We are currently partnered with an exciting Biologics company in Ireland who are looking for a number CSQ consultants for an exciting upcoming project. The contract will be long-term and looking to start ASAP.
If you have IT Quality (ITQ), Compuer System Quality Assurance, IT Quality Assurance & IT Compliance experience please reach out for more details!
1. Be the owner of one or more elements of the global computer system quality system (CSQS), maintaining and working with CSQS owner to improve the element(s).
2. Act as computer system quality (CSQ) representative for assigned functional area(s), provide daily CSQ oversight and guidance, and ensure the implementation of the. Specific responsibilities include but are not limited to the following:
- Make contributions to the continuous improvement of CSQS by gathering and analyzing feedback from business areas, and sharing the feedback with CSQS owner and CSQ group?
- Work with site CSQ Team to establish and implement local computer system quality and compliance procedures;
- Establish effective communication with responsible functional area(s) and other global functional areas such as Automation & Information Systems (AIS), Engineering (ENG), and Process & Engineering Validation (PEV), and provide quality oversight and service in the areas related to computer system validation (CSV) and IT compliance with regulatory requirements, CSQS, and industry best practice;
- Apply risk-based approaches in daily quality work, and ensure computer systems in responsible areas are validated prior to go-live, and stay in continuous validated status throughout the life cycle of the systems?
- Conduct daily CSQ operation tasks: review/approve CSV documents, ensure CSV is conducted properly, approve computer system incidents, deviations, and CAPAs, coordinate computer system access roster review and periodic review, and so on and so forth.
3. Work with CSQ supplier management process owner to ensure computer system suppliers in responsible area are properly assessed/audited before being used, and managed throughout usage.
4?Assist internal and external audits and regulatory inspections.
- Bachelor or above degree majored in IT or other fields but with good understanding of IT
- 8+ years of work experience, at least 5 of which must be in life science industry and in areas related to CSQ (computer system quality, computer system quality assurance, IT quality, IT Quality Assurance, software quality, etc.)
- Familiar with software development life cycle (SDLC)
- Familiar with quality requirements of all stages in SLDC
- Good communication skills, particularly cross-function communication
- Good balance between having team spirit and working independently
- Familiar with questions and challenges in audits and regulatory inspections
- Demonstrated passion for computer system quality field
ADDITIONAL POSITION SPECIFIC DUTIES/INFO (Not Covered in Generic Description of Job):
- Certifications with regulatory agencies (FDA?EU?WHO, etc.) preferred
- Certifications with quality organizations preferred