Summary
An excellent opportunity for an experienced API QA Analyst to join an large pharmaceutical organisation on a contract basis. The role focuses on API release procedures and manufacturer audits which will be on an international basis. To be considered for this role you must have QA experience gained in an API environment preferably pilot plant/laboratory scale.
The Company
The company is a Global Pharmaceutical organisation with a rich pipeline in R&D as well a wide portfolio of licensed products. The organisation manufactures API material both in-house and through out sourcing internationally.
The Role
This role is based in a pilot plant and laboratory environment and will involve all aspects quality assurance through to batch release. This will include batch record review/documentation; deviation investigation and approval; review and approval of validation and qualification protocols plus auditing on an international basis including Europe and India. The role also entails broader site wide QA support ensuring ongoing GMP and GDP compliance.
The role is offered on an initial 6 month basis with strong chances of extensions. The successful candidate must be prepared to travel internationally.
Experience
The successful applicants MUST have QA experience from a GMP-compliant Pharmaceutical environment relating to API production. Ideally this will be include pilot plant and laboratory scale facilities. Expertise should include all aspects of batch release including deviations resolution and documentation plus site auditing.
Keywords:
Quality Assurance, QA, GMP, cGMP, GDP Batch Documentation, SOP Review, Continuous Improvement, Process Improvement, Investigation, Deviation, Customer Complaint, CAPA, Quality Officer, QA Associate, QA Scientist, QA Officer, CIP, Site Quality Management System, Active Pharmaceutical Ingredient, API, Pilot Plant
This is a contract position