- Researches, expedites, solves, and tracks manufacturing discrepancies and resulting commitments within the Drug Product Primary Processing Unit (PPU) or assignment.
- Initiates Manufacturing Investigation Reports (MIR) and coordinates the actions required for resolution.
- Works closely with Operations and Quality Assurance, ensuring that all investigations are performed according to corporate and site guidelines.
- Ensures that Manufacturing Investigations accurately identify all processing and manufacturing deficiencies to determine and classify root cause
- Gathers, coordinates, and reviews validation & batch documentation, standard operating procedures, testing and manufacturing specifications, testing results, training & calibration records, regulatory & site/corporate policies
- Sets realistic objectives and clearly assigns accountability for tasks and decisions
- Writes clear, concise summaries of manufacturing investigations, product impact assessments, and commitments
- Provides solutions for potential and identified problems
- Tracks, trends, and evaluates manufacturing discrepancies and works to eliminate root causes
- Participates in decisions regarding Manufacturing Investigations as to situation review/cause analysis and potential batch impact
- Works closely with the Operations and Quality Assurance Groups. Based on the scope of the investigation, the Investigator may also be required to coordinate activities with various support groups including Technical Services, Engineering/Maintenance, Regulatory Affairs, and the Quality Control Laboratory
Must have Bachelor of Science degree with 3-5 years of pharmaceutical manufacturing experience and at least 2 years in a laboratory, manufacturing or quality assurance environment. Strong technical writing background required. Excellent verbal/written communication skills are essential. Must have good attention to detail, problem solving skills, and the ability to manage multiple priorities. GMP Manufacturing/Aseptic Processing experience is a must. One to three (1-3) years of experience in Quality Control and Quality Assurance desired.
Synectics is an Equal Opportunity Employer.
JobServe USA - 22 months ago