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Description
We are seeking a Quality Control Analyst to carry out analytical testing on finished products and raw materials using the correct procedures to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customers’ needs. The QC Analyst will also be required to provide technical support as required by management.
Description
We are seeking a Quality Control Analyst to carry out analytical testing on finished products and raw materials using the correct procedures to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customers’ needs. The QC Analyst will also be required to provide technical support as required by management.
This role will report to the Quality Control Manager.
Location: Onsite in our Loughrea laboratory (5 days per week).
As a Quality Control Analyst, you will be responsible for:
* Displaying the capability to learn and understand methods, showing competency in the following technical areas: HPLC, IR, UV, dissolution & physical testing.
* Maintaining and following all relevant Standard Operating Procedures (SOP’s).
* Adhering to the existing methods with reference to pharmacopoeia’s, specifications, regulations and industry standards.
* Full analysis of raw materials in a timely manner using appropriate analytical techniques with limited analyst related OOS.
* Full analysis of finished products (tablets, boluses, veterinary drenches etc) in a timely manner using appropriate analytical techniques with limited analyst related OOS.
* Full analysis of contract manufactured products in accordance with customer specifications with limited analyst related OOS.
* Incoming inspection of foils, labels, bulk finished goods and injectable.
* Calibrating and maintenance of laboratory equipment as per calibration procedures.
* Supporting the laboratory testing schedule to achieve an efficient QC system and Customer Service level of >95%.
* Maintaining all laboratory logbooks, notebooks and associated documentation to GLP.
* Liaising with team leader/supervisor and production so that timely reporting of results is achieved.
* Ensuring timely feedback of all queries as appropriate.
* Alerting the team leader/supervisor of any discrepancies, deviations or non-conformances in testing or work practice.
* Display ability and follow up on Corrective Actions.
* Sending out samples for external analysis when requested.
* Participating in internal/external audits.
* Liaising with external suppliers/vendors in relation to QC consumables.
* Ensuring existing quality procedures are followed and where appropriate suggestions/change control forms are prepared so that the quality system will be continuously improved.
* Adhering to any agreed internal laboratory rota tasks.
* Maintaining good housekeeping and hygiene within the laboratory.
* Always adhering to laboratory safety measures, highlighting areas for improvement.
* Ensuring the laboratory is kept tidy and that GLP/GMP standards are always adhered to.
* Ensure records pertaining to QC are all kept up to date and filed properly.
* Displaying key behaviours such as:
o Takes direction and asks questions.
o Relates well to the rest of the team.
o Develops own technical skills.
o Takes a methodical, systematic and structured approach to organising work.
o Ability to prioritise decision making differentiating between urgent and non-urgent.
o Escalates issues appropriately.
o Offers to help others when needed and creates a sense of harmony in the team.
o Displays flexibility and shows willingness to learn and do that little bit extra.
Education & Experience:
* Bachelor’s degree in a chemistry-based discipline.
* 2 – 5 years experience in a QC Analyst role.
* Strong computer skills in MS Office.
* Experience of working within a pharmaceutical cGLP environment with demonstrated hands on experience of EU, GMP and US FDA Guidelines.
* Applicant must have eligible work permit to work in Ireland.
Skills & Competencies:
* Competency in the following technical areas: HPLC, IR, UV, dissolution & physical testing.
* Ability to build relationships and collaborate with others.
* Good communication skills, both verbal and written.
* Maintains the highest standards of ethical behaviour and escalates issues appropriately.
* Flexible and shows willingness to learn to develop technical skills.
* Takes a methodical, systematic, and structured approach to organising work.
* Positive and proactive person who is energised by having great responsibility.
Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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