Quality Assurance Process Manager

7 hours ago

Cork, Cork, Ireland beBeeValidation Full time €90,000 - €105,000
Job Title: Qualification & Validation Specialist

Hovione is an international Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

The successful candidate will be responsible for defining and implementing procedures and processes to assure that facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards.

  • Define and implement procedures and processes to ensure compliance with quality standards.
  • Assure cGMP compliance before, during and after validation/qualification activities of systems/equipment and manufacturing processes.
  • Qualify and validate systems/processes/methods according to their intended use and product requirements.
  • Promote high-quality levels and a continuous improvement culture in core company activities.

Key responsibilities include:

  1. Developing and implementing qualification and validation procedures.
  2. Conducting risk assessments and ensuring compliance with regulatory guidelines.
  3. Collaborating with cross-functional teams to align qualification and validation methodologies.
  4. Participating in conceptual, basic and detailed design reviews for projects.
  5. Providing input to plan and establish qualification and validation requirements for each project.

Required qualifications include:

  • University degree in Chemistry, Chemical Engineering, Mechanical Engineering or similar scientific field.
  • Typically 3-5 years of relevant experience in Quality and Qualification and Validation.
  • Strong understanding and knowledge of Quality, Engineering, cGMP, ICH and ISO guidelines.

A competitive remuneration package including medical insurance benefits is offered. Hovione values diversity and inclusion in the workplace.

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