QC Data and Document Reviewer

QC DATA AND DOCUMENT REVIEWER

DEPARTMENT: QUALITY

REPORTING TO: QUALITY CONTROL MANAGER

HOURS

• 40 hours per week
• Monday to Friday

MAIN DUTIES AND RESPONSIBILITIES:

The post holder will review data and documents within the Quality Control department.

JOB PURPOSE:

The purpose of this job is to ensure the quality, accuracy, and regulatory compliance of analytical data within GMP/GLP environments.

GENERAL DUTIES

• Ensure the quality, accuracy, and regulatory compliance of analytical data within GMP/GLP environments.
• Check and review laboratory data, raw chromatographic data, laboratory notebooks, equipment logbooks to ensure compliance with analytical methods, specifications and SOPs.
• Evaluate and approve standard operating procedures (SOPs), analytical protocols and reports.
• Manage equipment calibration and qualification schedules, associated master plans and summary reports.
• Identify data gaps or documentation errors and communicate directly with laboratory staff to address issues.
• Review testing datasets, including (but not limited to) HPLC / UHPLC / GCHS, Karl Fischer water determination, spectroscopic data and reference standard certification.
• Manage and plan daily activities to meet strict project timelines and ensure clear, concise record-keeping.
• Manage their time so as to accommodate the tasks allocated to them on a daily basis.
• Undertake any other duties, which may be assigned by Management.

ESSENTIAL CRITERIA:

• Chemistry (or closely related) degree
• HPLC /UHPLC / GC methodology and techniques
• Knowledge and understanding of GMP aspects of laboratory software applications.
• Proficiency in Microsoft Office, particularly?Word and Excel
• Must be able to work individually and as part of a team.
• Right to work in the UK.

DESIRABLE CRITERIA:

• Previous experience in a quality control laboratory (pharmaceutical preferred)
• Knowledge and understanding of the development and validation of HPLC and GC methods.
• Good interpersonal skills.

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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