1.The primary responsibility of a QC Analyst is to compliantly perform laboratory testing, data review and data interpretation in accordance with approved SOPs. It is expected that analysts consistently work to the highest standards of cGMP (as defined in the EU GMP Annexes and FDA CFRs) and in accordance with the uppermost standards of HSE.
In addition to testing, Analysts will be required to perform raw material and components inspection (quality receipt) and sampling.
It is the responsibility of QC Analysts to communicate their findings as a result of testing promptly, to the QC Analytical leadership team (Team Coordinators and Manager). Specifically, it is expected that deviations (either out of specification results or compliance gaps) are highlighted to a leadership team member immediately as they are recognised.
2.It is the responsibility of QC Analyst, when assigned, to complete critical tasks such as:
*Instrument Maintenance and Calibration
*Sampling booth cleaning and monitoring
*Reagent and Standard Qualification
*Initiation of deviations
*Initiation, and completion, of CAPAs
*Completion of Change Control actions
*Updates and reviews of SOPs
*Participation in quality risk assessments
3.It is the responsibility of QC Analysts to participate in laboratory administration tasks such as:
*HSE risk assessment completion, review and adherence
*Archiving of laboratory documentation,
*Ordering of reagents and consumables
*Maintenance of QC sample and reagent stores
*Ensuring a clean and safe workplace for all associates
4.It is the responsibility of QC Analysts to proactively maintain their own training records, and to only perform tasks that they have confirmed themselves to be compliantly trained in, in accordance with local SOPs
5.It is the responsibility of QC Analysts to ensure that they communicate professionally and effectively with their fellow team members and the QC Analytical leadership team.
*Analysts will have no direct reports for whom they are responsible.
*Analysts will be directly accountable for the quality of their work in accordance with the defined standards
*Analysts will be responsible for reporting deviations or non-compliances immediately to the QC Analytical leadership team
*Analysts will have an indirect responsibility for budget adherence and cost saving realisations.
QC Analysts are considered to be a key member of the Quality team in supporting timely product testing and release.
*Analysts will routinely liaise with other members of QC and QA to ensure completion of work and compliance
*Analysts will routinely liaise with Supply Chain planning team members to ensure correct prioritisation of testing
*Analysts will represent the department at inter-departmental meetings as required by the leadership team
E. Key Relationships
Key internal relationships for a QC Analyst include:
*Fellow QC Analytical team members, including Analysts, Team Coordinators, and Manager
*QC Bioassay, QC Microbiology, QC Validation, QC Stability and GLIMS team members
*QA team members
*Internal Engineering team members
*Manufacturing team members
*Supply Chain team members
Key external relationships for a QC Analyst include:
*External instrument engineers
*Reagent and Consumable suppliers (Both on site representatives and off site third parties)
F. Decision Making
QC Analysts are expected to identify, highlight and participate in solving complex problems relating to:
*Testing or equipment issues
*Failures of test criteria resulting in aborted or invalid testing sessions
*Breaches of specification (internal or registered)
*Compliance gaps or breaches
In addition to this expectation, it is required that analysts appropriately prioritise problems using a quality risk based approach.
It is acknowledged that the complex cGMP working environment has limits to the extent to which innovations may be immediately implemented, however QC Analysts are expected to highlight deficiencies or possible improvements such that they may be reviewed for potential implementation with the QC innovations team.
In addition it is expected that QC Analysts own innovations or aspects of innovations, which have been deemed to be suitable for implementation, through to completion.
H. Knowledge, Skills & Competencies
QC Analysts must be fluent in English as the primary operating and reporting language used within the industry, in addition they must:
*Have experience in QC testing techniques appropriate to their role
*Have experience in cGMP application
*Have an awareness of the requirements for equipment and method validation
*Have awareness of root cause analysis
*Be computer literate and be able to demonstrate an understanding of electronic systems
QC Analysts must be educated to NVQ level 2 or equivalent in a relevant scientific discipline
QC Analysts must be have experience in the relevant testing discipline, ideally within the pharmaceutical industry having worked to cGMP standard
Adecco is acting as an Employment Business in relation to this vacancy. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
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