QC Compliance Specialist (6 month contract)

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. This is a key role in the
Quality Control area reporting to the QC Compliance Supervisor.

KEY RESPONSIBILITIES:

  • Write and revise standard operating procedures (SOPs), Finished Product Procedures, Raw Material Testing Procedures, and other QC associated GMP documents.
  • Displays competency in the following technical areas: Chromatography (HPLC, GC, UPLC), Spectroscopy (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, method validation protocol and report.
  • Prepare and review of Lab incident reports, Out of Specification, Out of Trend, Out of Expectation results.
  • Effectively handle the quality events (Deviations, CAPA, Change Control) to its closure.
  • 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.
  • 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 always 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.
  • Proficiency with Microsoft applications, including Word and Excel and environmental systems

  • Displays key behaviours such as:

     

    • Takes direction and asks questions
    • Relate 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, Chromatography, Spectroscopy, 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.
  •  

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.

PHYSICAL DEMANDS: Health & Safety requirements (e.g., 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 Realoch 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

HOURS OF WORK

  • 08:30 – 17:00 (Monday – Thursday)
  • 08:30 – 16:00 (Friday)

QC Compliance Specialist (6 month contract)

Reference No: J0662
Loughrea, Co. Galway