QC Compliance Officer

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. We are looking for an individual 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.
Reporting to the QC Manager, the QC Compliance Officer will monitor Quality Systems for the QC/QA department and continuously improve areas impacted by deviations and design appropriate CAPAs. They will also provide technical support as required by management.

KEY RESPONSIBILITIES:

  • Write and revise standard operating procedures (SOPs)
  • Prepare finished product and raw material test procedure
  • Displays competencies in the following technical areas: HPLC, IR, UV, dissolution & physical testing etc.
  • Adherence to the existing methods with reference to pharmacopoeia’s, specifications, regulations and industry standards.
  • Prepare analytical method transfer protocol and report
  • Prepare and review of out of specification, Out of Trend, Change control
  • Review calibration and maintenance of laboratory equipment as per calibration procedures
  • To maintain all laboratory logbooks, notebooks & associated documentation to GLP standard
  • 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 Manager/supervisor any discrepancies, deviations or non-conformances in testing or work practice
  • Display ability and follow up on Corrective Actions
  • Participating in internal/external audits
  • 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 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
  • Proficiency in Microsoft applications, including Word and Excel and environmental systems
  • 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 QC team leader/supervisor or manager

If decided appropriate it may be decided to amend/update any of the above responsibilities. 

COMPETENCIES:

  • Competency in the following areas: SOP, FPP, CCF, Deviation, CAPA, 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 and 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 science-based discipline.
  • Strong computer skills in MS Office.
  • Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines.
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QC Compliance Officer

Galway