QC Analyst
Responsibilities
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.
Key point to note:
Key analytical technique required: HPLC and experience with troubleshooting instrumentation/method issues
General 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 to ensure that all
methods meet ICH, 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 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
license 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.
• 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.
• In process control testing and activities to support the production
Units
• Liaisons with Operations department regularly throughout the day to ensure testing activities are completed in an efficient manner and issues rectified
Qualifications and experience
• A third level qualification of a scientific/technical discipline is
required.
• Knowledgeable of FDA/EMEA regulatory requirements applicable
to biologics and/or pharmaceuticals.
• Builds strong productive relationships.
• Demonstrates ability to work with teams and individuals
• Asserts personal ideas and opinions using persuasion to
influence others
• Seeks opportunities to grow and develop professionally
• Uses best practices to improve business operations
• Holds self-accountable
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