Primary Responsibilities

• Scope/plan projects to identify compliance issues requiring remediation
• Perform process risk assessments
• Produce compliance life cycle documents, including specifications, protocols, commissioning tests, SOPs, training materials
• Write cGMP documentation ensuring compliance with quality systems, operational processes, industry standards

Preferred Qualifications

• Master’s degree (or foreign equivalent) in Pharmaceutical Manufacturing or related
• Knowledge of cGMP documentation
• Experience writing change control test plans, validation protocols,
• Experience managing quality risk analysis

Primary Responsibilities

• Review specifications/acceptance criteria for systems, processes, methods, equipment, facilities
• Write test protocols
• Oversee change control process
• Write SOPs for quality assurance/operations
• Develop traceability matrices to link levels of specifications, tests, risk assessments to show compliance with design qualifications
• Travel to unanticipated client sites

Preferred Qualifications

• Bachelor’s degree (or foreign equivalent) in Biology, Chemistry, Pharmaceutical Sciences or related
• 1 year or more experience in risk assessment of facility, utility, systems/equipment qualification
• 1 year or more experience in method/process validation
• 1 year or more experience in aseptic process/computer system validation.