Senior QC Analyst (12 Month Contract)
Posted 2 hours 52 minutes ago by Uniting Holding
In this role, you will be required to carry out analytical testing on finished products (Stability & Release) & 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 customer's needs. You will also be required to provide technical support as required by management.
Location:Onsite at our facility in Loughrea.
As our Senior QC Analyst, your key responsibilities will be as follows:Competency in the following technical areas: HPLC, IR, UV, dissolution & physical testing.
Maintain and follow all relevant Standard Operating Procedures (SOP's).
Adherence 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.
Full analysis of finished product (tablets, boluses, veterinary drenches etc) in a timely manner using appropriate analytical techniques.
Full analysis of contract manufactured products in accordance with customer specifications.
To support the laboratory testing schedule to achieve an efficient QC system and Customer Service level of >95%.
Incoming inspection of foils, labels, bulk finished goods and injectables.
Calibration and maintenance of laboratory equipment as per calibration procedures.
To maintain all laboratory logbooks, notebooks & associated documentation to GLP.
Liaise with team leader/supervisor & production so that timely reporting of results is achieved.
Ensure timely feedback of all queries as appropriate.
To bring to the notice of the team leader/supervisor any discrepancies, deviations or non conformances in testing or work practice.
Timely review of OOS / LIR's; providing technical support to review and close in a timely manner.
Display ability and follow up on Corrective Actions.
Participating in internal/External Audits.
Liaising with external suppliers/vendors in relation to QC consumables.
Ensure existing quality procedures are followed and where appropriate suggestions/change control forms are prepared so that the quality system will be continuously improved.
To adhere to any agreed internal laboratory rota tasks.
To maintain good housekeeping and hygiene within the laboratory.
Adherence to laboratory safety measures at all times highlighting areas for improvement.
Ensuring that 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.
Displays key behaviours such as:
Takes direction and asks questions.
Relates well to the rest of the team.
Develops own technical skills.
Takes a methodical, systematic and structured approach to organising work.
Ability to prioritise decision making differentiating between urgent and non-urgent.
Escalates issues appropriately.
Offers to help others when needed and creates a sense of harmony in the team.
Displays flexibility and shows willingness to learn and do that little bit extra.
Any other duties as assigned by the Supervisor or Manager.
If decided appropriate it may be decided to amend/update any of the above responsibilities.
3rd level qualification - bachelor's degree in a chemistry-based discipline.
5 + years' experience in a Snr QC Analyst/ QC Analyst role.
Strong computer skills in MS Office.
Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines.
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 & written.
Maintains the highest standards of ethical behaviour.
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 energized 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.