Our client is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Our client is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. They are passionate about understanding and addressing the challenges facing their medical and veterinary customers and bringing them innovative and effective products and solutions.
The Opportunity:
This is an opportunity to be part of a dynamic team within the Quality Control function. They are looking for individuals who will support and drive the company’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
In this role, you will be asked to carry out analytical testing on finished products & 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 asked to provide technical support as required by management.
Key Responsibilities:
- Displays the capability to learn and understand methods showing 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 with limited analyst related OOS.
- Full analysis of finished product (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.
- Calibration and maintenance of laboratory equipment as per calibration procedures.
- To support the laboratory testing schedule in order to achieve an efficient QC system and Customer Service level of >95%.
- 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.
- 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.
- 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.
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 & 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.
The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required and may be subject to change.
Qualifications:
- 3rd level qualification – Bachelor’s degree in a chemistry-based discipline.
- 4 + years’ experience in a Snr QC Analyst/ QC Analyst role.
- People management experience.
- Strong computer skills in MS Office.
- Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines.
