Biotechnology Quality Assurance Specialist

2 weeks ago


Longford, Ireland Quanta Consultancy Services Ltd Full time

We are seeking a highly skilled Biotechnology Quality Assurance Specialist to join our team at Quanta Consultancy Services Ltd. As a QC Bioassay Analyst, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.

About the Role

You will work as directed by the Bioassay Manager / Associate Director, according to Company safety policies, cGMP and cGLP. Your primary responsibility will be to drive compliance with Global policies, procedures, and guidelines, and regulatory requirements while executing Good Manufacturing Practices (cGMP) in day-to-day activities.

Key Responsibilities
  • Develop, implement, and maintain procedures that comply with appropriate regulatory requirements.
  • Ensure that all Quality Systems within the department are adhered to on a daily basis.
  • Comply with Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in day-to-day activities.
Requirements

To be successful in this role, you will need:

  • Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
  • Knowledge of cGMP.
  • Laboratory Quality Systems.


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