QC Analyst

Galway

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 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.


This role reports to the QC Manager.

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 (SOPs).
  • 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 adhered to at all times.
  • Ensure records pertaining to QC are all kept up to date and filed properly.

 

PERSON SPECIFICATION:

  • Bachelor’s degree in a science-based discipline with a minimum of 0-5 years’ experience in a pharmaceutical manufacturing environment.
    • Displays key behaviours such as:
  • Displays a positive outlook with strong coaching skills, maintaining interest at all times.
  • Takes a methodical, systematic and structured approach to organising work.
  • Escalates issues appropriately.
  • Displays flexibility, willingness to succeed and goes the extra mile.
 

COMPETENCIES:

  • 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
  • Working with computers, paper files – office work environment 

QC Analyst

Galway