Contact: Niamh Hlubek
Telephone: 086 8168298
QC In Process Analyst - Contract
Our client, a medical device company in Cork are currently looking to recruit QC Analyst for their site on a contract basis.
- 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:
- 4-cycle shift (initially person may be on days for a no. of weeks to allow for training to be completed)
- Key analytical technique required: HPLC
- Other desirable techniques: A280 and Nephelometry testing, residual protein assay, TOC analysis
- 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.
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 for compliant and flawless execution
- Takes personal responsibility for decisions that successfully build customer value
- Effectively manages and adapts to change
- Demonstrates the courage to stand alone on ideas and opinions that differ from others
- Listens effectively and remains open to other’s ideas.
- Works effectively with people that have diverse styles, talents and ideas
- Maintains the highest standards of ethical behaviour
- Treats people with dignity and respect
Significant Environmental, Health and Safety Considerations
- All employees are required to comply with the requirements of the company’s Environmental Health and Safety Policy, Safety
- Statement, associated EHS Procedures and local legislation.
- Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
- Comply with EHS rules and procedures always.
- Understand the potential EHS impact of their activities
- Attend and participate in EHS training as required
- Use PPE and safety equipment as required.
- Report all incidents, accidents, and near miss events.
- Report unsafe plant, equipment, acts, procedures or issues
- Make suggestions to improve health and safety in the workplace.
- Actively participate in work area EHS teams.
- Not turn a ‘blind eye’ to unsafe acts or situations
For further information on this QC Analyst role in Cork please contact Niamh Hlubek 086 8168298 / email@example.com
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