We are recruiting, on a consulting mandate, an experienced collaborator in Quality Compliance for pharmaceutical products. You will be based at our client's manufacturing site and be in charge of the following tasks:
Executes self-inspections and following-up on action plans.
Supports the supplier qualification process by assisting in material supplier and vendor evaluation and approval. Provides support for vendor and supplier contract setup and modification, as needed. Is responsible to handle deviations, CAPA and change controls related to suppliers.
Generates Annual Product Review reports.
Supports the product quality complaints process by handling complaints, executing investigations as assigned.
Assists with writing SOPs and makes recommendations for SOP revisions for the Quality Operations
At least 5 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance.
BS in Science or related field.
Very good understanding of cGMPs and regulatory requirements.
Good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred.
Excellent interpersonal, collaborative and organizational skills.
Works independently on routine tasks, makes decisions for minor issues.
Ability to focus attention to details.
Very good written & oral communication skills.
Very good investigational and QA problem solving skills.
Knowledge of most common office software (Microsoft Office).