Qualified Person

Szczegóły stanowiska

Are you an experienced Qualified Person (QP) looking to advance your career in a dynamic and fast-paced environment? We are seeking a dedicated QP to join our client's team and ensure the highest standards in medicinal product certification and compliance.

**Key Responsibilities:**

  • - Certify medicinal product batches for sale, distribution, or clinical trials.
  • - Ensure compliance with EU-GMP and relevant legislation.
  • - Supervise operations to maintain legal compliance.
  • - Coordinate with production, quality control, quality assurance, and supply chain teams.
  • - Manage records, change controls, and subcontracted activities.
  • - Handle GMP-related customer complaints and integrate GMP aspects into the quality management system.
  • - Oversee risk assessments, audits, and inspections.

**PPS Specific Duties:**

  • - Ensure compliance with regulatory requirements and support the Morpeth Site Quality Review Team.
  • - Provide QP support and guidance on Dutch Health Authorities' requirements.
  • - Participate in the PPS Morpeth site Quality Management Review Team and champion the Quality Agenda.

**Authorities:**

  • - Stop operations that do not comply with quality systems or legal requirements.
  • - Release or reject raw materials and finished products.
  • - Approve GMP suppliers and quality contracts.
  • - Initiate recalls and inform competent authorities about product issues.

**Qualifications:**

  • - Diploma or equivalent in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology.
  • - At least two years of practical experience in qualitative and quantitative analysis of medicinal products.
  • - Recognized by the Dutch Health Authority (IGJ) and listed on the Manufacture and Import Authorisation.
  • - Proficient in EU GMP regulations and experienced in operating an EU regulatory approved QMS.
  • - Strong collaboration skills and ability to work independently.
  • - GMP auditing knowledge and practical skills.

**Skills:**

  • - Robust technical knowledge of EU GMP and regulatory guidelines.
  • - Highly collaborative with senior management, regulatory groups, and other stakeholders.
  • - Ability to work under pressure in a fast-paced environment.
  • - Good team player with a positive attitude and flexibility.

**Other Requirements:**

  • - Eligible to act as a Qualified Person under EC/2001/83 Directive.
  • - Experience as a certifying QP for solid unit dose products, IMPs, sterile products, and narcotic products.
  • - Minimum C1-level proficiency in Dutch and English.

**Working Conditions:**

  • - Office-based with work-from-home flexibility.
  • - Some travel for audits within the EU and occasionally globally.
  • - Reports to the Lead QP (NL).

**To Apply:**
Submit your resume and cover letter to Izabela.Krajewska@reed.com

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