דרושים Quality Assurance Associate/ Deputy Rp Year Contract ב-טבע ב-Denmark

As Quality Assurance (QA) Associate / Deputy Responsible Person you will conduct QA tasks in accordance with applicable regulations and guidelines on Good Distribution Practice (GDP) and distribution of medical devices and by applying Teva Policies, Standards and Procedures.

We are looking for a replacement for a maternity leave, you will receive a 1 year contract ideally starting on Dec 1st 2025.

Local Quality System deployment :

• Support maintenance of the Quality Management System (QMS) for Teva Denmark.
• Help ensure compliance with Teva Corporate Policies, Standards and Procedures as well as European and local SOPs.
• Help ensure compliance with current Good Distribution Practice (cGDP) for distribution of medicinal products and requirements related to distribution of medical devices.

Operational implementation Quality Management System (QMS):

• Training
• Support distribution of SOPs for training.
• Support other training activities as required.
• Market release of medicinal products and medical devices
• Ensure market release from approved suppliers based on applicable batch release documentation and transport conditions documentation – support 3rd party logistics service provider as needed.
• Product Quality Complaints
• Ensure that product quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions.
• Ensure that replies are shared with complainants as applicable.
• Liaise with pharmacovigilance department if necessary e.g. through monthly reconciliation.
• Euphoriant substances
• Handle activities related to euphoriant substances such as management of import and export certificates.
• Help ensure compliance with current regulations as regards euphoriant substances.
• Falsified Medicines
• Help ensure prompt and correct handling of suspected falsified medicine in accordance with local legislation and Teva procedures.
• Support the assessment of FMD alarms.
• Self-inspections
• Participate in self-inspection according to a pre-defined program and help ensure that necessary corrective actions are implemented.
• Suppliers, customers and subcontractors
• Help ensure that customers and suppliers are in the possession of the appropriate authorization and certificates.
• Support maintenance of a list of approved suppliers / customers / subcontractors.
• In the absence of the RP,
• Ensure that critical quality issues are timely managed in accordance with procedures in place.
• Ensure coordination and promptly performance of any recall operations.
• Provide the local monthly quality metrics to the European Commercial Quality.

Authorities inspection readiness:

• Help ensure inspection readiness.
• Participate at GDP and medical device inspections performed by the Danish Medicines Agency and Internal Audits.

• Pharmacist or other relevant theoretical education in natural sciences on a master level, or bachelor level.
• Experience from work within QA and/or in a Danish pharmaceutical subsidiary and/or head quarter function.
• Knowledge of Good Distribution Practice (GDP) and basic knowledge of Good Manufacturing Practice (GMP).
• Demonstrate initiative and creates an appropriate level of urgency to meet objectives and deadlines.
• Able to learn independently and quickly.
• Oral and written fluency in Danish and in English

• Vacation leave according to The Danish Holiday Act
• 5 extra holiday entitlements plus one extra free day in December
• Competitive salary
• Bonus based on personal and company result
• Collective health insurance
• Flexible working conditions with hybrid working policy
• Competitive Pension
• A very diverse International team

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

In this role, you will be responsible for working with the LSO to manage and maintain the Pharmacovigilance function in Denmark and Norway and ensure regulatory compliance, in conjunction with Teva Global and European PV and local Teva management.

Pharmacovigilance Operations & Compliance

• Support the establishment and maintenance of a compliant Pharmacovigilance (PV) function for Teva Denmark and Norway
• Ensure compliance with local and global PV regulations in collaboration with the Local Safety Officer (LSO)
• Keep all local and global PV tracking systems regularly updated
• Accurately record and document all audit-relevant processes and procedures, ensuring data privacy and confidentiality

Stakeholder Collaboration

• Liaise with Teva’s Global and European PV departments, including the European Qualified Person for Pharmacovigilance (EU QPPV)
• Work closely with local Teva management and cross-functional teams as needed

Cluster & Regional Support

• Act as Deputy/Back-up LSO for Denmark and Norway
• Collaborate with and provide support to LSOs in the Nordic Cluster, including serving as back-up during their absence

Meetings & Projects

• Participate in Global and European PV meetings
• Contribute to European PV projects and working groups organized by Global Patient Safety and PV leadership

• You have a degree in life Sciences, pharmacist, or health science professional degree
• Minimum 3+) years’ experience in pharmacovigilance, and preferable with experience as a Deputy LSO or similar role
• Knowledge and understanding of relevant PV regulations for medicinal products
• You will have strong stakeholder management skills with demonstrable experience of working successfully under pressure and in a rapidly changing environment
• You thrive in having multiple tasks with deadlines, while still paying attention to quality and details
• You will be able to work independently but be a team player and collaborate/support your colleagues when needed
• You will be a strong communicator with fluency in both English and Danish, and a good understanding of Norwegian is a must

• Vacation leave according to The Danish Holiday Act
• 5 extra holiday entitlements
• Competitive salary and pension
• Bonus based on personal and company result
• Collective health insurance
• Flexible working conditions with hybrid working policy
• Competitive Pension
• Opportunity to work in a very diverse and supportive international team

LSO Denmark and Norway

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Senior Manager Commercial Quality/RP is a position located in our commercial affiliate in Denmark. The position is reporting directly to the Site General Manager and has a Quality reporting line to the Associate Director Commercial Quality FI and North & West Europe Hub

• Manage and lead the Commercial Quality Team in Denmark.
• Act as Responsible Person in accordance with EU Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) and applicable regulations on medical devices / food supplements.
• Establish network in the country with direct reports and relevant stakeholders
• Lead periodic Local Quality Management meetings with commercial unit Management and other supportive functions (Supply chain, Regulatory Affairs, Pharmacovigilance…)
• Have regular meetings with the local General Manager of the commercial unit and Associate Director Commercial Quality N&W Hub to align quality objectives with business objectives and local strategic plans
• Participate in the annual budget elaboration
• Lead periodic face to face meeting with CQ team members and lead periodic local CQ meetings
• Support Teva and Quality strategic business initiatives
• Support Quality initiatives outside the country and collaborate with international colleagues as needed
• Ensure GDP compliance at the commercial unit and promote quality culture
• Build relationship and act as contact person for local authorities
• Lead inspection readiness programs
• Lead Local cross functional Quality Management Review or delegate appropriately
• Attend to N&W Hub and European monthly Quality Councils
• Provide the local monthly quality metrics to the European Commercial Quality
• Provide GxP guidance and quality oversight of local GxP business activities/deliverables
• Define a delegate as back up and keep appropriate records of any delegated duties

You are an enthusiastic professional with a Master in Pharmacy or an equivalent combination of education and experience to the functional role. On top of this you will bring a few years of experience as a Quality Manager, QP or RP in a pharmaceutical company or importer/distributor.

• Demonstrated knowledge and working experience with government regulations and local authorities in Denmark
• In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance
• Working knowledge of pharmaceutical operations
• In-depth understanding of GxP regulations
• Experience with development and implementation of Quality Systems and application of risk assessment tools
• Proficient computer skills in current software including MS Office
• Demonstrates initiative and creates an appropriate level of urgency to meet objectives and deadlines.
• Proven ability to work within a team and influence people outside areas of authority to achieve results.
• Demonstrates good communication (oral and written) skills.
• Excellent proficiency in English and Danish

• Vacation leave according to The Danish Holiday Act
• 5 extra holiday entitlements
• Competitive salary
• Bonus based on personal and company result
• Collective health insurance
• Flexible working conditions with hybrid working policy
• Competitive Pension
• A very diverse International team

Ivo Huijskens - Senior Recruiter Europe

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.