Qualified Person (all genders) - Fulltime, permanent

Copy of Qualified Person (all genders) - Fulltime, permanent

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

Job Description : As Qualified Person (QP) (all genders) - fulltime, permanent for drug products manufactured or tested in Ludwigshafen (batch certification for bulk and finished drug products) you ensure that all required quality standards are maintained.

You are responsible for assessment and batch certification of bulk and finished drug products as Qualified Person (Annex 16 EU directive and 16 AMWHV, according to German Law) which are manufactured in Ludwigshafen.

Responsibilities :

• Ensuring compliance of APIs, excipients and packaging materials used for production of drug products manufactured in Ludwigshafen in all aspects of compliance.
• Act as Qualified Person for drug products manufactured or tested in Ludwigshafen (batch certification for bulk and finished drug products).
• Perform Batch certification for bulk and finished drug products.
• Review of documents, e.g. Investigation Protocols, Deviations protocols, Complaint reports and other GMP relevant reports. Provide directions and support on investigations, complaint reports and other quality improvement topics.
• Review Product Specification, Test Protocols, Batch Records, and if necessary, initiation of revisions.
• Assessment of general GMP documents and QTAs.
• Represent AbbVie Quality Assurance with external sites or customers.
• Training and education of pharmacist trainees (according to German Drug Law)

Qualifications :

• Examination as Pharmacist
• Qualification as Qualified Person according to German Drug Law and EU directive
• Excellent understanding of cGMP and QP obligations, drug product manufacturing, finished drug product packaging and market release
• Good German and English language skills
• Strong interpersonal and communication skills in a team
• Excellent communication and team interaction skills

We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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