QC Analyst

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 Compliance wire
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**
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