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Deputy QP, Biologics
- Permanent
- Good Manufacturing Practice (GMP)
- Netherlands
Proclinical are recruiting for a Deputy QP, Biologics to join a pharmaceutical organisation. This role is on a permanent basis and is located in Hoofddorp.
Responsibilities:
- Handle QA batch release planning of products weekly.
- Assist with technology transfers and process/analytical method validation actions from quality operations perspective when needed.
- Evaluate, prepare batch document for QP batch certification of clinical trial batches, as well as guarantee proper upkeep of product specification files to guarantee compliance with INDs and IMPDs.
- Prepare yearly product evaluations of biologics products.
- Collaborate with the quality systems manager to assist with the QA IT systems and serve as a back-up for QA IT systems actions.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a degree level in a (bio-)chemistry, pharmacy or similar field.
- At least 5 years of experience in a pharmaceutical drug substance and/or drug product manufacturing field.
- Expertise on EU GMP, US CFRs.
- Computer literacy.
- Fluency in the English language.
- A tenure of at least 5 years.
- Familiarity working within a pharmaceutical, sterile manufacturing setting.
- Knowledge in manufacturing, regulatory, QA/QC, QA operation, etc.
- Acquaintance in preparing batch release, which involves batch documentation evaluation and preparing for batch certification.
- Prior involvement and expertise on cGMP, QC/QC and regulatory compliance such as US, EU and any other global agencies.
- Comprehension of API/DP pharmaceutical operations, QA/QC procedures and contract manufacturing.
- Comprehension of multifaceted change control procedures and engagement with regulatory affair procedures.
- Comprehension of regulatory proposal processes.
- Able to evaluate and examine and analyse technical documents and offer quality assessments on change controls, deviations and complaints.
- Acquaintance working with electronic document management, electronic training systems and Trackwise.
- Comprehension of risk assessment and risk management fundamentals/tools.
- Former involvement engaging with external parties.
- Experience interacting with external parties.
If you are having difficulty in applying or if you have any questions, please contact Ayesha Kippie at +41 615 687 995.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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#QACompliance
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