POSITION SUMMARY: This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures as required by Good Manufacturing Practice (GMP).
Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.
GENERAL SCOPE OF RESPONSIBILITIES: Achieves competency in laboratory methods and procedures.
Trains other QC analysts in laboratory methods and procedures when required.
Performs analytical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR USP and EP guidelines.
Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
Writes, executes, reports and reviews IQ/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use.
Performs routine and non-routine analytical testing activities.
Review and approval (where appropriate) of laboratory test results.
Ensures that testing and results approval are completed within agreed turnaround times.
Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
Ensures QC activities are carried out in compliance with product licence commitments, cGMP, and company quality standards.
Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.
Anticipates and plans for future requirements in the area.
Deals with non-conformances/ deviations in an accurate and timely manner.
Deputizes for the QC Team Leader as appropriate.
Maintains and develops knowledge of analytical technology as well as cGMP standards.
QUALIFICATIONS AND EXPERIENCE: ESSENTIAL: A third level qualification in a scientific/technical discipline required.
A minimum of 2 years experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.
Skills: Microbiology analytical testing validation Benefits: Work From Home