Senior QP - IMP Release & GMP Quality Lead

SUN PHARMA; Hoofddorp; On-site; EUR 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Hoofddorp is seeking a Senior Qualified Person to ensure the release of Investigational Medicinal Products (IMPs) for clinical trials. The candidate will be responsible for maintaining compliance with European and international GMP standards and will provide mentorship on quality assurance practices. The ideal applicant should possess a relevant degree, QP certification, and a minimum of 5 years of experience within the pharmaceutical industry, coupled with strong problem-solving and communication skills. This role involves cross-functional collaboration and oversight of quality management activities.

Qualifications

• 5+ years of experience in Quality Assurance or similar role in the pharmaceutical industry.
• In-depth knowledge of EU GMP, GCP, and regulatory requirements for clinical trials.
• Excellent written and verbal communication skills in English.

Responsibilities

• Certify the release of Investigational Medicinal Products (IMPs) for clinical trials.
• Provide quality oversight of manufacturing and testing activities.
• Review and approve batch manufacturing records and validate protocols.
• Stay updated on evolving EU and international GMP regulations.
• Provide training to Quality Assurance staff on GMP and quality requirements.

Skills

Problem-solving

Analytical skills

Communication skills

Interpersonal skills

Education

Bachelor’s or Master’s degree in Pharmacy, Biotechnology, or Chemistry

QP Certification recognized under EU Directive 2001/20/EC

Job description

A leading pharmaceutical company in Hoofddorp is seeking a Senior Qualified Person to ensure the release of Investigational Medicinal Products (IMPs) for clinical trials. The candidate will be responsible for maintaining compliance with European and international GMP standards and will provide mentorship on quality assurance practices. The ideal applicant should possess a relevant degree, QP certification, and a minimum of 5 years of experience within the pharmaceutical industry, coupled with strong problem-solving and communication skills. This role involves cross-functional collaboration and oversight of quality management activities.