Offre d'emploi - Quality Assurance Officer – Quality System & Compliance
(On-site)
offer published 1 day(s) ago
Quality Assurance Officer – Quality System & Compliance | Permanent position – On-site
Are you a detail-oriented and proactive professional with a strong interest in quality system and regulatory compliance within the pharmaceutical industry? Join Leman SKL Pharmaceuticals to reinforce our team as QA Officer and contribute to the robustness, performance, and continuous improvement of our Quality Management System (QMS).
About Us
Leman SKL Pharmaceuticals is a private and independent Swiss pharmaceutical company based in Geneva. With subsidiaries across Europe, Mexico, and Hong Kong, we are expanding globally while staying true to our core values: quality, agility, and a deep commitment to patient and healthcare professional needs. We offer an entrepreneurial and collaborative environment where you can grow your career and contribute to meaningful healthcare solutions.
Your Role
As a Quality Assurance Officer – Quality System & Compliance, reporting to the Quality Assurance Manager/Deputy QP, you will play a central role in the implementation, maintenance and continuous improvements of the company’s Quality Management System (QMS). You will act as a key point of contact for quality systems internally and externally, ensuring that processes are compliant, efficient, and aligned with applicable GxPs requirements. You will also support the compliance of the QMS in the global markets ; and act as Quality expert on the serialization across the organization. You contribute to strengthening the quality culture across the organization and its international subsidiaries.
This role is ideal for a quality professional who thrives in a dynamic environment and is eager to further develop their expertise in pharmaceutical quality assurance. You will gain valuable hands‑on experience while working in a fast‑paced, collaborative setting that supports both professional growth and continuous improvement.
Key Responsibilities
QMS
* Manage the implementation, maintenance, and continuous improvement of the QMS across headquarters and subsidiaries.
* Write, review, and update SOPs, work instructions, and quality documents in compliance with GxPs, and internal standards.
* Ensure proper document control, versioning, and archiving in line with regulatory expectations
* Promote harmonization and standardization of quality processes across the organization.
* Act complementarily within the Quality Team for managing Quality Operations for Quality Product and Third‑party qualification maintenance.
Audits, Inspections & Compliance
* Plan, perform, and report internal audits, ensuring proper documentation of observations.
* Manage corresponding CAPAs: follow‑up on implementation, assess effectiveness, and ensure timely closure.
* Lead inspection and audit readiness activities received by the entities of the Group, coordinate preparation for regulatory inspections, received audits and maintaining internal audit/inspection documentation.
* Support regulatory authority inspections and partner audits.
Training & Quality Culture
* Coordinate and maintain the QMS training program.
* Develop and update training materials related to quality processes and regulatory requirements.
* Maintain the training matrix and ensure training compliance across departments.
* Train new comers and perform refreshers when required.
Performance & Change Management
* Manage the Change Control process from initiation to closure, ensuring proper impact assessment and documentation.
* Define, track, and analyze Quality KPIs to monitor QMS performance.
* Identify trends, risks, and improvement opportunities based on quality metrics.
* Contribute to Management Review.
Cross‑functional Collaboration
* Work closely with internal teams, including Regulatory Affairs, Pharmacovigilance and other departments to ensure that quality systems meet compliance requirements.
* Provide QA support to business projects and operational activities.
* Participate in continuous improvement initiatives and process optimization.
* Coordinate and support serialization activities across internal functions and external partners, ensuring alignment with quality and regulatory requirements across all markets and affiliates.
* Act as quality expert internally for transversal requirements or projects, such as serialization, industrial operations, market opening and product launches.
Your Profile
* Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or a related field.
* 4‑6 years of experience in Quality Assurance within the pharmaceutical industry, with a strong focus on QMS and compliance.
* Good knowledge of EU GxPs, and other relevant regulatory requirements.
* Strong organizational skills with the ability to manage multiple priorities.
* Excellent communication and interpersonal skills in a cross‑functional environment.
* Fluent in English and French.
What We Offer
* Impactful role – Play a key role in maintaining the quality of pharmaceutical products and ensuring compliance with global standards.
* Dynamic environment
* Collaborative culture – Join a supportive and pragmatic team working together to achieve high standards of quality.
* Work‑Life Balance – Enjoy 30 days of annual leave and the flexibility to work partially from home.
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