Address
Form of work Responsibilities:
- Develops a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps.
- Provides consistent direction and ensures timely completion of deviation investigations to ensure ongoing consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with Manufacturing and Quality teams.
- Collaborates with other leaders across the organization and assists in the continuous improvement and life cycle management of implemented GMP policies and quality management systems.
- The investigation owner will lead the investigation of deviations that occur in operations. Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports.
- Partners with quality assurance, quality control, operations, engineering, maintenance, calibration, safety, and supplier quality management to ensure the appropriate and timely determination of scope, product impact, root cause, and corrective actions.
- Determines scope, product impact, root cause, and corrective actions for deviations from procedures. Proposes and implements effective CAPA to eliminate these causes.
- Determines appropriate preventative actions to prevent reoccurrence of the deviation, author's deviations, and conducts personnel interviews to determine the root cause of the deviation.
- Update SOPs or other official documents as required.
- Provide a positive and equitable working environment emphasizing client's values.
- Completes any other duties/responsibilities assigned by senior management.
- 2-5 years of related experience in a cGMP regulated manufacturing pharmaceutical environment and /or QA/QC preferred.
- Technical writing experience, writing deviations, and CAPAs in the pharmaceutical/biotech industry. Experience with deviation or investigation management systems.
- Relevant industry biotechnology manufacturing and/or quality operations experience. Ability to author and review standard operating procedures, on-the-job trainings, and other controlled documents.
- Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report.
- Proficient in Deviation Management (i.e. TrackWise). Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment. Proficient in the use of the following methodology: 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, Human Error Reduction.
- Bachelor's degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or equivalent experience.
