ESSENTAIL FUNCTIONS AND RESPONSIBILITIES
• GMP compliance improvements.
• Perform GMP audits for all internal operations
• Oversee deviations, CAPA and product complaints.
• Provide cGMP compliance guidance to other departments.
• Writing new and revising current standard operating procedures (SOPs), specifications, etc.
• Reviewing all GMP documentation, including BPRs and monitoring data.
• Reviewing trending data.
• Provide support to customer and regulatory audits.
• Recommends and implement new policies and procedures to improve existing processes and products
• Writing and reviewing validation protocols, reports and master plans.
• Problem resolutions with GMP systems
• BS degree in Science discipline - Chemistry, Chemical Engineering, Biology or equivalent
• Minimum of 5 years’ experience in GMP compliance
• Experience in GMP manufacturing environment, Quality Assurance and Quality Control
• Experience with GMP document control, validation, qualification and calibration
• Ability to work in ISO7 and ISO8 control environment and support real time batch record review
• Extensive experience in internal auditing as well as working with regulatory agencies
• Ability to effectively organize, multitasks, and works in a fast-paced, deadline driven work environment.
• Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues.
• Excellent written and oral communications skills
• Ability to work independently and manage one’s time
• Communicate effectively and ability to function well in a team environment
• Basic computer knowledge, including Microsoft Word and Excel (used daily)
• Detail oriented with the ability to troubleshoot and resolve equipment problems