Quality Systems Specialist / Validation Specialist

South East England  ‐ Onsite
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Description

There is an amazing opportunity for an experienced Validation Specialist to join a state of the art high capacity manufacturing facility for an established Pharmaceutical company in the Southeast. The Validation specialist will work in supporting Pharmaceutical manufacturing, with respect to the execution of validation activities

Salary: £39,000

You will provide expert guidance to all departments in the development of validation strategies. Implement efficient and effective execution of validation procedures. You will ensures that all Quality System activities of the facility comply with the current Corrective and Preventive Action (CAPA) exception and Product Quality Review reporting processes. Tracks effectiveness of CAPA process through metric reporting and generates Product Quality Reviews for API and Pharmaceutical Products in line with EU GMP and FDA guidelines.

Main responsibilities will be to:
  • Manage and schedule validation and requalification activities for GMP facilities for the Facilities Validation Department.
  • Represent validation during Site Inspections.
  • Ensures that the facility maintains its compliance status by identifying areas for improvement and future challenges relating to the validation and PQR processes.
  • Continuous improvement of validation systems and procedures to ensure efficiency and best practice within the industry and to stay abreast of changing regulatory expectations.
  • Provides PQR training.
  • Providing a reliable service to our internal customers to ensure that timescales are met and work is carried out to meet expectations.
  • Communicating validation activities with our internal and external customers and working with them to resolve problems and conflicts.
  • Undertake all work in accordance, code of Safety Practice and site Quality Policies.


The Position is very important, as you will be providing leadership and coordination in support of validation activities. The ideal candidate will have a honors degree in a scientific discipline and have significant Pharmaceutical and GMP experience. A comprehensive understanding of Regulatory requirements e.g. FDH, MHRA, ICH.

Thorough knowledge of the Validation Lifecycle and a wide range of Validation experience in production, Laboratory or Quality Assurance.

Candidates must be eligible to work in the UK to be considered for the position.
Start date
09/2015
From
Real Staffing
Published at
29.07.2015
Project ID:
955092
Contract type
Permanent
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