CAPA and Deviation Specialist

vor 2 Wochen

Bielefeld, Nordrhein-Westfalen, Deutschland SciPro Vollzeit

Job Title: CAPA & Deviation Specialist

Job Type: Full-time (2 days onsite, 3 days home office)

Duration: Permanent (Mostly office-based during the start)

Job Summary:

We are seeking an entry-level CAPA & Deviation Specialist with up to 1/2 year of experience in a GDP-regulated environment. This role will focus on managing deviations and CAPAs within the pharmaceutical processes, with a strong emphasis on GDP knowledge. Fluency in both English and German (B2) is required, as the role involves communication with German-speaking customers.

Key Responsibilities:

  • Deviation Management:
  • Assist in investigating and documenting deviations following GMP and GDP guidelines.
  • Support the CAPA process by helping with root cause analysis and ensuring actions are implemented.
  • Support for CAPA Processes:
  • Collaborate with the quality management (QM) team and ensure proper tracking of CAPA actions.
  • Communicate effectively with the Responsible Person to ensure CAPA closure and effectiveness.
  • Employee Reporting:
  • Work closely with basic team members in the deviation & CAPA team, who report to the QM team.
  • Report directly to the Responsible Person or pharmacist in charge.
  • GDP Services:
  • Ensure compliance with GDP within all assigned tasks.
  • Training & Compliance:
  • Attend and assist in delivering training sessions on deviation management, CAPA processes, and GDP compliance.

Qualifications:

  • Bachelor's degree in Life Sciences, Biochemistry, Pharmacy, or a related field.
  • 1/2 years of experience in CAPA or deviation management, preferably in a pharmaceutical environment.
  • Knowledge of GDP regulations.
  • Fluency in English and German (B2 level or above).
  • Strong communication and organizational skills.

Preferred Qualifications:

  • Experience in pharmaceutical or life sciences industries.
  • Previous exposure to employee training programs.

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