Quality Specialist - QMS

Highly Competitive
Maidenhead, Berkshire
Posting date: 14 Nov 2018
This vacancy has now expired

Our client is a rapidly growing pharmaceutical company with headquarters in Central London. They are currently seeking a Quality Specialist to work within their QMS group. Reporting to the Quality Manager (QMS), the Quality Specialist will be responsible for supporting the creation, maintenance and improvement of the global Quality Management System. You will ensure that the Quality Management System (QMS), Document Management System and their associated processes are robust, compliant, efficient and suitable for the company needs, present and future.

Job Responsibilities:

  • Support the management of the QMS and associated processes through ensuring that:
    • SOP's for all relevant departments are issued, compliant, appropriately trained and regularly reviewed.
    • Appropriate GxP training is scheduled and recorded
    • Processes are in place for recording, monitoring and trending complaints, change control, CAPA and deviations.
    • Document retention policies are defined and adhered to.
    • A self-inspection schedule is created and maintained.
    • A Quality Manual and Quality Policy is maintained
  • Establish a close working relationship with all internal stakeholders.
  • Support the maintenance and administration of an efficient electronic Quality Management System and Document Management System.
  • Support on-site audits by Regulatory Authorities and, where required, Customers.
  • Keep up to date with the latest Regulations and support their implementation.
  • Author and approval of Standard Operating Procedures.

Skills and Requirements:

  • Experience working in Quality Assurance within the Pharmaceutical or highly regulated industry.
  • Broad experience of all areas of Quality Assurance Quality Management Systems.
  • Experience of managing or administering electronic Quality Management Systems and / or Document Management Systems.
  • Working Knowledge of the Pharmaceutical GxP regulations.
  • Knowledge of GAMP / Validation principles.
  • Experience of successfully supervising or leading employees.
  • Able to foster strong cross-functional relationships.
  • Strong influence, interpersonal, verbal and written communication skills.
  • Excellent organisation skills and attention to detail
  • Able to respond positively to, and effectively implement, change.
  • Digitally Savvy
  • A level or equivalent in a scientific subject

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44 203 8261 330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.