Sr. Quality Assurance Consultant – GxP Systems and Applications
The Quality Engineer delivers validation of biopharmaceutical manufacturing computer systems and laboratory instruments and ensures the department maintains and continuously improves its state of GMP compliance. They will be responsible for performing qualification and validation activities in a multi-product biotech manufacturing facility and owning records (deviations, CAPAs, Change Control) within the quality systems.
Duties & Responsibilities:
- Lead/manage validation projects including:
- Provide risk assessment for new systems and changes to existing systems
- Write validation plans, protocols and reports
- Execute and provide reviews of validation protocols and validation periodic monitoring
- Lead or participate in project team including the supervision of validation contractors
- Provides estimates of validation resource requirements.
- Owning Quality Systems Records
- Create and own and manage life cycle of deviations, corrective actions and change controls for GxP systems and applications (including Osi Pi, Trackwise, SumTotal, etc)
- Operate within the relevant quality computer systems (ex. SAP) ensuring implementation in line with quality and timeliness objectives
- Working closely with Quality, Process Development, Validation, and Manufacturing to investigate and resolve deviations including working with investigation teams in order to determine root cause, product impact, and appropriates corrective and preventive actions
· Vital to have extensive computer systems QA knowledge. (someone with only validation experience will not be suitable).
· Experience with review & approval of design specifications (User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS)) and test protocols (Installation Qualification (IQ), Operational Qualification (OQ)), plus experience developing validation strategies.
· Technical knowledge of how GxP related databases work- and OSI Pi strongly preferred.
- Greater than 5 years of industry experience in either validation, quality systems, operations, engineering or any combination thereof.
- Experience in two or more validation disciplines (Quality Management Systems, Laboratory Information Systems) with proficient technical knowledge
- Knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP) and review/approve lifecycle documentation (URS, FRS, FAT/SAT, Commissioning Protocols, etc).
- Working knowledge of GxP guidelines
- Experience with SAP, Documentum, Maximo, OSI Pi, Trackwise, SumTotal, LIMS, and/or SharePoint preferred.
Job Type: Contract
- computer system validation: 3 years (Preferred)
- QualityDocs, ComplianceWire, eTMF, Mastercontrol systems: 2 years (Preferred)