MF01-022624 Quality Control / Assurance Document Reviewer

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Quality Control / Assurance document review and approval

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 7 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Solid experience with QC Lab Analytical Equipment functionalities
• Experience with the Qualification of QC Lab equipment.
• Experience reviewing and revising documents related with qualification exercises.
• Experience with Computer System Validation Lifecycle documents such as URS, VP, RA, DQ, TMX, IOPQ, and so forth.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities:

• Review and revise documents related with qualification exercises.
• Act a Plant QC resource and support all qualification activities.
• Interpret and implement quality assurance standards and procedures.
• Evaluate adequacy of quality assurance standards.
• Document internal audits and other quality assurance activities.
• Investigate customer complaints and non-conformance issues.
• Review Risk Management documents.
• Assure ongoing compliance with quality and industry regulatory requirements.