SENIOR QA SPECIALIST – VALIDATION
Irvine, California, United States
Job Description
RESPONSIBILITIES:
QUALIFICATIONS:
- Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
- Authors/approves and executes qualification protocols and reports.
- Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
- Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
- Qualification of Vendors Selected.
- Input to the development of the URS/FRS/DDS.
- Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
- May present qualification studies to Regulatory and Client Auditors as required.
- Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
- Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
- Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
- Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
- Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
- Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
- Other responsibilities and special projects will be assigned based on business and customer needs.
QUALIFICATIONS:
- Bachelor's degree in sciences or engineering
- 5+yearsexperiencein a highly regulated pharmaceuticals industry or related field
- Demonstrated experience with qualification commercial processing a packaging equipment.
- Proven track record of managing projects from start to finish on time and on budget.
- Strong working knowledge of cGMP and regulatory standards for validation.
- Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
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