Pharmaceutical Compliance Coordinator

vor 1 Monat

Penzberg, Bayern, Deutschland GULP – experts united Vollzeit

About Us

At GULP – experts united, we are dedicated to fostering a collaborative environment. We are currently seeking a talented Compliance Specialist to join our team within the pharmaceutical sector . We offer a competitive salary, personalized support, and excellent opportunities for professional growth. If you possess experience in process evaluation, qualification, and validation, we would love to hear from you.

What We Provide

  • Competitive salary and long-term job stability through group affiliation.
  • Comprehensive social benefits, including holiday and vacation bonuses.
  • Up to 30 days of vacation entitlement annually.
  • Tailored training programs with esteemed partners.
  • A broad array of employee benefits.

Key Responsibilities

  • Assist the Group Manager and other leadership in matters related to Quality & Compliance.
  • Prepare internal batch record reviews in collaboration with the product group manager.
  • Conduct risk-based evaluations of produced batches and coordinate root cause analyses and action tracking in case of deviations.
  • Maintain the internal release system (SAP-based) for digital batch storage.
  • Independently generate deviation reports in conjunction with relevant stakeholders.
  • Coordinate, process, and update internal manufacturing regulations with all pertinent partners.
  • Develop SOPs and specification documents.
  • Provide training to employees on compliance with the applicable quality management system when necessary.
  • Ensure proper filing and archiving of records and documents in accordance with current regulations.
  • Independently create and manage change requests (equipment) and coordinate necessary actions as per specifications.
  • Conduct tours of production areas.
  • Verify hygiene measures (hygiene plans) and follow up on actions resulting from monitoring limits being exceeded.

Candidate Profile

  • Degree in natural sciences (preferably a Master's in chemistry).
  • Ideally, professional experience in the pharmaceutical or chemical sector.
  • Familiarity with production and quality control processes within the regulated diagnostic/pharmaceutical industry.
  • Knowledge of relevant DIN ISO standards (13485, 9001) and other applicable regulations (e.g., GMP, IVDD, FDA QSReg).
  • Experience in process evaluation, qualification, and validation.
  • Proficient in German and possess good written and spoken English skills.

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