Senior Compounding Quality Assurance Technician

Additional Information

Salary: up to 27,000pro rata

Hours: 40 hours per week

Support the quality assurance & quality control functions related to the manufacture of compounded aseptic products and compounded or assembled investigational medicinal products. Carry out day to day quality assurance & quality control operational activities within the compounding unit and warehouse

Key Responsibilities

* Quality Assurance and Quality Control Senior Technician cover cover specified work of other QC personnel
* Environmental monitoring undertake microbiological and physical environmental monitoring according to the schedule
* Validation
* Microbiological sample handling

* Review and complete sample documentation.
* Incubate samples at specified temperatures for specified periods.
* Examine samples and perform colony counts.
* Process samples for submission to contract laboratory for organism identification.
* Perform viable counts using aseptic technique (for transfer validations).

* Microbiological reporting

* Log all results in the relevant Excel report
* Raise Non Conformance Reports (NCRs) for all warning and action limits exceeded.

* Chemical analysis undertake limited chemical analysis on specified samples.
* Laboratory cleaning undertake laboratory and equipment cleaning.
* Non Conformance (Deviation) Reporting :

* Check each NCR has been completed adequately and has been signed by a pharmacist
* Complete assembly of all relevant associated documentation e.g. batch records and prescriptions with each NCR report
* Pass reports to the Senior Technician Quality Assurance for screening and further investigation
* Log NCRs on Q-Pulse

* Starting materials and Specials process batches against specifications quarantine and submit for approval rejection
* Packaging materials process batches against specifications quarantine and submit for approval / rejection
* Cleaning and disinfection materials process batches against specifications quarantine and submit for approval rejection.
* Laboratory samples quarantine miscellaneous samples for investigation.
* Stock replenishment proactively identify and replenish devices and supporting materials to support smooth running of operations. Use first in first out rotation to support cost effective use of inventory

* Cleaning and disinfection all team members must clean areas in line with schedule and proactively clean own area of work when required. Use approved disinfectant agents and techniques to reduce and control microbiological risk
* Quality Directives Work to the company quality directives supporting compliance and risk managed processes
* Requirements

* Educated to at least NVQ Level 3 in Pharmaceutical Services or an equivalent qualification.
* Recent experience and training in current GMP
* Recent experience and training in aseptic technique

To be appointed as an Assistant

* Educated to at least NVQ Level 2 in Pharmaceutical Services or an equivalent qualification or
* 6 GCSEs including maths and sciences
* Preferably A levels