QC Analyst
About Chanelle Pharma:
Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Chanelle Pharma 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. We are passionate about understanding and addressing the challenges facing our 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. We are looking for individuals who will support and drive Chanelle Pharma’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 responsible for carrying out analytical testing on finished product & raw materials using the approved procedures in order to comply with cGMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs.
KEY RESPONSIBILITIES:
- 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.
- Adherence to regulatory and industry compliance and data integrity expectations.
- Displays technical competency and full understanding of methods and equipment relating to the following areas: HPLC, UPLC, GC, IR, UV, ICP, particle size, dissolution & physical testing.
- Perform full analysis of raw materials in a timely manner using appropriate analytical techniques with limited analyst related OOS.
- Perform full analysis of finished product (tablets, boluses, veterinary drenches etc) in a timely manner using appropriate analytical techniques with limited analyst related OOS.
- Perform 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 injectables.
- 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.
- 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.
Competencies:
- Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands.
- Excellent communication skills, both verbal & written.
- Ability to prioritise decision making differentiating between urgent and non-urgent.
- Ability to build relationships and collaborate with others.
- Maintains the highest standards of ethical behaviour. Escalates issues appropriately.
- Practical, action-orientated approach to managing priorities.
- Strong analytical ability and associated problem solving.
- Flexible and shows willingness to learn to develop technical skills.
- Takes a methodical, systematic and structured approach to organising work
- The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
QUALIFICATIONS:
- 3rd level qualification – Bachelor’s degree in a science-based discipline.
- Minimum of 8 to 10 years’ experience in a pharmaceutical’s environment.
- Strong computer skills in MS Office
- Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines
