Catalent is looking for a Senior QA Technical Reviewer to ensure the quality and compliance of technical documents related to process improvement, equipment validation, product validation, and maintenance for their St. Petersburg facility.
Requirements
- Prior experience working with technical review, investigation writing, including root cause analysis and report writing is a must.
- Proficient to Advance knowledge of Microsoft programs required (Excel, Word, Access and PowerPoint).
- Experience with Documentum, TrackWise, and JD Edwards is preferred.
- Must possess solid technical expertise as it relates to manufacturing processes, decision-making skills, and the ability to solve problems with minimal guidance.
- Ability to identify root cause of problems and offer solutions, which address causes, rather than symptoms.
- Working knowledge of cGMPs and/or OSHA regulations required.
- Ability to work effectively under pressure to meet deadlines.
Responsibilities
- Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production.
- Reviews and approves technical documents, such as: Technical Protocols and Reports, Process Validation Protocols and Reports, Cleaning Validation Protocols and Reports, IQ/OQ/PQ Protocols and Reports and, Change Control, as it pertains to the above validated/qualified systems.
- Reviews and approves deviation investigations with particular attention to suggested root cause and CAPA to ensure appropriate actions are identified to prevent occurrence/reoccurrence
- Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs and regulatory guidelines).
- Approve documents as designated by QA management.
- Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities.
- Provide QA Technical recommendations based on trend analysis to eliminate future problems.
Other
- Bachelor’s degree in Science or Engineering with minimum of 3 years of related experience in QA pharmaceutical manufacturing and/or Manufacturing pharmaceutical operation.
- Proficient (excellent) English verbal and written communication skills to communicate with all levels of the organization in various functional areas and receive ideas and instructions to/from others within and outside the organization and effectively present information and respond to questions from site management.
- Ability to work in a cross-functional team environment.
- Proven ability to multi-task and demonstrate diplomatic skills.
- Individual required to sit, stand, walk and lift 0-15 pounds; no lifting greater than 44.09 pounds without assistance.
