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Quality Assurance Representative

Eingestellt von TM Recruit

Gesuchte Skills: Support


As Quality Assurance Representative (QAR) you will provide assurance that manufacturing is carried out in accordance with cGMP and Regulatory commitments and that production records provide full and accurate documentation of batch manufacture in accordance with the relevant SOPs.

As Quality Assurance Representative you will be authorised to disposition materials with consideration being given to the Regulatory requirement for QP release of veterinary and medicinal products. You will also exercise control over the general cGMP activities for each of the teams you are responsible for.

In addition as Quality Assurance Representative you will monitor trends and identify problems in quality of purchased materials, packaging, intermediates, products, water and environmental data. You will also write and approve quality documentation eg batch production records, specifications, procedures (Team and Site), PMIS sheets and Stability protocols. Similarly you will review and approve SOPs (Team and Site), change control documentation, validation protocols, completed validation packages, IQ/OQ/PQ protocols.

You will also participate in self-inspections and other audits of the manufacturing and relevant Support areas with particular reference to cGMP as defined by the various regulatory authorities. As Quality Assurance Representative will also provide training, support, advice and proactive assistance in the Site Quality systems to the product and support teams.

To be successful as a Quality Assurance Representative you absolutely must have previous experience of working with a Pharmaceutical or Chemical Manufacturing QA or QC Environment. You will also have a degree in a science discipline and previous experience in a similar GMP related role eg Regulatory Affairs.

For this role batch release experience is also essential.

You will have a great understanding of current GMP requirements as well as good self-management skills, organisational and interpersonal awareness and excellent written and communication skills.

You should also be effective at building and maintaining great working relationships with internal and external customers globally.


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