Specialist/Senior Specialist GMP QA - CMC Operations

About the role

Join our client as a Specialist/Senior Specialist in Quality Assurance to support GMP manufacturing activities. You will provide expertise and guidance on GMP compliance, ensuring adherence to regulatory standards, and work collaboratively with cross-functional teams to maintain high-quality standards in manufacturing operations.

Responsibilities

• Develop and implement quality oversight strategies for contract manufacturing organizations (CMOs).
• Support regulatory inspections and internal audits.
• Review Master Production Batch Records, Executed Batch Records, analytical results, and supporting data packages.
• Complete batch record review checklists as applicable.
• Review and approve analytical methods, product specifications, method validation protocols, and reports.
• Oversee stability protocols, data tables, and stability reports.
• Manage and review deviations, out-of-specification (OOS) and out-of-trend (OOT) investigations.
• Oversee corrective action/preventive action (CAPA) activities and change control processes.
• Review and approve process validation protocols and reports.
• Investigate and manage product complaints and assist with recall or stock recovery investigations.
• Conduct QA GMP vendor audits and prepare audit reports.
• Stay updated on FDA, EU, and ICH regulations and advise on their impact on GMP activities.
• Collaborate with cross-functional project teams to ensure compliance and quality standards.
• Travel up to 25%, including international travel, as required.

Requirements

• Bachelor's degree in a scientific or related discipline; advanced degrees are a plus.
• Experience in the biotech or pharmaceutical industry with a focus on Quality Assurance.
• Familiarity with EU, FDA, and ICH regulations and guidance documents.
• Strong organizational, prioritization, and time management skills.
• Proficient in computer applications and productivity software.
• Excellent oral and written communication skills.
• Ability to work effectively in cross-functional teams.
• ASQ certification is a plus.
• Self-motivated with a strong focus on quality and attention to detail.

Pay

$140,000 to $160,000 per annum.