GMP Specialist

Hobson Prior

  • Leiden, Zuid-Holland
  • Interim
  • Voltijds
  • 10 dagen geleden
We are seeking a highly skilled and experienced GMP Specialist to join our Supply Chain Department in Leiden. The ideal candidate will have a strong background in pharmaceutical manufacturing, excellent knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and understanding of Supply Chain. This role is critical to ensure the integrity of our supply chain processes and maintain compliance with industry standards, providing strategic oversight, operational guidance, and risk management in a complex and highly regulated environment.Please note that to be considered for this role you must have the right to work in this location.Your mission
  • GMP Compliance: Act as the primary point of contact in EU Supply Chain for Quality Events, responsible for Deviation Management, Change Control, CAPA and complaints. Design and follow-up of effectiveness check.
  • Ensure all Supply Chain activities comply with GMP regulations and standards. Implement and monitor GMP practices across the department.
  • Quality Assurance: Collaborate with the Quality Assurance team to develop and enforce quality standards and procedures. Conduct and support regular audits and inspections to ensure compliance.
  • Maintain accurate and detailed records of supply chain activities, ensuring all documentation meets GMP requirements.
  • Responsible for authoring and reviewing Standard Operating Procedures (SOP) and Work Instructions (WI).
  • Keep Corrective and Preventive Actions (CAPA) actions, conduct Impact Assessments, and drive Change Controls as needed.
  • Training and Development: Provide training to supply chain staff on GMP practices. Develop and update training materials as necessary.
  • Risk Management: Identify potential risks in the supply chain and develop mitigation strategies. Conduct root cause analysis for any issues and implement corrective actions.
  • Collaboration: Work closely and act as mediator with cross-functional teams, including Global Supply Chain, Quality Assurance (QA), Quality Control (QC), EU Manufacturing, EU Site Management, EU Tech support, MSAT, and IT to ensure seamless integration of supply chain processes.
  • Process Improvement: Identify areas for process improvement within the supply chain. Lead and manage continuous improvement projects to enhance efficiency and reduce waste.
Requirements:
Education & Experience:
  • Minimum of 8 years of experience in the pharmaceutical industry, with a strong focus on GMP processes.
  • Bachelor's degree in pharmacy, Chemistry, Engineering, or a related field. Advanced degree preferred.
  • Experience with Good Distribution Practices (GDP) is a need.
  • Experience with SAP or equivalent ERP system required.
  • Experience with pharmaceutical Quality Management Systems (QMS) required.
Competencies:
  • In-depth knowledge of GMP regulations and standards.
  • Excellent written and verbal communication skills in English.
  • Ability to work independently and as part of a team.
  • Strong organizational and project management skills.
  • Familiarity with supply chain management software and tools (ERP'S).
  • Proficient in Microsoft Office Suite.
For more information, please contact Grant Van Schalkwyk.If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - .

Hobson Prior