QC R&D Compliance Analyst

Loughrea, Co. Galway

About Chanelle Pharma:

This is an opportunity to be part of a dynamic team within the QC 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.

BASIC SUMMARY:

  • To carry out analytical testing on Raw Materials, API and Excipients using the correct Analytical procedures to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs.
  • Preparation of ECP’s and Vendor Approval.
  • Analytical Method Transfers and Technical Transfers.
  • Method Verifications
  • Protocols and Reports
  • Approval of Materials and the issue of associated documents and labels.
  • Responses to Questions from 3rd
  • Writing Technical Reports.
  • Raw Material / API Equivalency / Method Verification.
  • To provide technical support as required by management.
  • To provide support as required to QC Analysts

KEY RESPONSIBILITIES:

  • Displays the capability to learn and understand methods showing competency in the following technical areas: HPLC, IR, UV, dissolution & physical testing.
  • Raw Material / API and excipient testing referencing API suppliers Analytical methods or Pharmacopeia methods.
  • ECP’s (Entry Controlled Procedures) preparation and Vendor Approval.
  • Raw Material / API Equivalency / Method Verification.
  • Analytical Method Transfer / Technical Transfer.
  • Approval of Materials and issue of associated documents and labels.
  • Responses to Questions from 3rd
  • Writing Technical reports.
  • 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 Raw Materials (API, excipients 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.
  • 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.
  • Liaise with QC Supervisors, R&D, QA, warehouse, production and planning so that timely reporting of results is achieved.
  • Ensure timely feedback of all queries as appropriate.
  • To bring to the notice of the QC Supervisor any discrepancies, deviations or non-conformances in testing or work practice.
  • Perform detailed root cause investigations into out of specification results or any analytical errors that occur in the laboratory.
  • 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.

    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 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.

     

    QUALIFICATION/ REQUIREMENTS

    • 3rd level qualification – bachelor’s degree in a chemistry-based discipline.
    • Experience in Analytical Method Transfer, Technical Transfer, Method Verification, Protocols, Reports.
    • 3 + years’ experience in a Snr QC Analyst/ QC Analyst role.
    • Strong computer skills in MS Office.
    • Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines


      PHYSICAL DEMANDS: Health & Safety requirements (eg. Manual Handling Training)

      • To take reasonable care for their own safety, health, and welfare at work and that of any other person that may be affected by their acts or omissions while at work.
      • To cooperate with Chanelle or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisions.
      • Adheres to safety regulations by ensuring correct usage of PPE in the lab area.
      • Reports to the supervisor or health and safety representative without unreasonable delay any defects in plant, equipment, place of work, system of work which might endanger safety, health or welfare of themselves or any employee, contractor, or visitor to the company.
      • Keeps work area safe, clean and tidy.
      • Not too intentionally or reckless interfere with or misuse any appliance, protective clothing, convenience, equipment or other means or thing provided.
      • Required training.
      • Manual Handling training,
      • Glove removal and disposal training,
      • Working with chemicals
      • Disposal of waste
      • Working on PC


        WORK ENVIRONMENT: (eg. Office, Production)

        • Laboratory

     

QC R&D Compliance Analyst

Reference No: J0714
Loughrea, Co. Galway