Senior Quality Assurance Specialist & Deputy Responsible Person (Deputy RP) – Geneva (Switzerland)
Valuing People. Science. Life - At Labatec Pharma, we are committed to deliver medicines that help to improve quality of life for patients around the world by meeting the needs of the hospital and retail sectors. We collaborate all together to deliver outcomes which add significant value to our clients’ projects and the community as a whole. Our people are at the center of Labatec Pharma.
Labatec is looking for talented individuals to join its growing team! Join us!
We are currently looking for a Senior Quality Assurance Specialist & Deputy Responsible Person (Deputy RP) to join our QA team.
Your key responsibilities:
- Act as Deputy Responsible Person (Deputy RP) in accordance with applicable Swissmedic requirements, the company establishment licence and defined internal delegation of responsibilities.
- Ensure that medicinal products distributed to the Swiss market comply with applicable regulatory and quality requirements.
- Ensure that distribution activities comply with Swissmedic establishment licence requirements for import, export, wholesale distribution and brokerage of medicinal products.
- Provide oversight of GDP activities including storage, distribution, transport controls and handling of medicinal products across the supply chain.
- Ensure traceability of medicinal products throughout the distribution chain, in accordance with GDP requirements.
- Qualify, approve and periodically monitor GDP/GMP subcontractors, including contract manufacturers, third-party logistics providers, warehouses, distributors and other GxP service providers.
- Maintain subcontractor qualification and monitoring documentation, including risk assessments, qualification questionnaires, licences and certificates, audit status, performance monitoring and periodic requalification.
- Review, negotiate and maintain Technical/Quality Agreements (TQAs) with external partners, including contract manufacturers, service providers, distributors and logistics providers.
- Manage deviations, investigations, complaints, quality incidents and corrective and preventive actions (CAPA), including follow-up and effectiveness checks.
- Perform QA assessment and approval of Change Controls, with particular focus on changes affecting outsourced activities, manufacturers, suppliers, logistics operations, product quality and the Swiss supply chain.
- Act as a qualified GxP auditor: plan, conduct and document internal and third-party/subcontractor audits and follow audit observations and CAPAs through closure.
- Monitor the quality performance of subcontractors through deviations, complaints, temperature excursions, audit findings, CAPAs, service KPIs and other relevant quality indicators.
- Support the RP during Swissmedic inspections and regulatory interactions and provide Deputy RP coverage as required.
- Support continuous improvement of the Quality Management System (QMS).
- Review and approve SOPs and quality documentation.
- Perform risk assessment and mitigation related to distribution and outsourced GxP activities.
- Participate in quality-relevant projects and other improvement projects aligned with the Quality Strategy.
- Report quality defects to Swissmedic according to applicable requirements and timelines, as delegated and in coordination with the RP.
- Handle quality defects with the responsible supplier and/or manufacturing site.
- Remain up to date with Swiss regulatory requirements, authority organisation, processes and the regulatory environment, and communicate applicable requirements to relevant internal and external stakeholders.
- Prepare and perform the QA review of product release dossiers for medicinal products intended for the Swiss market, ensuring that required manufacturing, testing, supply-chain and quality documentation is complete before submission to the RP for release.
We are looking for
- University degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences or another relevant scientific discipline; a Pharmacy degree is preferred where appropriate to the scope of the Swiss establishment licence.
- Qualification and professional experience appropriate to act as Deputy Responsible Person under applicable Swissmedic requirements; evidence of qualifications is required.
- Proven experience as Deputy RP and/or RP in Switzerland is strongly preferred.
- Significant experience in pharmaceutical Quality Assurance within a GMP/GDP-regulated environment.
- Demonstrated experience in qualification, approval and ongoing monitoring of GDP/GMP subcontractors, including logistics providers, distributors and contract manufacturers.
- Qualified and experienced GxP auditor, with demonstrated experience conducting third-party/subcontractor audits and following audit CAPAs through closure.
- Strong practical experience with deviations, investigations, CAPAs and Change Control, including QA impact and risk assessment.
- Experience reviewing, negotiating and maintaining Technical/Quality Agreements (TQAs) with external GxP partners.
- Experience compiling and reviewing product documentation/dossiers supporting RP release of medicinal products for the Swiss market.
- Experience interacting with regulatory authorities and supporting or hosting regulatory inspections, preferably including Swissmedic.
- Strong knowledge of Swissmedic GDP/GMP requirements, EU GDP/GMP Guidelines, PIC/S requirements and pharmaceutical Quality Systems.
- Previous experience working at a pharmaceutical manufacturing site is preferred, particularly in Quality Assurance, Quality Control or Production.
- Fluent in French and English (verbal and written); German fluency or strong professional proficiency is preferred.
- Able to work effectively in cross-country and cross-functional teams and to operate autonomously when required.
- Rigorous and methodical, with an analytical mindset and strong problem-solving skills.
- Demonstrated trustworthiness and professional integrity.
- Knowledge of solid, semi-solid, liquid and sterile dosage forms, including injectable-product manufacturing processes; experience with aseptic manufacture is preferred.
About us
Labatec is a Swiss-based private pharmaceutical company, headquartered in Geneva, Switzerland. Our company has 60+ years experience in the production and supply of medicines to 11 countries comprising Switzerland, the Middle East and North Africa and expanding today in Europe. We aim to be a leading licensing partner in generic and specialty innovative medicines in our markets with an extensive portfolio of 70+ products in both the retail and hospital segments. We serve our communities by developing, manufacturing, and distributing high quality medicines covering major therapeutic areas such as musculo-skeletal, ophthalmology, anaesthetics, oncology, anti-infectives and women’s health.
For more information, please visit our website:
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