Quality Assurance Specialist, delegated QP

Found in: beBee jobs DK - 2 weeks ago


Copenhagen, Copenhagen, Denmark Nomeco AS Full time

Join Specific Pharma and contribute to easier access of unlicensed medicine for patients with special needs.

We are a North European market leader within unlicensed medicine.

We provide unlicensed medicines and medicines for special purposes, such as clinical trials and situations of drug shortages. We provide tomorrow's medicine today.

Quality Assurance

Specific Pharma invites you to be a part our organization, where your expertise will have a significant impact on our efforts to ensure timely release of unlicensed medicine.

To excel in this position, it is imperative that you are comfortable with your knowledge of relevant rules, regulations and guidelines. This will enable you to act as a decision-maker in releases of the products. Although you will work with many day-to-day tasks, your role will also mean working strategically, setting the standard for the Quality Management System (QMS).

Your workplace will be in Copenhagen (Sydhavnen), where you will report directly to the Head of QA.

Key Responsibilities

Ensure compliance with Good Manufacturing Practice (GMP) in the release of the products Ensure compliance with Good Distribution Practice (GDP) in the distribution of the products Work across departments to continuously improve the product release process Participate in handling of deviations, Corrective and Preventive Actions (CAPAs) and Change Controls Handling of recalls and complaints Writing and maintaining SOPs Involve in internal and external inspections, including audits from Authorities and our customers Contribute to the development and maintenance of QMS, D4 Qualifications and experience 3 to 5 years of relevant experience in the pharmaceutical industry, preferably within QA Strong written and verbal skills in Danish and English Personal Attributes Proactive in improving QMS Comfortable balancing quality demands, risk and business needs Strong communication skills and motivation to drive new initiatives Contact If you have any questions, please contact Head of QA, QP & RP - Asja Devedzic Riis or via e-mail, We are looking forward receiving your application.
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