Job Description

Responsibilities include;

• Conduct appropriate audits to schedule to verify conformance to documented procedures, CCPs and GMP

• Record and investigate non-conformances. Report specific details to the relevant operational management and agree the necessary corrective actions, timescales and responsibilities
• Conduct formal reviews of corrective action status with immediate line manager
• Verify effectiveness of daily deep cleaning through inspection, rapid hygiene and traditional environmental swabbing
• Carry out appropriate pre-production checks to ensure timeliness of start up
• Daily in-process monitoring of all CCPs to validate product safety

• Collect Key Performance Indicator data with a view to developing statistical measurements of business performance.
• Collect microbiological samples against company sampling plan.
• Conduct investigations and ensure appropriate corrective action in the event of customer complaints.
• Organise daily product monitoring analysis panels to verify conformance to specification. Compile data for further analysis.
• Ensure that quarantine procedures and necessary accompanying paperwork are completed on a routine basis.

• Verify document control systems
• Use the daily production plan & raw material sheets to ensure that all retail products and part processed raw materials are collected for microbiological and shelf life analysis.
• Conduct quality checks against the specifications for all relevant products & processes
• Ensure that all shelf life samples are kept for the duration of their life against the agreed time / temperature regimes and that the area where they are stored is kept clean and free from out of date samples
• Report any out of specification results to the QA Manager and / or Technical Manager

• Quarantine products / equipment as necessary and take the necessary follow up action.
• Ensure that microbiological samples are sent out against the predefined schedules and that the samples are logged onto the LIMS system and the registration files are sent through to the External Laboratory.
• Conduct daily / weekly / periodic calibration against schedules and that any out of specification results are actioned accordingly.
• Conduct any tests as requested by the QA Manager / Process Development Technologists from any factory trials

Required Knowledge, Skills, and Abilities