Senior QA Officer - Technical

Senior Quality Officer- Technical
Permanent
Bridgend
Salary: DOE

My client based in Bridgend have an exciting position for a Senior Quality Offiver to join them.

This is an opportunity to join a global company who offer a fantastic benefits package.

The main purpose fo the role will be to perform a Quality Assurance role which supports:
Certification and release of medicinal products in accordance with regulatory, company and project requirements.
Maintain, support and improve the Pharmaceutical Quality System

In order to do this, your main responsibilities will be:
Support the QP in execution of their legal and operational duties, execution of delegated activites.
Administration, control and support core systems within the Pharmaceutical Quality system as allocated by line manager. Including but not limited to Internal audits, supplier management, deviations/complaints, CAPA, change control activities and document control.
Overseeing of site licences.
Participate in client and regulatory audits of the facility.
Generate and approving PSF and technical documentation.
Represent the Bridgend Quality department for key client accounts, client enquiries and attending client calls.
Support delivery of site/departmental projects and objectives.
Support continuous improvement projects and opportunities.
Author standard operating procedures.
Provide QA and GMP related training

In order to be succesful in this role you will need:
HNC, HND or degree (or equivalent) in a life sciences subject or suitable experience in a Quality Assurance or technical role within the pharmaceutical industry.
Experience in a Quality role within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
Experience generating, reviewing protocols, reports or technical documentation within a regulated industry.
Experience in a Quality Assurance role within an industry with transferable skills.
Specific Knowledge / Skills Competence:
Good GMP knowledge and experience of EU legislation and guidelines; experience with FDA GMP requirements CFR 210 and 211 other regulatory guidelines preferable.
Strong communication skills.
The ability to introduce, co-ordinate, complete and report on projects.
A high level of self-motivation is required
Able to rationally persuade.
Influencing skills
Ability to perform audits, internally and externally.
Quality Officers need to be familiar with standard computer applications currently in use by the company.


If you feel you have the right skills and experience please get in touch asap

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