Address
Form of work Responsibilities:
- Review internal and external validation protocols and technical report for validation/qualification of facility, equipment, and systems
- Perform validation document Gap Analysis for equipment with QC and Manufacturing Operations and support the implementation of remediation plans
- Lead implementation of validation program, review SOPs and make recommendation as needed
- Collaborate with cross-functional teams to ensure that validation approach meet regulatory and industry requirements
- Investigate and resolve validation-related issues
- Seek education and remain informed on current industry trends, regulations, and best practices
- Review and approve equipment calibration and maintenance documents
- Provide QA/QV support for continuous improvement projects, including data integrity initiatives within the laboratory and manufacturing environment.
- Work with Manufacturing Operations, Quality, in-house technical groups, and other site/networks as required to assist with establishing validation plans, validation strategy, specifications, and qualification protocols
- Perform Impact / Risk Assessments
- Provide QA/QV support in the implementation of change controls and commitment action items
- Participate in audit and inspection readiness activities
- Perform all other related duties as assigned
Requirements:
- Broad knowledge FDA and international regulations related to GMPs and Pharmaceuticals
- Knowledge on regulatory expectations and industry practices for validation using Product Lifecycle approach
- Effective written, oral, and interpersonal communication skills
- Technical writing skills to effectively develop procedures, discrepancies, change controls and associated documents needed to support the validation effort
- Experience organizing and managing responsibilities while working independently with minimal oversight
- Time and project management skills with the ability to multi-task and meet deadlines
- Strong time-management skills and the ability to organize and coordinate multiple projects at once
- Proficiency in enterprise systems, Microsoft Office and other office productivity tools with aptitude to learn new software and systems
- Bachelor's degree in a scientific discipline or another discipline with equivalent experience and training
- 5+ years of QA/QV experience developing and executing equipment qualification, process, cleaning, computerized systems validation projects in a Quality Assurance or Technical Services capacity
- Strong background and knowledge of EU & US Health authority requirements on equipment, systems, facilities qualification for both API and finished pharmaceutical products
- Knowledge of cGMPs and Global Regulatory (E.g., FDA / MHRA / EMEA) guidelines acquired through education, experience, and training
