Responsible for supporting Manufacturing with investigations of deviations, complaints, excursions, OOS results, and change controls. Responsible for determination of root cause and initiation of corrective/preventative actions designed to adequately address and correct the related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat events. The position requires working both in a team and as an individual contributor with minimal supervision to manage assigned investigations from initiation to completion.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing, and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation has on the product, process, and patient health and safety.
- As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.
- Prepares and analyzes data, using root-cause analysis tools to determine root causes and effectively communicates the root cause to management.
- Properly assesses the Manufacturing environment, independently conceives and advises management on appropriate corrective/preventative actions designed to mitigate operational deficiencies identified in the investigative process using industry accepted analytical tools.
- Assesses processes for change management and generates change controls with appropriate actions, considering impact to validated systems, current drug products, and patient health and safety.
- Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.
- Works cross-functionally with other teams within the Canton site as needed to complete investigations.
- Demonstrates strong technical skills; provides technical assistance to area supervisors or managers to solve complex problems.
- Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.
- Perform any other tasks/duties as assigned by Management.
- BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience.
- At least one year of experience in an FDA regulated, GMP manufacturing environment. Experience writing standard operating procedures, protocols, reports, and deviations preferred.
- Good organizational skills and deductive critical thinking skills required.
- Advanced writing skills required.
- Proficient in MS Office programs, including Word and Excel.
- Candidate must possess strong interpersonal, written, and verbal communication skills. Incumbent must be able to interface positively with team members, company departments, and vendors.
- Prefer candidates proficient with software programs TrackWise and Documentum.
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.