Job Description
At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Senior Consultant, Quality Compliance & Data Integrity.
Position Type:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Komal at 862-390-7418 to learn more.
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Senior Consultant, Quality Compliance & Data Integrity.
Position Type:
- Contract
- On-Site
- 10+ years of pharmaceutical/GMP experience, preferably in sterile manufacturing.
- Strong expertise in Data Integrity and Quality Compliance.
- Proven experience with retrospective data reviews and FDA remediation.
- Strong understanding of ALCOA+, 21 CFR Part 11, GMP documentation, deviations, investigations, and CAPA.
- Previous experience supporting an FDA inspection, Form 483 response, or remediation program is highly desirable.
- Experience reviewing equipment and process qualification documentation, including IQ/OQ/PQ and associated validation records, deviations, change controls, and requalification activities.
- Demonstrate strong analytical skills, attention to detail, regulatory judgment, and the ability to work independently within a demanding remediation environment.
- Conduct comprehensive retrospective review of GMP documentation and historical data.
- Review and assess qualification and validation documentation for manufacturing equipment, systems, utilities, processes, and associated validation/qualification records. Including URS, IQ, OQ, PQ, commissioning documentation, protocols, reports, deviations, and associated change controls, to determine whether equipment and processes were appropriately qualified and remain in a validated state.
- Assess records and data against ALCOA+, FDA cGMP, and Data Integrity requirements.
- Identify potential data integrity, GMP, and compliance gaps and assess their potential impact on product quality and sterility assurance.
- Review relevant batch records, deviations, CAPAs, environmental monitoring, microbiology, validation/qualification, and computerized system records.
- Support investigations, root cause analysis, impact assessments, and remediation activities related to the FDA 483 observations.
- Clearly document findings, rationale, and recommendations in an inspection-ready format.
- Evaluate process equipment and manufacturing systems used in sterile product manufacturing, including equipment qualification records, operating parameters, alarms, controls, maintenance/calibration records, and associated procedures, and assess their potential impact on product quality, data integrity, and sterility assurance.
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Komal at 862-390-7418 to learn more.
Numbers & Facts
| Location | Greenville, NC |
| Industry | Staffing/Employment Agencies |
| Salary | $50 Per Hour |
| Company Size | 100 to 499 employees |
| Website | http://www.hiredbymatrix.com |
About Company
We believe in putting people together for the right reasons. Getting you a great job that makes you feel fulfilled in your career. Finding the perfect candidate to help you achieve business success.
Whether you are looking for the best candidate for your company or searching for your next career move, we are dedicated to making sure you thrive. We take your needs personally and have a variety of services to ensure you reach your goals. We listen to the needs of our clients and candidates and then thoughtfully match the right person with the right job. When people come together doing what they love success is guaranteed and partnerships last.
Skills
- Analysis Skillsunmatched
- Biotech and Pharmaceuticalunmatched
- Calibrationunmatched
- Change Controlunmatched
- Code of Federal Regulationsunmatched
- Commissioningunmatched
- Consultingunmatched
- Corporate Complianceunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Data Analysisunmatched
- Data Qualityunmatched
- Detail Orientedunmatched
- Documentationunmatched
- Environmental Microbiologyunmatched
- Environmental Monitoringunmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- Manufacturingunmatched
- Manufacturing Equipmentunmatched
- Manufacturing Systemsunmatched
- Process Manufacturingunmatched
- Process Validationunmatched
- Quality Assuranceunmatched
- Record Keepingunmatched
- Regulationsunmatched
- Root Cause Analysisunmatched
- Validation Documentationunmatched
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