Job Description

Quality specialist.

Main task:
Handling of deviations and CAPAs
Complaint handling
Product Quality review (author)
SOP handling (follow up TBR, updating of SOPs, coordination of SOP, review etc. Compliance Wire reseponsible person
Support projects.
Participate in problem solving and be a professional support for the plant and departement.
Batch documentation (support to QP, follow up against department)

Department QA DABR

Main tasks:
Handling of deviations and CAPAs
Complaint handling
Product Quality review (author)
SOP handling (follow up TBR, updating of SOPs, coordination of SOP, review etc.
Compliance Wire reseponsible person
Support projects.
Participate in problem solving and be a professional support for the plant and departement.
Batch documentation (support to QP, follow up against department)

Qualifications:

• Batchlor or master’s degree in pharmacy or equivalent
• Experian’s from pharmaceutical industry
• Experience from GMP work.
• Know your way around Office programs.
• SAP, Veeva, Trackwise, Digital , LIMs.
• Solution oriented – the favorable candidate is one who identifies a problem, identifies and propose solutions, finds the relevant facts before asking for presenting and asking for assistance.
• Structured – enjoys setting goals, timelines and achieving them promptly.
• Positive – An attitude that invites collaboration and makes the process of achieving difficult/complex tasks, enjoyable.
• Social – ability to interact with others regardless of ethnicity, religion, gender, political views, or personal world view.
• Enjoys working with experts from other fields including Quality Control analysis, Manufacturing, Packaging, Research & Development, Regulatory affairs, Artwork Management, Suppliers and Authorities around the world.
• A teachable spirit – the ideal candidate identifies the complex nature of drug manufacturing and its implications to human life. Moreover, being sober and clear about the things one does not understand and the willingness to critically ascertain the information one perceives as the truth is a critical part of being suitable for this job.

Team members including leader – 18.
Gender distribution – 17 female and 1 male
Age distribution – 29 – 67 years
Average education – master’s degree in pharmacy
Experience in GE – 1-30 years
Common behavioral attributes– Analytical, Social, Integrity, High work capacity, Service oriented, High delivery.

Work environment in the department is generally at a high pace.
QP release of products to the market. I addition a range of activities from drug development, upscaled production, technical transfers, to manufacturing and product discontinuation. The Correct candidate to this position will work together with the QPs

The candidate will work with routine activities that are very important to serve the market with products. candidates which have succeeded in the past have been solution oriented, hardworking, show a high level and analytical aptitude, enjoy upbeat work environments and cross-functional cooperation with other departments, sites (Cork & Shanghai) and world (Suppliers and customers all over the world)

It is a temporary position (Maternity leave) but might be a permanent position. It is not possible to say at the present time It depends on the qualification and the business need.

Additional Information