Senior Quality Assurance Specialist

2 weeks ago

Hoddesdon, Hertfordshire, United Kingdom Pharmaron Full time

About the Role:

We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Pharmaron. As a key member of our Quality Assurance department, you will be responsible for implementing and maintaining a compliant and effective electronic Quality Management System (eQMS) to support the integrity of our production processes and systems.

Key Responsibilities:

  • Develop and implement SOPs and other controlled documents to ensure compliance with regulatory requirements.
  • Manage the issuance of SOPs and other controlled documents to ensure timely and accurate distribution.
  • Conduct internal audits to ensure compliance with regulatory requirements and identify areas for improvement.
  • Perform periodic reviews of Quality Systems, including Deviations and Vendors, to ensure compliance and identify areas for improvement.
  • Support the Vendor Management process, performing Vendor Qualifications, Vendor Audits, and Vendor Reviews to ensure compliance and identify areas for improvement.
  • Assist with preparation and provide support for audits by regulatory authorities, such as the MHRA.
  • Ensure Deviations, Change Controls, and OOS are tracked and investigated to ensure compliance and identify areas for improvement.
  • Investigate Quality issues and trends and contribute to continuous improvement initiatives.
  • Follow up on CAPAs to ensure timely completion of actions and ensure status visibility.
  • Administer the Training System, providing guidance to the Departmental Training Coordinators and managing the Training Matrix.
  • Manage the Archiving of GMP documentation.
  • Promote and contribute to a best-in-class Quality culture based on collaboration and continuous improvement.
  • Provide Quality representation and input at project and planning meetings.
  • Review Batch Records to ensure compliance and identify areas for improvement.
  • Provide Customers with high-quality service and products.
  • Create and encourage a transparent and trustworthy environment.
  • Perform roles and duties in accordance with current Good Manufacturing Practice guidelines and principles, and Pharmaron Policies, Standard Operating Procedures, and Supporting documents.
  • At all times uphold the highest professional standards and act in the interest of the patient/patient safety.
  • Ensure both initial and continued personal training is carried out and adapted according to need.
  • Ensure all employees are suitably trained in all processes before undertaking where appropriate.
  • Encourage continuous improvement through an effective Quality Management System (QMS) striving to improve processes and practices.
  • Promote and contribute to a best-in-class Quality culture and reputation based on collaboration.
  • Promote leadership collaboration and employee engagement with the same Quality goals ensuring GMP compliance.
  • Promote the culture that 'Quality is everyone's responsibility.'

Requirements:

  • A minimum of a BSc degree in chemistry or related science subject area.
  • Minimum 2 years' experience in Quality Assurance within a Pharmaceutical environment.
  • Experience of eQMS administration or management.
  • Knowledge of current GMP guidelines and industry trends regarding data integrity.
  • Knowledge of Eudralex Volume 4 Part I and Part II.
  • Organizational skills.
  • Leadership skills.
  • Able to communicate effectively at all levels within a large organization.
  • MS Project and Office Experience.

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