Oxford Global Resources is looking for a qualified pharmaceutical professional for a 100% remote position- Janssen project.
The Deviation Approver/Reviewer will provide support to meet the batch record review/disposition schedule and to adhere to manufacturing lot release dates. This position is responsible for, executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records.
- Initiates Quality Records and conducts deviation investigations that meeting both Industry and client expectations.
- Leads or manage investigations including root cause analysis and assesses product impact using input from various departments and various tools.
- Develops executes and oversees CAPAs.
- When CAPA are required, provides guidance to the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements.
- Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
- Supports Tech transfer and process monitoring support as needed.
- Collaborates with cross-functional investigation teams on department-specific trend deviations.
- Provides guidance to the investigation team for performing a deep-dive analysis of department-specific trends, to include:
- Revision and management of manufacturing documents such as Batch Records and SOPs.
- Leads or supports Continuous Improvement projects.
- Conducts data gathering, trending, and data presentation as needed to support investigations.
- Responsible for real-time, on the floor response in support of operational deviations by gathering information and completing an initial event report.
- Evaluates the application of human and organizational principles to investigations.
- Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers.
- 5+ years of experience in execution and/or approval of deviation investigations.
- Expertise in a quality assurance or technical role within a GMP manufacturing environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
- Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology, pharmaceutical, and manufacturing industries.
- Experience with using complex root cause analysis (RCA) tools and methodologies.
- Experience with using quality risk management principles.
- Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
- Demonstrated excellence in technical writing.
- Temporary position: 6 months renewable
- 100% remote position
- Salary: Very attractive and competitive- according to the skills and experience of the candidate
- Starting Day: ASAP
- Location: Remote