QC Analyst

PE Global (UK); New Brunswick; On-site; CAD 55,504 - 74,005; Full time

Job summary

A leading pharmaceutical company is seeking a QC Analyst for a six-month contract based in Dartford, UK. The role involves ensuring compliance with laboratory standards, conducting analytical testing, and preparing SOPs. A science degree and experience in a cGXP environment are required, with knowledge in particle size analysis and HPLC method development strongly preferred. This position requires flexibility with a rotating shift pattern including mornings, afternoons, and nights.

Qualifications

• Proven experience in a cGXP environment is essential.
• Knowledge of particle size analysis techniques is required.
• Experience with HPLC Method Development and Validation is essential.

Responsibilities

• Conduct tasks as per defined Risk & COSHH assessments.
• Maintain laboratory cleanliness per EHS standards.
• Execute analytical testing per cGMP requirements including routine particle size analysis.
• Prepare Standard Operating Procedures (SOPs) and analytical test reports.

Skills

Laboratory operation in a cGXP environment

Particle size analysis knowledge

HPLC Method Development and Validation

GMP compliance

Education

Science graduate or higher

Job description

Overview

PE Global are currently recruiting for a QC Analyst for an initial 6 month contract role with a leading multinational pharma client based in Dartford.

This position is based on a rotating shift pattern, including morning, afternoon, and night shifts. Flexibility is required.

Job Responsibilities

• Ensure all tasks are conducted in accordance with defined Risk & COSHH assessments.
• To keep at all time the laboratory to the required cleanness with the EHS standards
• To support identification, reporting and implementation of EHS improvement within the QC laboratory via Entropy in alignment with management.
• To understand and correctly execute written instructions
• To ensure timely completion of any training in Compliancewire
• To maintain related responsibilities in compliance with GMP requirements
• To identify and trigger a laboratory investigation, deviation, CAPA or change control under the supervision of a more senior analyst
• To keep up to date with industry/regulatory developments in relation to particle size technology and cleaning verification/validation techniques
• Perform analytical testing in an accurate, timely and efficient manner, consistent with cGMP requirements. Testing may include, but is not limited to, routine particle size analysis (Malvern Mastersizers, Sympatec), cleaning verification (HPLC), identification testing (FTIR and Raman), method development and validation (including particle size and cleanability assessments), DSC, Light microscopy, SEM, Moisture content (Karl Fischer), method optimisation and trouble-shooting, technology transfer and pharmacopoeia analyses as appropriate
• To understand basic principles of PSA / HPLC/DSC equipment and methods
• To swab processing equipment
• Prepare test methods for analytical testing and cleaning verification analysis.
• Prepare Standard Operating Procedures (SOP’s), including corporate and departmental guidelines.
• Prepare analytical test reports for submissions to clients or the Company’s other departments. These include, but are not limited to, Statement of Results, Certificate of Analysis and Cleaning Certificates, Method Qualification/Validation Protocols, Method Qualification/Validation Reports and Laboratory Technical Transfer Studies.
• Experience of GMP requirement with regards to Deviation management, out of specification investigation, reporting incidents, out of tolerance and change controls.
• Ensure that instrumentation used is correctly calibrated and operated in accordance with SOPs or client/manufacturing instructions.
• Ensure compliance with data integrity requirements of laboratory equipment and software systems.
• Communicate with the QC Laboratory staff, QC Manager, Operations, QA, client representatives, service providers and equipment vendors as appropriate.
• Maintain accurate and up-to-date training records.
• Attend training seminars and sessions related to any of the above-mentioned topics, if applicable.
• To perform microbiological sampling including generation of sample labels, organizing sample collection and completing sample submission form

Requirements

• Science graduate or higher with proven experience of laboratory operation in a cGXP environment or extensive industry experience
• Particle size analysis knowledge/experience
• HPLC Method Development and Validation
• GMP

Please click the link below to apply

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***