QP - IMP (Investigational Medicinal Products)

Adecco

Posted on Jan 30, 2025 by Adecco
Not Specified, Netherlands
Research
Immediate Start
Annual Salary
Full-Time

Qualified Person - IMP (Investigational Medicinal Products)

Are you a driven and detail-oriented professional looking to make a significant impact in the pharmaceutical industry? Our client, a leading organisation in the field, is seeking a Qualified Person (QP) for Investigational Medicinal Products (IMPs) to join their dynamic team in the Netherlands. If you have a passion for quality assurance and regulatory compliance, this is the perfect opportunity for you!

Key Responsibilities:

As the QP for IMPs, you will play a crucial role in ensuring that investigational products meet the highest quality and safety standards.

Your key responsibilities will include:

  • IMPs Release and Certification: Certify the release of IMPs for clinical trials, ensuring adherence to EU GMP Annexe 13 requirements and product specifications.
  • Quality Oversight: Provide quality oversight for manufacturing, testing, and distribution activities, ensuring compliance with GMP and Good Clinical Practise (GCP).
  • Documentation Review: Review and approve batch manufacturing records, validation protocols, and analytical data to verify compliance with GMP requirements.
  • Regulatory Compliance: Stay updated on evolving EU and international GMP regulations, providing guidance and support to project teams.
  • Training and Development: Mentor Quality Assurance staff and cross-functional team members on GMP requirements for IMPs.

Qualifications:

We're looking for candidates who possess the following qualifications and experience:

  • Education: Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, or a related field.
  • QP Certification: Must be a certified Qualified Person (QP) recognised under EU Directive 2001/20/EC with experience in IMP certification.
  • Experience: A minimum of 5 years in Quality Assurance or a similar role within the pharmaceutical industry, with a focus on IMPs.
  • Technical Skills: Strong problem-solving and analytical skills, excellent written and verbal communication in English, and the ability to manage multiple priorities in a fast-paced environment.

Preferred Skills:

  • Experience with regulatory inspections (eg, EMA, MHRA).
  • Familiarity with quality management systems (QMS) and electronic documentation systems.


Reference: 2888751973

https://jobs.careeraddict.com/post/99139824

This Job Vacancy has Expired!

Adecco

QP - IMP (Investigational Medicinal Products)

Adecco

Posted on Jan 30, 2025 by Adecco

Not Specified, Netherlands
Research
Immediate Start
Annual Salary
Full-Time

Qualified Person - IMP (Investigational Medicinal Products)

Are you a driven and detail-oriented professional looking to make a significant impact in the pharmaceutical industry? Our client, a leading organisation in the field, is seeking a Qualified Person (QP) for Investigational Medicinal Products (IMPs) to join their dynamic team in the Netherlands. If you have a passion for quality assurance and regulatory compliance, this is the perfect opportunity for you!

Key Responsibilities:

As the QP for IMPs, you will play a crucial role in ensuring that investigational products meet the highest quality and safety standards.

Your key responsibilities will include:

  • IMPs Release and Certification: Certify the release of IMPs for clinical trials, ensuring adherence to EU GMP Annexe 13 requirements and product specifications.
  • Quality Oversight: Provide quality oversight for manufacturing, testing, and distribution activities, ensuring compliance with GMP and Good Clinical Practise (GCP).
  • Documentation Review: Review and approve batch manufacturing records, validation protocols, and analytical data to verify compliance with GMP requirements.
  • Regulatory Compliance: Stay updated on evolving EU and international GMP regulations, providing guidance and support to project teams.
  • Training and Development: Mentor Quality Assurance staff and cross-functional team members on GMP requirements for IMPs.

Qualifications:

We're looking for candidates who possess the following qualifications and experience:

  • Education: Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, or a related field.
  • QP Certification: Must be a certified Qualified Person (QP) recognised under EU Directive 2001/20/EC with experience in IMP certification.
  • Experience: A minimum of 5 years in Quality Assurance or a similar role within the pharmaceutical industry, with a focus on IMPs.
  • Technical Skills: Strong problem-solving and analytical skills, excellent written and verbal communication in English, and the ability to manage multiple priorities in a fast-paced environment.

Preferred Skills:

  • Experience with regulatory inspections (eg, EMA, MHRA).
  • Familiarity with quality management systems (QMS) and electronic documentation systems.

Reference: 2888751973

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