Quality Oversight Specialist

From 1 to 2 years

The required education for the job is:

Bachelor's Degree

• Monitoring and implementation of programs, procedures, and practices in areas intended for the manufacture of medications by aseptic filling, under the criteria of compliance with GMP and ROVI internal policy.
• Supervision of good practices in the production plant under the criteria of compliance with GMP.
• Monitoring of material sterilization processes and control of equipment use under current qualification guidelines, monitoring of cleanliness of areas and equipment, and monitoring of personnel gowning procedures.
• Supervising, in person or remotely, the aseptic filling validation processes of the production plant.
• Reviewing media fill events, in person or remotely, through video review.
• Monitoring of aseptic practices and CCS, with participation in meetings and work sessions as established.
• Drafting, reviewing, and approving procedures related to pharmaceutical activity in general (manufacturing, quality, etc.) under the criteria of compliance with GMP and ROVI internal policy.
• Providing or participating in personnel training related to quality criteria in pharmaceutical operations.
• Participation in audits, collaborating with quality criteria aligned with EU GMP and reference guidelines.
• Notifying higher positions of potential compliance risks detected during routine functions and proposing improvements regarding them.
• Implementing and closing CAPAs and CHCs for which responsible, within the estimated timeframe.
• Walkthroughs of the production plant, reporting observations and creating an oversight panel.
• Technical assistance, monitoring, review, and active collaboration in resolving incidents or deviations that could lead to alterations or risks to the quality, safety, and efficacy of medications.
• Sampling and analysis of commercial units for inspection of quality defects (AQL).

Temporary (fixed-term)