QA Manager Pharmaceuticals
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands.
- Ensures CAPAs are initiated and resolved.
- Batch record review.
- Intake of product complaints for EU and/or related investigations.
- Liaise with QP and other quality groups to develop, implement and maintain global quality systems as well as site-specific quality systems (GMP) in the EU.
- Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
- Minimum of 3 years’ QA experience in a pharmaceutical
- Minimum of 3 years of management/leadership experience
- Working knowledge of GMPs in conformance to EU standards
- Ability to train, manage, and develop teams
- Excellent verbal and written communication skills
- Professional working knowledge of English and preferably Dutch
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Turlough White.
The Company
With a wide range of generic medicines on the market such as cardiovascular, dermatological, antibiotics, antihistamines, antidepressants and a range of inhalations products. This company has all disciplines in-house for product development. With a dedicated professional team, the highest standards are pursued in the areas of Registration, Quality, Pharmacological and Supply Chain.Role Description
In this role you are responsible for the QA department, including the operational QA tasks. Oversee manufacturing processes and manufacturing personnel regarding Quality. You will train, lead, and coach teams whilst developing and implement Quality floor processes. Receipt and disposition of incoming materials. Review batch-related documentation, and ensures resolution of issues to release product. Oversee the packaging and shipping process for the EU.Responsibilities
- Ensure Deviations are initiated, investigated and resolved.- Ensures CAPAs are initiated and resolved.
- Batch record review.
- Intake of product complaints for EU and/or related investigations.
- Liaise with QP and other quality groups to develop, implement and maintain global quality systems as well as site-specific quality systems (GMP) in the EU.
- Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
Requirements
- Bachelor’s degree or Master's in the life sciences or related field.- Minimum of 3 years’ QA experience in a pharmaceutical
- Minimum of 3 years of management/leadership experience
- Working knowledge of GMPs in conformance to EU standards
- Ability to train, manage, and develop teams
- Excellent verbal and written communication skills
- Professional working knowledge of English and preferably Dutch
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Turlough White.
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