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Senior Computer Systems Validation Specialist
2 months ago
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Career Developers Inc, a reputable staffing agency and consulting firm, is proud to have served the industry for three decades.
With a history of excellence and a commitment to providing comprehensive staffing solutions for both commercial and government sectors, we maintain a strong presence nationwide.
Our carefully curated client partnerships allow us to deliver exceptional service that stands out in the industry.We are dedicated to managing your expectations effectively through insightful business practices, thorough interview preparation, transparent communication, and constructive feedback throughout your journey.
We are excited to assist you in advancing your career.Position Overview:
Senior Computer Systems Validation (CSV) Specialist - (Senior Manager Level)
Location:
Must reside locally or be willing to relocate independently.
Compensation:
Competitive salary plus bonus opportunities.
POSITION SUMMARY
The Senior CSV Manager is tasked with the planning, drafting, execution, and evaluation of validation protocols for GxP computerized systems. This role involves assessing, recommending, and implementing technological solutions that enhance digitization, compliance, and operational efficiency.
Acting as the CSV subject matter expert, you will provide guidance on GxP regulations, electronic records/signatures, and data integrity standards.
You will collaborate with colleagues across the organization to uphold quality, data integrity, and CSV protocols.ORGANIZATIONAL STRUCTURE
The Senior CSV Manager reports directly to the VP of IT and does not have any direct reports.
KEY RESPONSIBILITIES
- Develop validation plans, installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ), and final validation reports.
- Review and endorse other CSV-related documentation, including User Requirements (URS), Functional Specifications (FS), and Design Specifications (DS).
- Lead efforts to resolve data integrity or critical quality issues related to IT Quality Management.
- Engage in the continuous enhancement of IT quality management systems and computer systems validation.
- Manage external vendors when necessary to fulfill validation tasks.
- Support project teams in the review and QA approval of system validation in accordance with FDA guidelines.
- Provide expertise and guidance on 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements, as well as data integrity principles.
LEADERSHIP RESPONSIBILITIES:
- Establish and maintain policies and procedures regarding SAP management, ensuring compliance and providing necessary information for audits.
- Guide the SAP Security Administrator in developing security management procedures.
- Serve as the site lead for significant NPI projects involving production, plant maintenance, and quality management.
- Foster collaborative relationships with contractors and consultants for large system implementations.
- Oversee QUMAS SAP documentation structures and usage.
SAP MAINTENANCE & GxP:
- Generate system documentation for configurations or developments related to GxP processes.
- Review SAP audit trails.
- Contribute to the Global Validation team by providing system validation documentation, including validation plans, protocols, reports, and risk assessments.
- Ensure continuity in validation documentation for original implementations and new site rollouts.
QUALIFICATIONS
- A minimum of 8 years of experience in the validation of computerized systems, with a strong preference for expertise in ERP and laboratory systems.
- At least 6 years of experience working within quality systems in a GMP pharmaceutical manufacturing environment.
- Key attributes include attention to detail, thoroughness, and a strong desire to learn.
- Excellent communication skills.
- Experience in the manufacturing industry with a solid understanding of business processes and information flow.
- Strong foundational knowledge of ERP systems.
- Ability to assist users in resolving system-related issues.
- Proficient in reading and interpreting technical manuals for new organizational units.
- Capable of maintaining records, writing reports, and creating presentations.
- Exceptional organizational skills.
- Self-motivated and a collaborative team player.
- Minimal travel required.
DECISION-MAKING AUTHORITY:
- Authorized to approve GMP documentation related to computerized systems or their components.
