Website Asset Recruitment
job ref #00905
The Quality Specialist will act as the Computer Systems Quality representative in support of Computerised System Validation (CSV) activities executed on site. The role requires thorough understanding and experience of the validation requirements associated within a GMP manufacturing facility in order to provide quality oversight and guidance.
Essential Duties and Responsibilities
- The Quality Specialist will initially provide support for the start-up of the GMP manufacturing facility and long term will support ongoing CSV activities during sustaining operations
- Provide quality oversight and service in the areas related to Computer System Validation (CSV) and IT compliance with regulatory requirements
- Ensure that all systems, conform to relevant regulatory requirements, company specifications and standards as well as industry best practice.
- Work with the global IT QA team to establish and implement local computer system quality and compliance procedures
- Review and approve computerised system validation documentation and lifecycle documentation, including URS, FDS, Test Protocols/Reports, SOPs etc.
- Participate in software, equipment and instrument qualification where necessary.
- Participate in event/deviation investigation and change evaluation during qualification, to ensure the systems, software and equipment meet quality and compliance requirements prior to release.
- The Quality Specialist is responsible for ensuring that all manufacturing processes, QC and Enterprise systems perform and operate as per their design.
- Ensure the maintenance of the validated state of IT systems, equipment and instruments in routine operation.
- Follow SOPs to perform/support routine activities such as periodic reviews, Data Integrity audits, inventory log maintenance, etc.
- Qualification and management of Computer System suppliers and service providers.
- Actively encourage a culture of teamwork and integration with functional departments such as Automation & Information Systems (AIS), Engineering (ENG), and Process & Engineering Validation (PEV).
- Work with all personnel, contractors and visitors to ensure that all safety policies, procedures and
- regulations are fully adhered to across the site on an ongoing basis.
- Other tasks/responsibilities assigned by line manager.
Qualifications & Requirements:
- Ideally, experienced in establishing Computerised Systems and IT Infrastructure on a ‘greenfield’ context of similar size and scale.
- Demonstrated knowledge of GxP regulations (e.g. EU-GMP, FDA, ISO)
- Demonstrated knowledge of GAMP V guidelines
- Demonstrated passion for the computer system quality field
- Demonstrated experience in a Quality/Quality Assurance role within life science industry with a well-rounded exposure to all areas in this field
- Experience in areas related to computer system quality (CSQ, ITQ, software quality, CSV, etc.)
- Experience working in the Biologics manufacturing industry is preferred.
- Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is preferred.
- Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project
- Strong level of experience working in sustaining environment
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
- Previous experience working in a CMO is advantageous.
- Knowledgeable of FDA/EMA regulatory requirements and ICH and ISPE guidelines applicable to biologics and/or pharmaceuticals.
- Familiar with software development life cycle (SDLC).
- Familiar with quality requirements of all stages in SLDC.
- Bachelor’s degree in an Engineering or Scientific related discipline is the preferable qualification, other related and equivalent qualifications will be considered.
- Bachelor or above degree majored in IT or other fields with good understanding of IT.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to think critically and demonstrate troubleshooting and problem solving skills.
- Self-starter and self-motivated; organised with good attention to detail.
- Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
- Results oriented, with the ability to manage multiple priorities in a short period of time.
- <5% Domestic & international travel may be required on occasion to conduct supplier audits