Qc Analyst - Merseyside, United Kingdom - Adepto Technical Recruitment Consultancy

Adepto Technical Recruitment Consultancy

Verified Company

Merseyside, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

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Description

QC Analyst - Pharmaceuticals - Merseyside

Job Summary

The purpose of the QC Incoming and Components Analyst role is to compliantly perform Primary QC inspection, Sampling of raw materials, components laboratory testing, data review and data interpretation in accordance with approved Standard Operating Procedures(SOPs) for all primary and secondary packaging components.

QC Incoming and components analysts will be required to support release of raw materials and components for use in manufacture.

QC incoming and component's Analysts may also be required to participatein technical and validation studies in support of both departmental and site objectives.

Principal Accountabilities

The primary responsibilities of a QC Incoming and Components Analyst is to compliantly perform component testing, data review and data interpretation in accordance with approved SOPs.

It is expected that analysts consistently work to the highest standardsof 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 raw material and component sampling.

It is the responsibility of QC Incoming and Components Analysts to communicate their findings as a result of testing/inspections 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.

It is the responsibility of QC Incoming and Components Analysts, when assigned, to complete critical tasks such as:

Instrument Maintenance and Calibration
Sampling booth cleaning and monitoring
Initiation of deviations
Initiation, and completion, of CAPAs
Completion of Change Control actions
Updates and reviews of SOPs
Participation in quality risk assessments

It is the responsibility of QC Incoming and Components Analysts to participate in laboratory administration tasks such as:

HSE risk assessment completion, review and adherence
Archiving of laboratory documentation,
Ordering of materials and consumables
Maintenance of QC sample and reagent stores
Ensuring a clean and safe workplace for all associates

It is the responsibility of QC Incoming and Components 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

It is the responsibility of QC Incoming and Components Analysts to ensure that they communicate professionally and effectively with their fellow team members and the QC Analytical leadership team.

Impact/Influence/Liaison

QC Incoming and Components Analysts are considered to be a key member of the Quality team in supporting timely component 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 interdepartmental meetings as required by the leadership team

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 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

Minimum Education Requirements
QC Analysts must be educated to NVQ level 2 or equivalent in a relevant scientific discipline

QC Analysts must be experienced in the relevant testing discipline, ideally within the pharmaceutical industry having worked to cGMP standard