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Senior Quality Assurance Officer

2 months ago

Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time
Job Summary

We are seeking a highly skilled Senior Quality Assurance Officer to join our team at Select Pharma Limited. As a key member of our Quality Assurance department, you will play a critical role in ensuring the highest standards of quality in our pharmaceutical products.

Key Responsibilities
  • Quality Management System (QMS) Administration: Oversee the preparation, review, and approval of standard operating procedures (SOPs) to ensure compliance with regulatory requirements.
  • Batch Release and Quality Control: Perform batch release as per SOP, ensuring that all products meet the required quality standards.
  • Regulatory Compliance and Audits: Participate in regulatory inspections and customer audits, ensuring that our facilities and processes meet the highest standards of quality and compliance.
  • Process Validation and Qualification: Conduct process validation, cleaning validation, and transport validation, as well as equipment and utility qualification, to ensure that our processes are robust and reliable.
  • Internal Audits and Training: Perform internal audits and provide training to ensure that all employees understand their roles and responsibilities in maintaining high-quality products.
  • Documentation and Record-Keeping: Prepare and maintain batch records and other documentation related to quality assurance.
Requirements
  • Experience: Proven experience in a similar pharmaceutical quality assurance role, with a strong understanding of regulatory requirements.
  • Skills: Excellent communication and IT skills, including proficiency in MS Word, Excel, and PowerPoint.
  • Teamwork and Problem-Solving: Ability to work effectively as part of a team and demonstrate a problem-solving attitude.