QC CSV Lead
Company: Grifols Inc.
Posted on: June 11, 2021
Do you want to join an international team working to improve the
future of healthcare? Do you want to improve the lives of millions
of people? Grifols is a global healthcare company which, since its
foundation in Barcelona in 1909, has been working to improve the
health and well-being of people all over the world. Our four
divisions - Bioscience, Diagnostic, Hospital and Bio Supplies -
develop, produce and market innovative medicines, solutions and
services in more than 100 countries and regions.
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
- 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
- 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
- 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
- Provide hands-on guidance and training when needed to QC
- Provide end user support to QC personnel for the relevant
- 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
- Provide QC departmental support in other activities as
- 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
- 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
- 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
- Experience in HPRA/FDA
- In-depth knowledge of data integrity requirements
- Experience in software application change control process and
- 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
Location: EMEA : Ireland : Dublin:Grange Castle (Dublin)
Keywords: Grifols Inc., Birmingham , QC CSV Lead, Other , Birmingham, Alabama
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