Job Summary:

QA Compliance is responsible to define and maintain the Couvet’s Quality Management Systems (QMS) fully aligned with the Company QMS, the cGMP and applicable laws, regulations, and standards.

The position holder is responsible to define, maintain and improve local QMS, for the assigned processes and activities within QA Compliance team: Inspection Management, Internal audit Program, Supplier Management, Management Review.

Additional tasks are the monitoring of regulatory changes, response to regulatory authority’s requests, reporting of quality processes metrics, deployment, and execution of annual GMP training.

QA Compliance Sr. Specialist can be assigned special tasks in cross-functional projects to support Couvet manufacturing site activities like introduction of new product on the manufacturing site.

Essential Job Functions:

• Define annual internal audit plan and ensures internal audits, and consequent action plans, are performed accordingly.
• Execute self-inspections.
• Supports the supplier management project (qualification, monitoring, quality agreement) and perform supplier audits.
• Supports preparation and execution of health authority’s inspections, corporate and client audits in different roles (i.e., back office, subject matter expert, note taker or runner) for Couvet Site.
• Assess regulatory changes within expertise area.
• Coordinate data collection and support response related to regulatory authority’s requests, e.g., in the scope of submission or periodic GMP review. Collaborate with cross-functional departments to provide the information.
• Contribute of regular reporting of quality processes metrics for different review meetings
• Supports the deployment and execution of GMP training intended for Couvet manufacturing site departments involving GMP activities.
• Ensures the representation of QA Compliance within department and cross-functional project teams according to assignments.
• Write, revise SOPs and makes recommendations for SOP revisions for the Quality Compliance.
• Acts as deputy for colleagues within QS & QA Compliance team.
• Can be assigned “ownership” of QA Compliance processes, including coordination of day-to-day activity, maintenance of associated documentation, participation of process enhancement and training of new users.

Experience / Education

• BS in Science or related field.
• At least 5 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance.
• Experience in Supplier Management is a plus. 

Knowledge / Skills / Abilities:

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.
• Fluent in English (C1 level in written & oral)
• Knowledge of most common office software (Microsoft Office).
• Knowledge on TrackWise is a plus.