QA TECHNICIAN
DEPARTMENT: QUALITY
REPORTING TO: SITE QUALITY HEAD
HOURS
- 40 hours per week
- Monday to Friday
- Rotating day and evening shift (07:45 16:15 and 15:45 12:15)
MAIN DUTIES AND RESPONSIBILITIES:
The post holder will perform QA activities in support of manufacturing to ensure the Larne Site operates in compliance with regulatory requirements and Millicent business objectives..
JOB PURPOSE:
The purpose of this job is to ensure manufacturing at the Larne site is carried out in compliance with regulatory authorisations.
GENERAL DUTIES
Provide QA cover for manufacturing shifts as required.
Carry out spot checks on ongoing manufacturing/packaging operations
Ensure that all planned changes or deviations have been notified and documented in accordance with written procedures.
Ensure any additional sampling, inspection, tests and checks have been initiated and performed as appropriate to cover planned changes or deviations.
Review completed batch records and ensure all deviations /issues are addressed satisfactorily.
Ensure all necessary quality records have been completed and endorsed appropriately by trained personnel.
Assist in the maintenance of QA documentation for commercial manufacture
Assist in the development and maintenance of the Millicent Quality Management System
Assist in the preparation of validation protocols and reports for manufacturing and test equipment and processes.
Collate Quality metrics in line with Larne site requirements.
Perform Quality review of Larne Site SOPs relating to commercial production, site qualification and operational activities.
Undertake any other duties, which may be assigned by Senior Management.
ESSENTIAL CRITERIA:
- Minimum A level (Grade A-C) / NVQ in related scientific discipline (Biology, Chemistry, Laboratory Science)Ability to follow written and verbal instructions in English.
- Strong attention to detail and accuracy.
- Ability to work effectively as part of a team.
- Proficiency in Microsoft Office, particularly?Word and Excel
- Right to work in the UK.
DESIRABLE CRITERIA:
- At least 1 years experience working within a laboratory environment
- GMP experience.
- Experience of preparing risk assessments for materials and processes ie COSHH assessment
- Experience of QC testing
BENEFITS:
- Company sick pay
- Length of service awards
- Discretionary bonus scheme
- Health care plan
- On site parking
- Cycle to work scheme
- 34 day leave per year inclusive of public holidays (FTE)
- Wedding leave
- Competitive salary
Applicants must have the right to work in the UK
WHJS1_NI
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