QC Computer Systems Validation (CSV) Lead is required for the QC department of a new purification and aseptic manufacturing plant at Grifols Worldwide Operations (GWWO).
Reporting directly to the Quality Control (QC) Manager of Grifols Worldwide Operations (GWWO).
* Responsible for the Computer System Validation (CSV) process for the QC department as CSV SME
* Develop, implement and improve procedures and processes for the complete QC computer systems validated state lifecycle
* Ensure all QC computer systems are in compliance with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, also requirements from EU Annex 11 and all Data Integrity standards and guidelines
* Plan and manage the cGMP validation test and documentation phase of the implementation with risk analysis used to define critical components to be validated
* Implement GxP Risk Management process and ensure that appropriate mitigation steps are implemented to meet current GxP regulations
* Develop templates as required for Validation documentation
* Manage, prepare and execute all related CSV documentation including validation master plans and protocols. Prepare reports of executed protocols for review.
* Prioritize qualification activities in line with the project schedules and business needs
* Responsible for software application change control process and mechanisms to maintain a state of continued compliance for the system
* Manage deviations, CAPA's and change control's related to the QC computer systems
* Support projects and continuous improvement initiatives
* Participate in international project teams relating to QC and wider quality activities where travel maybe required
* Prepare for, and support regulatory and internal inspections/audits
* Provide hands-on guidance and training when needed to QC personnel
* Provide end user support to QC personnel for the relevant computer systems
* Ensures area of responsibility is maintained in a state of compliance and audit readiness
* Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training
* Provide QC departmental support in other activities as requested
* Strong Computer Systems Validation understanding
* Strong knowledge of all relevant regulations and a thorough understanding of the various computer system validation guides such as ISPE GAMP etc.
* Excellent understanding of data integrity compliance requirements
* Good problem solving and continuous improvement skills
* Ability to work accurately under pressure
* Ability to handle multiple projects and deadlines
* Good communication skills and the ability to collaborate at a variety of levels within and outside the organisation
* Ability to work on own initiative
* Proven success working well in a team environment with flexibility to react to changing business needs, as well as project management ability
* Prior CSV experience with analytical instrumentation qualification and computer systems implementation
* Interpret and apply applicable CSV regulatory guidelines
* Understanding of laboratory processes and testing.
* Knowledge of microbiology and chemistry compendial test methods
* Experience in HPRA/FDA
* In-depth knowledge of data integrity requirements
* Experience in software application change control process and mechanisms
* Excellent verbal and written communication. Must be able to read, write, and speak English.
* Must have strong technical writing skills.
* Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
* Strong organizational, analytical and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.
* Bachelor's degree in technical discipline (e.g. biochemistry, chemistry, engineering) or equivalent
* Requires a minimum of 5 years of related experience