Overview

QA Compliance is committed to actively support the Couvet site fully aligned with WuXi STA requirements, the cGMP and applicable laws, regulations, and standards. This position is within the Quality System and Compliance organization, reporting to the Senior Manager, Quality System & Compliance.

The position supports the maintenance and improvement of the assigned processes and activities: Inspection Management, Internal audit Program, Supplier Management, Quality Management Review, Quality agreements, Deployment & execution of annual GMP training and regulatory affairs activities support.

The 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.

The position will be working closely with the Quality System & Compliance manager to identify and handle process quality and cGMP compliance related issues on a risk-based approach as well as to ensure lean processes in his/her scope of activities.

Qualifications

Experience / Education

BSc/BA or MSc in Science or relevant discipline.
At least 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.
Experience in supplier Management is a plus.
Auditor skills is a plus.

Knowledge / Skills / Abilities:

Very good understanding of cGMPs and EU, Swiss, and FDA 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.
Very good written & oral communication skills in both French and English. Ability to communicate effectively to management, functional groups, broader organization, and executives.
Ability to focus attention.
Good investigational and problem solving skills.
Knowledge on Veeva and TrackWise (is a plus) and of IT-principles.
Good customer/client focus to build/maintain relationships with key stakeholders

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Responsibilities

Writes, revises, reviews and approves quality documents for the Quality compliance.
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 and coordinates timely responses.
Maintains/improves all elements of processes in the frame of their responsibility, including local procedures, forms, training materials…. where applicable;
Updates elements of the processes in the frame of their responsibility, to comply with regulatory requirements, Health authority expectations and with STA global procedures where applicable as a risk-based approach and to reflect practices;
Acts as Subject Matter Expert in the frame of their responsibility.
Supports internal GMP-audit process:
- Yearly internal audits plan definition and execution;
- Ensures internal audits, and consequent actions plans, are performed accordingly;
- Executes self-inspections;
- Performs GMP area evaluation.
Supports the local supplier management system including the electronic system in place:
- Ensures GMP material and vendor related activities for qualification
- Yearly supplier audits plan definition, execution and follow-up
- Performs supplier audits;
- Periodic evaluation definition and execution;
- Participates to / assess e-system updates initiatives or quality document update as local SME (Subject Matter Expert) as well as at a global level (including trouble shooting, qualification activities…).
Contributes of regular reporting of quality processes metrics for quality management review meetings (including meeting hosting).
Supports creation and revision of Quality agreements.
Supports the deployment and execution of GMP training intended for Couvet manufacturing site departments involving GMP activities.
Supports regulatory affairs activities.
Ensures the representation of QA Compliance within department and cross-functional project teams according to assignments.
Acts as deputy for colleagues within QS & Compliance team.Acts as deputy for colleagues within QS & Compliance team.

STA Pharmaceutical

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