Document Reviewer

Job description

  Location
Cramlington, Northumberland
·  Category
Office and Secretarial - Administrator
·  Job type
Permanent
·  Industry
Office and Secretarial
·  External Reference
EM-DR

My client based in Cramlington are looking for a Document Reviewer to join the business. This is a permanent position to work for a very successful business with fantastic opportunities and benefits for the right candidate. Experience of cGMP and quality systems would be an advantage however training in these areas will be provided.

Responsible for the review and retrieval of all process documentation.

Assist in the maintenance of OQ systems and to perform all work in accordance with cGMP and regulatory standards

HSE:

·  Comply with all HSE requirements including safety policies and procedures

·  Conduct HSE audits

Operational:

·  Conduct cGMP review of all process records

·  Conduct review of deviation reports

·  Issue reconciliations

·  Archive all documentation

·  Responsible for ensuring that Process Records specified by OQ Management are complete and comply with the relevant standards eg cGMP and regulatory standards and as defined in appropriate SOP.

·  Responsible for OQ checking and approval of Picking Lists as defined in appropriate SOP.

·  Responsible for controlling, issuing, reconciling. This includes ensuring that issues such as cleanouts, validation and trials have been taken account of and that issuing is done in line with production requirements. Update of SAP process record sheet module.

·  Responsible for performing initial batch release checks.

·  Responsible for compilation and filing of batch records including analytical data and raw material reports.

·  Responsible for photocopying/faxing of batch records as required by external customers.

·  Responsible for archival of monographs.

·  Responsible for update of master cabinets and issuing of controlled copies to plant.

·  Responsible for collection/filing of PCARs.

·  Checking and logging of clean room data.

·  Preparation of draft Annual Clean Room Reports.

·  Preparation of draft APQR's.

·  Logging of Change Controls, ADRs, PDRs, OOSIRs, RAs and CAPAs.

·  Generation of summary reports for customer as required.

Quality/cGMP:

·  Will uphold cGMP principles in his/her area of responsibility, continually seek opportunities to improve and enhance quality standards, and encourage other staff to do likewise.

Contacts & Relationships:

·  Daily contact with all Quality personnel

·  Contact with operational staff for the provision of documentation.

Other Important Factors:

·  Must be a self starter, extremely reliable and recognise the importance of documentation compliance within the requirements specified in cGMP

Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.

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