QA CMO Junior Associate

Proclinical are recruiting for a QA CMO Junior Associate for a pharmaceutical organisation. This role is on a permanent basis and is located in Amsterdam.

Responsibilities:

• You will prepare yearly product evaluations of pharma branded products.
• Assist/handle the product specification rendering to present marketing authorisations and guarantee timely updated of suitable affiliated documentation in assistance for batch release.
• Serve as a QA stability coordinator for assuring consistent examinations of trends and preparation of stability reports, evaluate stability data and trending.
• Participate in the comprehension of regulatory needs in new or current pharma branded department pertinent SOPs.
• Any other assigned duties.

Key Skills and Requirements:

• Educated to a degree level in a (bio-)chemistry, pharmacy, biotechnology or similar field.
• At least 3 years of experience working in a pertinent pharmaceutical drug substance and/or drug product manufacturing.
• Know-how of EU GMP.
• Computer literacy.
• Fluency in the English language.
• At least 3 years of tenure.
• Familiarity working within a pharmaceutical, sterile manufacturing setting.
• Knowledge of manufacturing, QA/QC, QA manufacturing operation.
• Acquaintance with preparing batch release, which involves batch documentation evaluation and batch certification.
• Past involvement and expertise on cGMP, QA/QC and regulatory compliance such as US, EU and any other global agencies.
• Expertise and familiarity with API/DP operations, QA/PQC procedures and contract manufacturing.
• Comprehension of multifaceted change control procedures and engaging with regulatory affairs procedures.
• Comprehension of regulatory proposal procedures.
• Able to evaluate and examine manufacturing and analytical technical documents and offer quality examinations on change controls, aberrations and complaints.
• Familiarity with document management, electronic training systems and trackwise.
• Presentation, interpersonal and communication skills both verbally and in writing.
• Abilities in deliberating and influencing others.
• Capable of handling various, multifaceted prioritises simultaneously and shifting priorities.
• Ability to effectively manage multiple, complex tasks and quick shifting of those.
• Works well in a team.

If you are having difficulty in applying or if you have any questions, please contact Ieuan Phillips at +44 203 846 0643.

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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