Specialist, Compliance in Pharma Operations

Be a part of Applied Pharmaceutical Innovation as a Specialist, Compliance dedicated to GMP compliance. This full-time, on-site position plays a crucial role within pharmaceutical manufacturing operations, ensuring adherence to stringent standards.

In this role, you will work collaboratively to maintain and document compliance processes for sterile injectable manufacturing. Your attention to detail will assist in deviation management, equipment documentation, and adherence to change control processes, ensuring inspection readiness and quality assurance.

Key Responsibilities:

• Prepare and review GMP production and equipment documentation

• Oversee production record compliance and accuracy

• Manage deviations and track investigative processes

• Coordinate change controls affecting production

• Conduct routine compliance audits across production

Requirements:

• Bachelor’s degree in Chemistry, Pharmacy, or life science

• 3-5 years in cGMP regulated manufacturing

• Strong skills in technical writing and documentation

• Proficient in Excel and Word for manufacturing-related tasks

• Experience in hands-on pharmaceutical activities preferred

Enhance compliance and support manufacturing integrity at API.