* Job Title –Quality Assurance Associate
* Location –Slough
* Contract Length – initial 6 months
* Pay Rate- 23.06 is max rate – depending on experience
Roles and Responsibilities
o Issuing of approved/ effective GMP documents for use in Manufacturing (entering the unique document ID based on the issue list, printing from DMS and signing the issue list) ensuring that Manufacturing deadlines are met.
o Printing of labels for use in the Manufacturing process, including finished product labels.
o Checking accuracy of issued documentation and labels
o Issuing of effective logbooks as required according to GMP procedures.
o Printing and issuing other GMP documentation as required meeting business timelines
o Co-ordinate the consolidation of all the QC testing activities
o Perform an independent check that all the relevant activities have been completed and all release specifications have been met.
o Perform Batch Consolidation duties with regard to QC Biochemistry and Microbiology testing activities for Drug Product and Drug Substance.
o Liaise with internal customers to ensure receipt of required informationand maintain effective interdepartmental communication and collaboration.
o Work with the QA Operations team members, Manager and Team Leaders to enable continued improvement to QA quality systems / processes.
o To continually identify and implement improvements in safety, GMP compliance and efficiency.
o Leading and management of quality records e.g. Deviations, CAPA, Change Controls, Investigations
o Authoring, Reviewing and approving GMP documentation
o Prioritizing workload to ensure deadlines are met.
o Acting as a point of contact for general queries relating to issuing.
o Maintenance of issuing supplies to ensure that materials are always available to enable on time issuing of documents.
o Maintenance the archiving system by checking received boxes adhere to GMP procedures, arranging for box collection and coordinating box retrieval as required.
o Maintenance of training profile, ensuring that all required training is completed prior to performing an activity.
o Other duties as assigned.
Skills Required
o IT literate (MS Office – Word, Explorer, Excel, Access, Outlook) familiarity with database entries
o Verbal and written communication skills
o Risk based decision making
o PQS experience
o Accurate data entry skills, high attention to detail
o Demonstrated workload prioritization skills, decision making and scheduling skills
o Ability to meet strict deadlines
o Good organizational and planning skills.