Raleigh Metro Area, NC
- Requires Bachelors or Masters in Scientific or Engineering Discipline with 5+ years of pharmaceutical experience in Validation and Quality. Detailed knowledge of cGMPs. Detailed knowledge and experience of computer systems validation. Part 11 experience and knowledge. 1 year contract
Experience with Trackwise, SAP, LIMS/Labware. required
Proven ability to work in a team environment through conflict resolution and negotiations. Excellent written and verbal communication skills.
- Review and approve site process validation, packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time and quality to ensure that programs are compliant with inspection agencies requirements and related SOPs.
- Ensures implementation of validation and transfer requirements by providing direction and support for quality / cGMP matters.
- Ensures that the site has a comprehensive Validation Master Plan and that it is properly maintained and followed.
- Follow up of identified validation deviations and escalation to QA management.
- Interface with Quality Assurance and IT partners to ensure validation practices are aligned with regulatory expectations and best practices.
- Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables. Coordinate documentation, testing, and change management activities to ensure compliance with business and regulatory needs
- Computer Systems - Interprets complex technical quality requirements in specific situations, such as validation of new systems, upgrades, changes or remediation, to set validation/compliance strategy.
- Reviews results of audits and periodic reviews and determines appropriate corrective actions. Oversees the application of corrective actions and may lead the work of lower-level resources and/or contractors, providing leadership and technical training.
- Responsible for performing technical quality review and approval for GxP computer and Part 11 related documentation and interfaces with internal partners to analyze data and situations leading to sound decision-making.