Deputy QP, Biologics job in Hoofddorp, Netherlands

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

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Phone Number*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP)

Location: Netherlands

This vacancy has now expired. Please see similar roles below...

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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