Quality Assurance Manager
Vor 2 Tagen
As a key member of our Quality Assurance team, you will play a critical role in ensuring the quality and integrity of our medicinal products. In this role, you will act as the Deputy Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) for Biogen Switzerland AG, responsible for ensuring compliance with all national and international regulations, including the Swiss Medicinal Products Licensing Ordinance (MPLO) and the Swissmedic Technical Interpretation I-SMI.TI.17.
Key Responsibilities- Ensure Quality Assurance related compliance with all National and International Regulations (e.g. MPLO, Cantonal Laws and Regulations etc.) and internal regulations.
- Manage, report and document product returns including decision on re-integration to saleable stock.
- Decide independently from Biogen Management and Swiss Affiliate Leadership Team on disposition of rejected, recalled, falsified and expired products.
- Manage Product Quality Review (PQR/AQP) Assessments as per applicable SOPs and local law.
- Ensure Inspection readiness of the applicable Operational License activities, e.g. import and wholesales activities.
- Ensure timely renewal and update, if applicable, of Operational Licenses per Swissmedic License Application Process (min 6 month before expiry of license).
- Knowledgeable on GMP/GDP and changing Regulatory requirements and ensure appropriateness of licenses and distribution models to distribute medicinal products.
- Ensure that suppliers and customers are approved in coordination with responsible departments.
- Approve any sub-contracted activities, which may have an impact on GMP/GDP regulations, and is responsible for qualification and monitoring of such activities.
- Develop and maintain local Quality Agreements.
- Ensure that any additional requirements imposed on certain products by local Regulatory Bodies are adhered to.
- Develop and maintain local procedures in alignment with the local regulations and Global QMS.
- Manage locally initiated and continuous training program including GxP training.
- Oversee and approve local quality records (deviations, CAPAs and Change Controls) and supports as needed other quality related tasks (Audit Module, Technical Product Complaints, Planned Exceptions).
- Host local Health Authority inspections and Internal Affiliate Audits including readiness and follow up before, during and after the inspection/audits.
- Coordinates related follow ups and CAPA development and implementation.
- Lead, develop and coordinate local Self-Inspection program as per schedule, including risk assessment, and leads related follow ups and CAPA development and implementation.
- Review and evaluate internal audit reports, including CAPAs, of Manufacturer, CMOs, CROs and Service Providers involved in the manufacturing, distribution and storage of medicinal products intended for the Swiss market.
- Request additional CAPAs if deemed necessary to comply to GMP/GDP Regulations and local registration requirements.
- Ensure Technical Product Complaints (TPCs) are handled as per local and Global procedures and support TPC-related investigations and follow-ups, as necessary.
- Ensure that customer complaints are addressed appropriately and dealt effectively.
- Execute recalls in collaboration with local and global Recall Committees upon approval by Swissmedic.
- Act as local coordinator of a recall to be performed on the Swiss territory, including Lichtenstein.
- Compile the local recall report upon closure of the recall by Swissmedic.
- Follow-up on additional request by Swissmedic after closure of the recall (e.g. CAPA implementation).
- Ensure that suspected falsified products are immediately notified for investigation and coordinate local management of the issue.
- Manage temperature excursion assessments and finally decide on usability of affected products.
- Cooperate with all necessary departments to ensure that communication to Health Authorities is appropriate, coordinated and approved.
We are looking for a highly skilled and experienced Quality Assurance professional to join our team. The ideal candidate will have a strong background in pharmaceutical or related industry, with a minimum of 5 years' experience in QA/RA. Fluency in English and German is required, and a Master's degree in pharmaceutical or natural sciences is preferred.
What We OfferAs a member of our Quality Assurance team, you will have the opportunity to work with a global team of talented and passionate individuals who are committed to delivering life-changing medicines. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
How to ApplyIf you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].
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