Overview
On Site
Full Time
Skills
Computerized System Validation
Regulatory Compliance
Process Engineering
Test Scripts
Writing
Testing
GxP
Management
Editing
IQ
OQ
PQ
ISO 9000
Documentation
GDP
Pharmaceutics
Risk Management
Risk Analysis
GAMP
Veeva
Startups
Software Development Methodology
Job Details
Responsibilities:
Requirements:
- Designing and executing validation including support of computer system validation protocols to ensure consistency of data production and compliance with client's quality standards (including internal ISPE referenced guidelines, client procedures, and 21 Code of Federal Regulations Part 2XX and 8XX level standards which apply to the equipment and product being validated).
- Ensuring product and process development activities have all necessary validation and supporting justification.
- Developing technical documents utilizing a simple non-technical general description. This requires understanding of highly technical automated equipment.
- Running test scripts and making recommendations for design or process modification based on test results.
- Owning validation process (or portion thereof) not only from an engineering standpoint but also from a client and team relationship standpoint.
- Developing and writing technical change controls from a general non-technical description of the change to a product, process, equipment, protocol, packaging, outcome, or location of equipment.
- Documenting the planning and design required to support the changes, approvals, and testing.
- Managing the overall documentation development and approval process including explanation and justification of document testing, content, and strategy from a quality and regulatory standpoint to facilitate acceptance and approval of the document by required signatories.
Requirements:
- Bachelor's degree or higher required.
- 7+ years of validation experience in the pharmaceutical GxP regulated environment required.
- Direct experience authoring/editing/executing validation documents including plans, requirements, IQ, OQ, PQ and change controls.
- Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including.
- Good Documentation Practice (GDP) in pharmaceutical environment.
- ICH 8, 9, 10 - Knowledge of Risk management and Risk Analysis Tools.
- GAMP5.
- Flexible schedule that allows for work activities during times that align with different time zones.
- Experience implementing/validating the following Veeva Clinical systems: Study Startup and Site Connect capabilities.
- Strong understanding of SDLC deliverables.
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