QC Team Lead

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 department. ·

The successful candidate will be responsible for managing a team of QC analysts/Senior QC analysts on a day-to-day basis alongside senior management within a well-established QC laboratory.

This is an ideal role for someone with 4 + years’ experience within a laboratory/ QC role looking to progress into a managerial position. Previous people management/ Team Lead experience is desirable.

KEY RESPONSIBILITIES:

  • Ensure completion of testing to allow for timely release of raw materials for use in manufacture and finished product for release to the market.
  • Provide technical guidance in the event of equipment failure, calibration failure, out of specification results and any other issues as appropriate. Ensure all laboratory equipment is maintained and calibrated.
  • Perform detailed root cause investigations into out of specification results or any analytical errors that occur in the laboratory
  • Ensure timely completion of method transfer activities in accordance with relevant procedures.
  • Displays 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.
  • Calibration and maintenance of laboratory equipment as per calibration procedures.
  • To support the laboratory testing schedule to achieve an efficient QC system and Customer Service level of >95%.
  • To maintain all laboratory logbooks, notebooks & associated documentation to GLP.
  • Ensure timely feedback of all queries as appropriate.
  • To bring to the notice of the manager 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.

 

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 science-based discipline.
  • 4+years’ experience in a manufacturing/ pharma environment.
  • People Management skills and experience desirable.
  • Strong computer skills in MS Office.
  • Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines

 

Work Environment (eg. Office, Production)

  • Laboratory

QC Team Lead

Reference No: J0302
Galway