Quality Consultancy Services (QCS) Opportunities within Scitech: January 2013

These positions are available across our regions, covering UK, The Netherlands and Belgium:

 

Senior GMP Compliance Expert:

Scitech is looking for an accomplished PharmaBio professional, educated to degree level and with more than 10 years GMP Compliance experience within the industry. Particular interest would be from individuals with international GMP experience of working with the EU and FDA medicines inspectorates. A broad knowledge of Quality Systems Management associated with aseptic processing, process validation, filling and packaging is expected. Handling post warning letter reports or consent decree together with operating in a coaching and / mentoring role, would be beneficial.

 

Laboratory Equipment Validation:

Experience with validation of laboratory equipment, performing risk assessments, Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ). Experience of writing reports for Regulatory Inspections.

 

Analytical Method Validation:

Experience of laboratory test method validation. Determining accuracy, precision and robustness of the assay parameters.

 

Radiopharmaceuticals Experience:

Familiar with premises and equipment for the manufacture of radioactive pharmaceutical products. Validation experience of critical parameters would be useful.

 

Quality Management System (QMS):

Exposure to the necessary tools associated with QMS: Documentation practices and control, regulatory and internal audits, ISO expertise, supplier audits, change control, corrective and preventative actions (CAPA), customer complaints and training.

 

Regulatory Compliance:

Expertise with EU and FDA regulations, audit / inspection response writing, regulatory intelligence and quality procedures, particularly with experience in Process Validation and equipment sterilisation.

 

Validation:

Writing Validation Plans, Risk Assessments, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and final reports. Experience of process validation and cleaning validation would be an advantage.

‘Hands on’ experience of thermal mapping of stability chambers, laboratory equipment, freezers, autoclaves and ovens.

Execution of utilities, HVAC, Water Systems, Clean Steam, compressed air and gases.

Pharmaceutical and Biological process equipment validation for sterile and non-sterile formulations.

 

Computer Systems Validation (CSV), IT and Automation:

Expertise with EU,US and GAMP 5 requirements for validation of laboratory and production equipment controlled by computers. Determine what requires validation and the extent of the validation required. Writing, execution and /or review of validation plans, protocols and reports.

 

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