You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Vacancy details
Vacancy description:
Job Code:
J756662
Job Title:
Director of R&D Quality Assurance
Job Category:
Regulatory And Drug Safety
Contract:
Locum/Temporary
Discipline:
QA
Country:
United Kingdom
Location:
Berkshire, Hampshire, London - Central, Surrey, London - South
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
15 Aug 2008
Are you are looking to move to a Director level role? An excellent opportunity for a Quality Assurance specialist to join a growing pharmaceutical company based in Berkshire. In this role you will be responsible for ensuring quality awareness throughout the company, you will also deliver the company's R&D Audit Programme, and ensure that Clinical Trials supplies production and subsequent clinical trials are carried out in accordance with corporate standards, regulatory requirements and local laws. You will be responsible for the management of the Quality System for the company. This involves the following:
SPECIFIC RESPONSIBILITIES:
Responsibility for batch certification and release of Investigational Medicinal Products and cosmetic studies in compliance with GXP.
Assessing non-conformities and compliant findings and ensuring appropriate actions are agreed and followed up.
Authorising the disposition of non-conforming material, making judgement as to the effect on the final product and recommending appropriate course of action.
Rejecting or recommending rework / reprocessing of clinical supplies.
Releasing those products where (either legally or because of company procedures) authorisation by a Qualified Person is required.
Ensuring compliance of the quality documentation related to product release.
Maintaining a good working knowledge of the current regulatory requirements, corporate standards and local laws and ensuring this is disseminated throughout the company.
Represent a Quality Image for the company.
Responsible for the GMP in-house training programme.
SPECIFIC RESPONSIBILITIES:
DAY TO DAY:
Assist in production and updating of the Site Master File.
Assist in the management of Regulatory Inspections.
Implementation or management or an In-House Training Programme, as appropriate.
Review and approval of:-
Specifications
Validation protocols and Reports
Batch release documentation
Technology transfer file
Technical Reports
Protocols (Non-Clinical)
Standard Operation Procedures
Master BMR's
Audit Reports
Critical Deviations / File Notes
Batch Documentation and Clinical Trial Release
Acting as a source of advice and guidance on Quality / GXP issues
Implementation of quality audits :-
Internal
Technical Reports
Facilities
Systems
Self-Inspections
Directed or For Cause Audits
External
Investigator Sites
Sub-contractors
Suppliers
Directed or For Cause Audits
PROJECT MANAGEMENT:
Providing support to project teams on quality/regulatory issues.
HEALTH AND SAFETY:
Develop familiarity with the Health and Safety issues relevant to the above-stated position, observe the necessary health and safety procedures at all times thus ensuring the safety of yourself and of your colleagues.
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Site by Redder