Department: Azzur Worcester, LLC
Azzur is a GxP consulting organization dedicated to providing high quality, expertly backed assistance that drives pharmaceutical, Biotechnology and Medical Device companies to success. We are seeking highly motivated and talented individuals to join our incredible team.
Essential Duties and Responsibilities
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.
- Development and review of technical documentation including:
- Standard Operating Procedures
- User Requirements and Design Specifications
- Commissioning and Qualification Protocols
- Execution of validation test procedures
- CAPA and Change Management
- Thermal mapping of Autoclaves and SIP processes
- Technical report writing
- Data Analysis
- P&ID walkdowns
- Performs/executes/validation/verification studies (FAT, SAT, CTP, IQ, OQ, PQ) for cleaning, sterilization, equipment, systems, utilities, and processes for qualification/verification and/or re-qualification/re-verification.
- Prepare and review SOPs and other documents for compliance and provide guidance and counsel to staff as needed.
- Evaluate processes, propose solutions resolve issues and communicate results to support project/task completion.
- Develop and complete deliverables related to QA activities as needed to ensure objectives are met.
- BS in Engineering, Science or equivalent technical degree.
- Experience in validation and/or Quality in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong communication, interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast paced multitasking environment.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- In-depth understanding of various FDA regulations/guidance including 21CFR Part 11
- Ability to travel to client sites throughout the New England region.