Summary
Our client, a Fortune 500 Medical Device Company, has engaged GForce Life Sciences to provide a Visual Inspection consultant. We are currently seeking an experienced Visual Inspection Consultant to join our to address and resolve AQL (Acceptable Quality Level) failures.
Project Overview
The Visual Inspection SME will play a crucial role in ensuring the quality, compliance, and accuracy of the visual inspection processes in accordance with industry standards and regulatory requirements at the site level. They will be responsible for developing and implementing inspection standards, training personnel, and providing expertise in visual inspection methodologies.
Key Responsibilities:
- Conduct thorough visual inspections of drug products to identify defects and non-conformities.
- Analyze the root causes of AQL failures and provide actionable recommendations for corrective actions.
- To develop and implement visual inspection standards and procedures specific to medical devices and pharmaceutical products.
- Train and mentor quality assurance personnel on best practices for visual inspection.
- Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to ensure comprehensive resolution of quality issues.
- Document findings, recommendations, and corrective actions in detailed reports.
- Provide ongoing support and expertise to the quality assurance team throughout the duration of the contract.
- Provide technical guidance and training to personnel involved in visual inspection activities.
- Ensure compliance with regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, USP790/1790) and internal quality standards through audits and assessments.
- Support regulatory inspections and audits related to visual inspection processes.
Qualifications
- Bachelor's degree in a relevant field (e.g., Pharmaceutical Sciences, Engineering, Quality Assurance).
- Minimum of 10 years of experience in visual inspection within the pharmaceutical industry.
- In-depth knowledge of AQL standards and practices.
- Proven track record of identifying and resolving quality issues in drug products.
- Proven experience as a visual inspection SME within pharmaceutical industries.
- In-depth knowledge of regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, USP790/1790) and industry standards related to visual inspection.
- Proven ability to develop and implement visual inspection procedures in a regulated environment.
- Strong analytical, problem-solving, and communication skills.
Term & Start
Duration: 1 month with the opportunity to extend as needed
Start date ASAP
Onsite fully in Braintree, MA
Full time (40 hours/week)
