Senior QA Specialist, CSV

Job Description

The Senior QA Specialist – Computer Systems Validation is responsible for providing Quality oversight of our Company’s Engineering, Quality Control, IT and Validation groups to ensure compliance with applicable regulations, guidance’s, industry standards and Company policies/procedures supporting the commercial GMP manufacturing of biological drug substance and drug product. The position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the Engineering, Quality Control, IT and Validation organizations. This role will help support the quality review of validation project plans, user requirements, test strategies, electronic record and signature assessments and summary reports to address Validation lifecycle (including developing GxP computer system validation and CFR 21Part 11 related documentation).

The Role
o Serve as the QA-CSV liaison with the Engineering, Quality Control, IT and Validation organizations to support company goals, client projects, continuous improvement initiatives and as a general resource.
o Ensure site systems are compliant with the corporate Data Integrity program.
o Review and approve equipment/software qualification protocols such as IQ/OQ/PQ. Examples of equipment includes bioreactors, SCADA, PI historian, Environmental Monitoring Systems, chromatography systems, controlled temperature units, filling/stoppering machines, autoclaves and critical utilities.
o Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance’s on electronic data integrity.
o Provide QA support to enforce CSV guidelines, policies and procedures for control systems, automation, analytical equipment and IT applications
o Collaborate with manufacturing, engineering, validation, QC and IT to provide training and coaching on CSV projects and data integrity initiatives
o Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements
o Identify data integrity risks and propose improvement plans
o Serve as QA resource supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities.
o Provide QA support for deviations related to Engineering, Facilities, Automation, IT, Quality Control and Validation groups. Perform Root Cause Analysis (RCA) and investigations to evaluate product impact and assist in identifying Corrective and Preventive Actions (CAPA).
o Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
o Serve as the QA-CSV resource for expansion projects which includes construction of cleanrooms, commissioning, and qualification of utilities such as HVACs, Process Gases, Water for Injection (WFI), automation systems and fill lines
o Review and approve Standard Operating Procedures (SOPs)
o Participate in site and corporate quality and process improvement initiatives.
o Support client and regulatory audits.

The Candidate
o Bachelor’s degree in a Science or Engineering field with 6 years of experience or Master’s degree with 3 years of experience.
o In depth knowledge of FDA guidelines and Global cGMPs relavant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines
o Experience performing/supporting computer systems validations associated to IQ, OQ & PQ for software systems (SCADA, PI Historian, BMS, EMS, TrackWise, etc.)
o Able to work in a team setting and independently under minimum supervision.