Responsibilities

The GMP Documentation Review Specialist will :

• Review draft protocols and procedures for accuracy and completion against SOP’s, Specifications and requirements trace matrices.
• Perform Documentation QC Checks on draft protocols and reports.
• Manage the routing to approve and incorporation of comments.
• Support Commissioning, Qualification and Validation resources with managing discrepancies and GDP.
• Review executed protocols for completeness, focusing on Good Documentation Practices and assurance that data is attributable, legible, contemporaneous, original, and accurate.
• Work with Commissioning, Qualification and Validation resources to correct issues.
• Manage the review and approval of post executed protocols and test plans.
• Draft Standard Operating Procedures / Control Forms.
• Support QA management in the Quality Management System, including.

Qualifications :

• Bachelor's degree in a science-related field or relevant work history in a related position
• Prior GXP experience required, preferably cGMP.
• Ability to multi-task in a fast-paced environment
• Self-starter able to work independently.
• Excellent verbal and written communication and listening skills required.
• Experience and proficiency using Microsoft Office Products
• Basic math skills
• Outgoing attitude and desire to achieve results.
• Orientation towards teamwork and a collaborative work environment.
2 days ago