Quality Assurance Associate/ Deputy RP (1 year contract)
Søborg, Denmark, 2860
Who we are
The opportunity
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.
How you’ll spend your day
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.
Your experience and qualifications
- 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
Enjoy a more rewarding choice
- 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
Already Working @TEVA?
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