GMP Compliance Specialist (FullTime)

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Summary

• Help prepare Eyetech and contractor sites for Pre-Approval Inspection (PAI) including identifying and tracking required documentation using a PAI Documentation System database PAIDS
• Serve as Change Control Coordinator (ensures proper functioning of the change control process, assembles change committee, conducts follow-up.
• Handles Deviation and OOS (anomalous) investigations, follow up and tracking
• Helps administer General GMP and document specific training
• Performs API and Drug Product batch record reviews
• Assists Technical Writer in preparing GMP documents (SOPs, reports, etc.)
• Assists in the Corrective And Preventive Action (CAPA) development, design and implementation
• Assists in handling Supplier Quality Agreements (coordination, implementation and maintenance)
• Assist in conducting quality audits to ensure that Eyetech products are consistently manufactured according to CGMPs and US / overseas regulatory requirements.

Qualifications

• A minimum of 3-5 years experience in the pharmaceutical or allied industry is required, with experience in Quality Assurance, Quality Control, Validation or Regulatory Affairs.
• A B.S. degree in Chemistry (preferred) or other technical field such as biology or pharmacy.
• Strong working knowledge of cGMPs. Past experience with FDA or overseas regulatory authorities a plus.
• Demonstrated experience in the development, implementation and use of GMP-related quality systems
• Past experience in performing quality audits of pharmaceutical operations is a plus.
• Experience with active pharmaceutical ingredient operations is preferred.
• Ability to travel approximately 15%.
• Strong written and verbal communication skills. Must be able to deal effectively with employees at all levels.