Vacature Senior QC Officer

About Pharming
Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

The role:

The Senior QC Officer plays a pivotal role in ensuring that our methods meet the highest standards of quality performance, comply with Good Manufacturing Practice (GMP) regulations, adhere to Standard Operating Procedures (SOPs), and are completed within agreed timelines at our contract laboratories.

Responsibilities include designing and overseeing validation and transfer studies, as well as managing the actual transfer of analytical methods. This involves ensuring that all test methods align with GMP regulations, maintain the required quality standards, follow SOP procedures, and are completed within the agreed timelines at contract laboratories.

Areas of responsibilities:

• Advice as subject matter expert for all test methods of one or more Pharming intermediates, drug substances and/or drug products
• To ensure that the methods are executed according to the required quality performance, GMP regulations, SOP procedures, within the agreed timelines at the contract laboratories.
• Transfer and validate all analytical methods of a Pharming intermediates, drug substances and/or drug products in commercial phase.
• Review and control outcome of all analytical methods during release and stability testing.
• Investigate and troubleshoot when deviations occur with test methods and report the investigation.
• Communicate with CLOs to ensure timely, reliable test results.
• Represent MCS in projects for advice and contribution on test method development, specifications, and stability studies.

Knowledge

• HLO / MSc or equivalent in analytical chemistry
• Expertise in analytical and assay techniques
• Good knowledge of English, both in word and writing
  

Experience:

• Minimum of 3 years experience in working in a pharmaceutical QC and/or R&D laboratory
• Minimum of 3 years experience in design of validation and transfer of analytical / biochemical / biological test methods to a GMP QC laboratory
• Minimum of 3 years experience in GMP

What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:

• A highly competitive salary
• 8.33% holiday allowance (for NL)
• A minimum of 30 vacation days
• An excellent pension plan
• Commuting allowance

You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs.

Functie:	qc officer
Startdatum:	10-03-2024
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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