Regulatory Compliance Specialist for Biotech Company

vor 2 Wochen


Lugano, Tessin, Schweiz Pharmiweb Vollzeit

Are you passionate about ensuring the accuracy and compliance of batch records in a dynamic biotechnology environment? Look no further We are seeking a highly skilled Regulatory Compliance Specialist to join our team at a leading biotech company.

In this role, you will play a crucial part in maintaining high-quality standards and supporting the release of products. If you have a keen eye for detail, excellent communication skills, and a strong understanding of GDP and GMP regulations, we want to hear from you

Key Responsibilities:

  • Review and verify executed electronic Batch Records, including cleaning logs, production documentation, temperature reports, and test procedures.
  • Address and clarify comments added to executed Batch Records with the operations team and QA Manager.
  • Investigate and resolve deviations and observations related to Batch Record review.
  • Support the preparation of documentation packages for fast release by QA.

Requirements:

  • Experience in GDP and GMP regulated pharmaceutical or API industry.
  • Ability to identify non-compliance and gaps from quality standards.
  • Strong communication and interpersonal skills.
  • Structured and organized working attitude.
  • Knowledge of MES Syncade and DeltaV systems is a plus.
  • Salary Estimate: $80,000 - $110,000 per annum, depending on experience.

What We Offer:

  • A dynamic and supportive team environment.
  • Opportunities for growth and professional development.
  • A competitive salary and benefits package.

Are you ready to take your career to the next level? Apply now and join our team of dedicated professionals



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