QA Technician

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 3rd level qualification in related scientific discipline (Biology, Chemistry, Laboratory Science
• Experience of working in a recognised quality system
• Strong attention to detail and accuracy.
• Ability to work individually and as part of a team.
• Good communication skills
• Proficiency in Microsoft Office, particularly? Word and Excel
• Right to work in the UK

DESIRABLE CRITERIA:

• Experience of working in the Pharmaceutical industry
• GMP knowledge.
• Experience of document control and report writing
• Ability to work under pressure.

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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