• Analyse Deviations and Out of Specification (OOS), ensuring an investigation is conducted to find out their root causes, and that their impacts on the product/ project are evaluated and reported, taking measures to anticipate, prevent and correct them

• Define corrective and preventive actions in projects to address non-conformities and enforce guideline follow through, including discrepancies, reprocessing and rework procedures

• Revise projects and production operations’ reports and documentation to verify if the production process followed internal procedures and Good Manufacturing Practice, and forward conclusions to the Qualified Person.

• Ensure, in close collaboration with QA Systems’ team, the revision and approval of Standard Operating Procedures (SOPs), so that they are duly issued and their last version is available and at use.

• Supervise the revision and approval decision of new or edited documents related with internal policies, procedures, work instructions, protocols, test methods and specifications, following the procedures in place

If you want to join us and be part of a unique Team that works on a daily basis to make a positive difference in people life´s, send your application to joana.moura@genibet.com