QA Specialist DK

Confidential

Denmark - Copenhagen

Apply now PharmaRelations is now recruiting a QA Specialist for a global biopharma company in Copenhagen
The position is temporary (12 months) and is based in Ørestaden, Denmark.

You will be part of a QA team of 4 persons in Denmark.

Main tasks:

• Product Complaint Management
• Batch Disposition and Release Management, support local QP
• Support Benelux: Batch administrative GDP release - Full process of reviewing 3PL inbound documentation, transport temperature data, decide on GDP release to saleable stock
• Deviation Management, when Deviation originates in the processes covered by Quality Specialist, or when separately agreed
• Document and Record Management (Veeva Vault)
• CAPA Management, as requested
• Change Control Management, supporting local change control processes
• Distribution and Vendor Management; Operational contact to 3PL for different distribution related questions including decision taking in case of temperature excursions. Quality agreement maintenance. Supplier verification activities, as requested
• Internal and External Audit Management, supporting local audits and inspections and related CAPA work, as requested
• Recall Management, supporting local recalls and mock-recall
• Narcotics management, local administrative activities

Competencies

• Has the ability to effectively interact with and influence internal personnel on product and quality related matters with a customer-oriented mindset
• Has a detailed, accurate way of working
• Ability to manage complex administrative tasks and manage own work
• Has ability to analyze data and information to draw conclusions and make effective decisions and escalate as required
• Self-motivated team player, who can support new ideas
• Possess root cause and risk management/assessment skills as needed
• Fluent and confident use of Danish and English language verbally and in reading & writing

Experience in working on QMS in the pharmaceutical industry would be an advantage

Next step
Please send your application as soon as possible. Use link below.

For further information contact:

Jens Knud Maarup, +45 5433 4320 or [email protected]