PCR Administrator

Job Overview

Issuing of working documentation to Production Departments, Maintain a record of all documents issued and ensure only current copies are made available for each area through the maintenance of a secure and controlled filing system. Maintain Training Matrix and trainings files of personnel within Production Department.

Main Activities/Tasks

• Maintain a record of all documents issued and ensure only current copies are made available for each area through the maintenance of a secure and controlled filing system.
• Issue and reconcile logbooks as Responsible Employee in line with Data Integrity guidelines and Good Documentation Practices and liaise with Manufacturing Supervisors documentation quality and discrepancies.
• Undertake role of SOP Custodian and act as the point of contact for the Data and Document Control Department to facilitate the issuing and reconciliation of the SOP’s in Production Department.
• Maintain a Training Matrix, training record files of personnel within Production Department and issue training documentations for completion.
• Ensure records in received training sheets documents were entered in line with Good Manufacturing Practice, Good Documentation Practice and Data Integrity guidance.
• File Stop For Excellence documents, Memorandums and any other required documents in an organised and effective manner.
• Archive GMP associated documentation in accordance with authorised procedures ensuring that all documentation is indexed and catalogued in organised manner permitting efficient retrieval.
• Provide comprehensive clerical and administrative support, either within the team unit or individually.
• Co-ordinate and implement office procedures, ensuring that the work area is maintained in an organised state.
• Issue keys to lockers in changing room to new production personnel.
• Reporting through the QA Department, you will have the responsibility to approve and control the issuing of Working Copy Documents for the recording of data within the GMP environment.
• Review of received GMP documents ensuring records were entered in line with Good Manufacturing Practice, Good Documentation Practice and Data Integrity guidance.
• Convert existing Production Control Records to a new template layout as advised.
• Provide comprehensive support to a training sessions conducted by Production Department, either within the team unit or individually.
• Carry out any other duties as deemed necessary by Management

Essential Criteria:

• Educated to at least GCSE level with grade C or above in English and Maths or equivalent
• Have relevant experience within an Administration role, demonstrating the use of Microsoft packages e.g. Word and Excel
• Excellent communication skills
• Excellent organisational skills along with a proven ability to meet deadlines.

Duration: Perm
Location: Newry

Additional Information:

• Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. 
• applications received after the closing date will not be accepted.
• We are unable to sponsor at this time.

Benefits:

• Free Life Assurance
• Company Pension - salary sacrifice scheme
• Healthcare cash plan
• 32 days annual leave
• Wedding Leave
• Company Sick Pay
• Company Maternity / Paternity
• Paid bereavement leave
• Cycle to Work Scheme
• Employee Savings scheme
• Employee well-being initiatives
• Employee Assistance Programme
• On-site free parking
• Subsidised Canteen Facilities
• Employee Perks scheme
• Employee Recognition scheme
• Career Development