Deputy QP, Biologics

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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