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Are you a seasoned professional with a passion for ensuring the highest standards in pharmaceutical manufacturing? This role as a Senior Consultant, Quality Compliance & Data Integrity in Greenville, NC, offers you the chance to make a significant impact by supporting a leading pharmaceutical client. Your expertise will be crucial in conducting retrospective Data Integrity reviews for sterile products’ manufacturing, ensuring compliance with stringent industry standards.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Consultant, Quality Compliance & Data Integrity will be varied; however, the key duties and responsibilities are as follows:
1. Conduct comprehensive retrospective reviews of GMP documentation and historical data.
2. Review and assess qualification and validation documentation for manufacturing equipment, systems, utilities, processes, and associated records.
3. Assess records and data against ALCOA+, FDA cGMP, and Data Integrity requirements.
4. Identify potential data integrity, GMP, and compliance gaps and assess their impact on product quality and sterility assurance.
SKILLS AND EXPERIENCE:
To be successful in your application to this exciting role as the Senior Consultant, Quality Compliance & Data Integrity, the following skills and experience are essential:
1. Extensive pharmaceutical/GMP experience, preferably in sterile manufacturing.
2. Strong expertise in Data Integrity and Quality Compliance.
3. Proven experience with retrospective data reviews and FDA remediation.
4. Strong understanding of ALCOA+, 21 CFR Part 11, GMP documentation, deviations, investigations, and CAPA.
This role is ideal for someone with a keen eye for detail and a strong background in pharmaceutical compliance. You will play a pivotal role in supporting investigations, root cause analysis, and remediation activities related to FDA 483 observations, ensuring that all findings and recommendations are documented in an inspection-ready format.
If you are ready to take on this challenging and rewarding role, apply now to join a dynamic team dedicated to maintaining the highest standards in pharmaceutical manufacturing. Your expertise will help ensure product quality and sterility assurance, making a real difference in the industry.
Key Words: Senior Consultant / Quality Compliance / Data Integrity / Pharmaceutical / GMP / Sterile Manufacturing / FDA Remediation / ALCOA+ / 21 CFR Part 11 / Validation / CAPA
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Are you a seasoned professional with a passion for ensuring the highest standards in pharmaceutical manufacturing? This role as a Senior Consultant, Quality Compliance & Data Integrity in Greenville, NC, offers you the chance to make a significant impact by supporting a leading pharmaceutical client. Your expertise will be crucial in conducting retrospective Data Integrity reviews for sterile products’ manufacturing, ensuring compliance with stringent industry standards.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Consultant, Quality Compliance & Data Integrity will be varied; however, the key duties and responsibilities are as follows:
1. Conduct comprehensive retrospective reviews of GMP documentation and historical data.
2. Review and assess qualification and validation documentation for manufacturing equipment, systems, utilities, processes, and associated records.
3. Assess records and data against ALCOA+, FDA cGMP, and Data Integrity requirements.
4. Identify potential data integrity, GMP, and compliance gaps and assess their impact on product quality and sterility assurance.
SKILLS AND EXPERIENCE:
To be successful in your application to this exciting role as the Senior Consultant, Quality Compliance & Data Integrity, the following skills and experience are essential:
1. Extensive pharmaceutical/GMP experience, preferably in sterile manufacturing.
2. Strong expertise in Data Integrity and Quality Compliance.
3. Proven experience with retrospective data reviews and FDA remediation.
4. Strong understanding of ALCOA+, 21 CFR Part 11, GMP documentation, deviations, investigations, and CAPA.
This role is ideal for someone with a keen eye for detail and a strong background in pharmaceutical compliance. You will play a pivotal role in supporting investigations, root cause analysis, and remediation activities related to FDA 483 observations, ensuring that all findings and recommendations are documented in an inspection-ready format.
If you are ready to take on this challenging and rewarding role, apply now to join a dynamic team dedicated to maintaining the highest standards in pharmaceutical manufacturing. Your expertise will help ensure product quality and sterility assurance, making a real difference in the industry.
Key Words: Senior Consultant / Quality Compliance / Data Integrity / Pharmaceutical / GMP / Sterile Manufacturing / FDA Remediation / ALCOA+ / 21 CFR Part 11 / Validation / CAPA
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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